Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
Official Title
A Pilot Randomized Factorial Trial to Promote Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
Acronym
Not provided
Organization
UNC Lineberger Comprehensive Cancer CenterOTHER
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2, 2023Actual
Primary Completion Date
Sep 30, 2024Actual
Completion Date
Sep 30, 2024Actual
First Submitted Date
May 24, 2023
First Submission Date that Met QC Criteria
Jun 1, 2023
First Posted Date
Jun 2, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Nov 12, 2025
Results First Submitted that Met QC Criteria
Dec 5, 2025
Results First Posted Date
Dec 24, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 5, 2025
Last Update Posted Date
Dec 24, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
UNC Lineberger Comprehensive Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality.
Detailed Description
There are around 1 million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk for chronic health conditions like cardiovascular disease, metabolic syndrome, secondary cancers, premature aging, and premature death. Modifiable lifestyle factors contribute to and compound risks for late and long-term health effects from cancer and its treatment, making them high-impact targets for behavioral interventions. International consensus guidelines recommend cancer survivors of all ages be physically active, consume a healthy diet, and achieve and maintain a healthy weight. Fewer than half of young adult cancer survivors meet guideline recommendations for vegetable intake, physical activity and the majority self-report having an overweight/obese BMI. To date, there are few physical activity interventions, and no nutritional interventions designed specifically for young adult cancer survivors. Digital behavior change interventions have emerged as feasible and efficacious approaches to reach and address unmet needs among young adult cancer survivors as they overcome barriers of time, flexibility, affordability, and access. Reaching these populations has been facilitated by digital tools like wearable devices that enable real-time data capture to guide the provision of individualized feedback and tailored goal setting based on personal progress. This pilot trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to evaluate the feasibility of 4 intervention components to improve physical activity and nutrition behaviors among young adult cancer survivors. Young adult cancer survivors (n=80), diagnosed between ages 18-39, will be recruited to receive a core 3-month digital physical activity and nutrition intervention that includes evidence-based lessons and behavioral skills training with an emphasis on adherence to American Cancer Society (ACS) guidelines for cancer survivors and self-monitoring of physical activity and dietary behaviors. Additionally, participants will be randomized to four intervention components--each with two levels-- including: 1) simplified dietary tracking (daily tracking of green (low-calorie, high nutrients) vs. red (high-calorie, high-fat, low nutrients) foods), 2) dietary goals using simplified approach (daily goals vs. no goals), 3) supportive text messages (yes vs. no), 4) lesson delivery (all provided once vs. weekly). Assessments of outcomes will be conducted at baseline, 6 weeks, and 3 months to accomplish the following specific aims: 1) Evaluate the feasibility and acceptability the intervention at 3 months; 2) Evaluate intervention effects on change in physical activity and diet quality; 3) Evaluate intervention effects on secondary outcomes at 6 weeks and 3 months; and 4) Explore whether theoretical constructs (perceived competence, self-regulation, self-efficacy, and perceived relatedness) mediated the effects of the intervention on change in health behaviors at 3 months.
Conditions Module
Conditions
Physical Activity
Neoplasms
Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
72Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once
Experimental
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Lessons Weekly
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Green)
Behavioral: Nutrition Goals (Yes)
Behavioral: Supportive Text Messages (Yes)
Behavioral: Lesson Delivery (Once)
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons
Experimental
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Green)
Behavioral: Nutrition Goals (Yes)
Behavioral: Supportive Text Messages (Yes)
Behavioral: Lesson Delivery (Weekly)
Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once
Experimental
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Green)
Behavioral: Nutrition Goals (Yes)
Behavioral: Supportive Text Messages (No)
Behavioral: Lesson Delivery (Once)
Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Experimental
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Core Intervention
Behavioral
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Accrual Rate
Number of participants who agreed to participate divided by the number of months of recruitment.
End of study enrollment period (7 months).
Participation Rate
Percentage of consented participants who were randomized.
End of study enrollment period (7 months).
Retention Rate
Number of intervention participants who completed 3-month measures divided by the number randomized to intervention arms.
3 months
Secondary Outcomes
Measure
Description
Time Frame
Acceptability: How Satisfied Are You Overall With the Program You Received?
1-item measure; a benchmark of 80% of participants answering "somewhat" or "very" satisfied would indicate acceptability
3 months
Adherence to Physical Activity Monitoring.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Current age 18-39 years at the time of consent
Diagnosed with invasive cancer malignancy between the ages of 15-39 years
Diagnosed with invasive malignancy in the last 10 years of diagnosis, and with no evidence of progressive disease or second primary cancers
Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving "maintenance" therapy to prevent recurrences
No pre-existing medical conditions(s) that preclude adherence to an unsupervised exercise program including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
Not currently meeting guideline recommendations of 150 minutes/week moderate to vigorous physical activity (self-report) and guideline recommendations for fruit and vegetable consumption (self-report)
Have the ability to read, write and speak English
Have access to the Internet on at least a weekly basis
Possession and usage of an Internet e-mail address or willingness to sign up for a free email account (e.g., gmail)
Have smartphone with internet access and text messaging plan
Be willing to be randomized to any condition
Exclusion Criteria:
History of heart attack or stroke within past 6 months
Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
Health problems which preclude ability to walk for physical activity
Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency
Report a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa)
Plans for major surgery (e.g., breast reconstruction) during the study time frame
Current participation in another physical activity or weight control program
Currently using prescription weight loss medications
Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
Currently exercising > 150 minutes/week of moderate-to-vigorous intensity physical activity
Currently consuming > 5 servings of fruits and vegetables/day.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
39 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Erin M Coffman, MA
University of North Carolina, Chapel Hill
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Lineberger Comprehensive Cancer Center
Chapel Hill
North Carolina
27514
United States
References Module
Citations
Not provided
See Also Links
Label
URL
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Individuals who signed informed consent and then completed all baseline measurement procedures (online surveys and remote weight measurements) and remained eligible were considered enrolled and were randomized to 1 of 16 conditions.
Recruitment Details
Recruitment occurred from October 2023 and April 2024; remote recruitment across the continental United States. 220 individuals completed the online screening survey; 83 were initially eligible; out of those, 11 completed informed consent but were ineligible due to no longer being interested in participating or incomplete baseline measurement procedures, and 72 completed informed consent and all baseline assessment procedures and were randomized and enrolled in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Condition 1
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
FG001
Condition 2
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jul 9, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
This study uses a full factorial experimental design testing the efficacy of four intervention components, each with two levels
Primary Purpose
Supportive Care
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Green)
Behavioral: Nutrition Goals (Yes)
Behavioral: Supportive Text Messages (No)
Behavioral: Lesson Delivery (Weekly)
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Experimental
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Green)
Behavioral: Nutrition Goals (No)
Behavioral: Supportive Text Messages (Yes)
Behavioral: Lesson Delivery (Once)
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Experimental
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Green)
Behavioral: Nutrition Goals (No)
Behavioral: Supportive Text Messages (Yes)
Behavioral: Lesson Delivery (Weekly)
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Experimental
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Green)
Behavioral: Nutrition Goals (No)
Behavioral: Supportive Text Messages (No)
Behavioral: Lesson Delivery (Once)
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Experimental
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Green)
Behavioral: Nutrition Goals (No)
Behavioral: Supportive Text Messages (No)
Behavioral: Lesson Delivery (Weekly)
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once
Experimental
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Red)
Behavioral: Nutrition Goals (Yes)
Behavioral: Supportive Text Messages (Yes)
Behavioral: Lesson Delivery (Once)
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons
Experimental
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Red)
Behavioral: Nutrition Goals (Yes)
Behavioral: Supportive Text Messages (Yes)
Behavioral: Lesson Delivery (Weekly)
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once
Experimental
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Red)
Behavioral: Nutrition Goals (Yes)
Behavioral: Supportive Text Messages (No)
Behavioral: Lesson Delivery (Once)
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Experimental
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Red)
Behavioral: Nutrition Goals (Yes)
Behavioral: Supportive Text Messages (No)
Behavioral: Lesson Delivery (Weekly)
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Experimental
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Red)
Behavioral: Nutrition Goals (No)
Behavioral: Supportive Text Messages (Yes)
Behavioral: Lesson Delivery (Once)
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Experimental
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Red)
Behavioral: Nutrition Goals (No)
Behavioral: Supportive Text Messages (Yes)
Behavioral: Lesson Delivery (Weekly)
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Experimental
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Red)
Behavioral: Nutrition Goals (No)
Behavioral: Supportive Text Messages (No)
Behavioral: Lesson Delivery (Once)
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Experimental
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Behavioral: Core Intervention
Behavioral: Simplified Dietary Monitoring (Red)
Behavioral: Nutrition Goals (No)
Behavioral: Supportive Text Messages (No)
Behavioral: Lesson Delivery (Weekly)
Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons
Simplified Dietary Monitoring (Green)
Behavioral
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Simplified Dietary Monitoring (Red)
Behavioral
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons
Nutrition Goals (Yes)
Behavioral
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons
Nutrition Goals (No)
Behavioral
Participant will not be assigned a personalized weekly nutrition goal.
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Supportive Text Messages (Yes)
Behavioral
Participant will receive up to 5 supportive text-messages from the study staff per week.
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons
Supportive Text Messages (No)
Behavioral
Participant will not receive supportive text-messages.
Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Lesson Delivery (Once)
Behavioral
All behavioral lessons will be made available to participant simultaneously.
Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once
Lesson Delivery (Weekly)
Behavioral
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons
Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons
Number of days physical activity tracked, as measured by Fitbit.
Estimated mean change in MVPA from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
Change in physical activity from baseline to 3 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses the amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. PA Activities were classified as light, moderate, and vigorous based on their metabolic equivalent (MET) value and commonly used cut points. Moderate and vigorous activities were combined for self-reported minutes per week of MVPA. Range is 0 - no theoretical maximum.
Baseline, 3 months.
Dietary Intake: Healthy Eating Index (HEI)
Dietary intake will be defined as the change in HEI score as measured by the NCI's Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 3 months.The HEI consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the Dietary Guidelines for Americans. Estimated mean change in HEI from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
Baseline, 3 months
Weight (kg)
Estimated mean weight change in kg from baseline to 3 months. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).
Baseline, 3 months
Fried Physical Frailty : FRAIL Index
The FRAIL Questionnaire includes five components that assess: 1) self-reported fatigue (PROMIS Fatigue Short form), 2) weight loss, 3) comorbidities (11 items from University of North Carolina Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Physical Function Short Form), and 5) ability to overcome resistance (1 item from PROMIS Physical Function)). The number of positive responses for these components is summed to create the FRAIL index (range 0-5) and characterized as "Frailty Status"; 0-1: robust, 2: prefrail, and 3+: frail. Changes in Frailty Status from baseline to 3 months will be assessed.
Baseline, 3 Months
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. These measures assess relevant HRQoL domains for AYA cancer survivors that are most likely to be impacted during and after cancer treatment. The AYA PRO Core battery includes the following PROMIS short forms: depression, anxiety, fatigue, physical function, pain interference, emotional support, and cognitive function. For each measure, each question has five responses ranging in value from 1 to 5, which are summed to find the total raw score. Total raw scores are translated to a T-score, standardized with a population mean of 50 and a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured.
Baseline, 3 months
Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity)
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. Pain intensity was assessed with the 1-tiem PROMIS v1.0 pain intensity 1a, "In the past 7 days, how would you rate your pain on average?" Scored 0-10 from no pain to the worst imaginable pain.
Baseline, 3 months
Competence for Exercise and Nutrition
Changes in perceived competence from baseline to 3 months as measured using the Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence.
Baseline, 3 months
Self-efficacy for Exercise and Nutrition
Changes in self-efficacy from baseline to 3 months as measured using the Nutrition and Physical Activity Self-Efficacy Scale, a 10-items measured on a 4-point Likert scale that assesses an individual's confidence (where where 1 is 'very uncertain' to 4 'very certain') with in their ability to eat healthy foods (5 items) and exercise (5 items) in the presence of barriers. Self-efficacy for each behavior is calculated as the sum of the 5 Likert-type responses with a range of 5-20 for each subscale. Higher values indicate higher levels of self-efficacy for the behavior. Outcomes are changes in self-eficacy for exercise and self-efficacy for nutrition from baseline to 3 months.
Baseline, 3 months
Self-Regulation for Exercise and Nutrition
Changes in self-regulation from baseline to 3 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Ratings are on a 7-point Likert scale indicating agreement with statements regarding motivation for behavior change. Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for exercise and diet at 3 months.
Baseline, 3 months
Autonomy Support
Changes in perceived autonomy support from baseline to 3 months as measured using the Virtual Care Climate Questionnaire (VCCQ) a 15-item measure of perceived support for autonomy provided by the study team in a virtual care setting. Ratings are on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived autonomy support in a virtual setting.
Baseline, 3 months
FG002
Condition 3
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
FG003
Condition 4
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
FG004
Condition 5
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
FG005
Condition 6
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
FG006
Condition 7
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
FG007
Condition 8
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
FG008
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
FG009
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
FG010
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
FG011
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
FG012
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
FG013
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
FG014
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
FG015
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
FG0004 subjects
FG0015 subjects
FG0024 subjects
FG0034 subjects
FG0043 subjects
FG0054 subjects
FG0066 subjects
FG0074 subjects
FG0082 subjects
FG0095 subjects
FG0105 subjects
FG0115 subjects
FG0126 subjects
FG0137 subjects
FG0144 subjects
FG0154 subjects
COMPLETED
FG0004 subjects
FG0014 subjects
FG0023 subjects
FG0032 subjects
FG0043 subjects
FG0054 subjects
FG0066 subjects
FG0074 subjects
FG0081 subjects
FG0093 subjects
FG0103 subjects
FG0114 subjects
FG0126 subjects
FG0137 subjects
FG0144 subjects
FG0153 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0092 subjects
FG0102 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Baseline population included all randomized participants, N=72.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Condition 1
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
BG001
Condition 2
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
BG002
Condition 3
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
BG003
Condition 4
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
BG004
Condition 5
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
BG005
Condition 6
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
BG006
Condition 7
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
BG007
Condition 8
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
BG008
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
BG009
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
BG010
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
BG011
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
BG012
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
BG013
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
BG014
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
BG015
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
BG016
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0015
BG0024
BG0034
BG0043
BG0054
BG0066
BG0074
BG0082
BG0095
BG0105
BG0115
BG0126
BG0137
BG0144
BG0154
BG01672
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00034.2± 1.81
BG00134.1± 6.15
BG00229.2± 7.36
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Sex
Title
Measurements
Female
BG0004
BG0014
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Region of Enrollment
Number
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0004
BG0015
BG002
Weight (lb)
Weight was objectively measured at the participant's home. Participants were instructed to weigh themselves first thing in the morning, in light clothing, without shoes, at each assessment time point. Participants entered their weight in the study app and uploaded a picture of their feet on the scale with the number visible for verification.
Mean
Standard Deviation
pounds
Title
Denominators
Categories
Title
Measurements
BG000163.50± 24.61
BG001
Body Mass Index (BMI)
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00026.04± 6.88
BG00129.30± 9.29
BG002
Physical Activity (MVPA)
Objective moderate-to-vigorous physical activity (MVPA) measured via Fitbit
Mean
Standard Deviation
min/wk
Title
Denominators
Categories
Title
Measurements
BG000173.25± 37.69
BG001176.80± 247.80
Diet
Baseline Health Eating Index (HEI) score. HEI consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the Dietary Guidelines for Americans
Mean
Standard Deviation
Points
Title
Denominators
Categories
Title
Measurements
BG00046.55± 15.21
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Accrual Rate
Number of participants who agreed to participate divided by the number of months of recruitment.
Because this measure pertains to the study as a whole, the number of participants is not reported by arm.
Posted
Number
Participants per month
End of study enrollment period (7 months).
ID
Title
Description
OG000
Participants Recruited
All eligible participants who agreed to participate in the intervention.
Units
Counts
Participants
OG00083
Title
Denominators
Categories
Title
Measurements
OG00012
Primary
Participation Rate
Percentage of consented participants who were randomized.
Posted
Count of Participants
Participants
End of study enrollment period (7 months).
ID
Title
Description
OG000
Participants Recruited
All eligible participants who agreed to participate in the intervention.
Units
Counts
Participants
OG00083
Title
Denominators
Categories
Primary
Retention Rate
Number of intervention participants who completed 3-month measures divided by the number randomized to intervention arms.
Posted
Count of Participants
Participants
3 months
ID
Title
Description
OG000
Condition 1
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
OG001
Condition 2
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
OG002
Condition 3
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
OG003
Condition 4
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
OG004
Condition 5
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
Secondary
Acceptability: How Satisfied Are You Overall With the Program You Received?
1-item measure; a benchmark of 80% of participants answering "somewhat" or "very" satisfied would indicate acceptability
Among completers of the 12-week questionnaire
Posted
Count of Participants
Participants
3 months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach
OG002
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
Secondary
Adherence to Physical Activity Monitoring.
Number of days physical activity tracked, as measured by Fitbit.
Posted
Median
Inter-Quartile Range
Days
Through study completion, 3 months.
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Secondary
Adherence to Diet Self-monitoring
Number of days of complete dietary tracking.
Posted
Median
Inter-Quartile Range
Days
Through study completion, 3 months.
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
Estimated mean change in MVPA from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
ITT: all randomized participants using all available MVPA data.
Posted
Mean
95% Confidence Interval
min/wk
Baseline, 3 months.
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
Change in physical activity from baseline to 3 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses the amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. PA Activities were classified as light, moderate, and vigorous based on their metabolic equivalent (MET) value and commonly used cut points. Moderate and vigorous activities were combined for self-reported minutes per week of MVPA. Range is 0 - no theoretical maximum.
ITT: all randomized participants using all PPAQ data.
Posted
Mean
95% Confidence Interval
min/wk
Baseline, 3 months.
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Secondary
Dietary Intake: Healthy Eating Index (HEI)
Dietary intake will be defined as the change in HEI score as measured by the NCI's Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 3 months.The HEI consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the Dietary Guidelines for Americans. Estimated mean change in HEI from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
ITT: all randomized participants using all available ASA24 data.
Posted
Mean
99% Confidence Interval
Points
Baseline, 3 months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Secondary
Weight (kg)
Estimated mean weight change in kg from baseline to 3 months. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).
ITT: all randomized participants using all available weights.
Posted
Mean
95% Confidence Interval
pounds
Baseline, 3 months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
Secondary
Fried Physical Frailty : FRAIL Index
The FRAIL Questionnaire includes five components that assess: 1) self-reported fatigue (PROMIS Fatigue Short form), 2) weight loss, 3) comorbidities (11 items from University of North Carolina Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Physical Function Short Form), and 5) ability to overcome resistance (1 item from PROMIS Physical Function)). The number of positive responses for these components is summed to create the FRAIL index (range 0-5) and characterized as "Frailty Status"; 0-1: robust, 2: prefrail, and 3+: frail. Changes in Frailty Status from baseline to 3 months will be assessed.
All randomized were characterized by Frailty Status (Robust, Prefrail, Frail) at baseline and 3-months. At 3 months, NA = insufficient data for classification based on missing data.
Posted
Count of Participants
Participants
Baseline, 3 Months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Secondary
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. These measures assess relevant HRQoL domains for AYA cancer survivors that are most likely to be impacted during and after cancer treatment. The AYA PRO Core battery includes the following PROMIS short forms: depression, anxiety, fatigue, physical function, pain interference, emotional support, and cognitive function. For each measure, each question has five responses ranging in value from 1 to 5, which are summed to find the total raw score. Total raw scores are translated to a T-score, standardized with a population mean of 50 and a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured.
Participants who completed the PROMIS measures at 3 months.
Posted
Mean
Standard Deviation
T-score
Baseline, 3 months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Secondary
Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity)
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. Pain intensity was assessed with the 1-tiem PROMIS v1.0 pain intensity 1a, "In the past 7 days, how would you rate your pain on average?" Scored 0-10 from no pain to the worst imaginable pain.
Participants who completed the PROMIS measures at 3 months.
Posted
Mean
Standard Deviation
Score on scale
Baseline, 3 months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Secondary
Competence for Exercise and Nutrition
Changes in perceived competence from baseline to 3 months as measured using the Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence.
Participants who completed the Perceived Competence Scales for Nutrition and Diet at 3 months
Posted
Mean
Standard Deviation
Score on scale
Baseline, 3 months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Secondary
Self-efficacy for Exercise and Nutrition
Changes in self-efficacy from baseline to 3 months as measured using the Nutrition and Physical Activity Self-Efficacy Scale, a 10-items measured on a 4-point Likert scale that assesses an individual's confidence (where where 1 is 'very uncertain' to 4 'very certain') with in their ability to eat healthy foods (5 items) and exercise (5 items) in the presence of barriers. Self-efficacy for each behavior is calculated as the sum of the 5 Likert-type responses with a range of 5-20 for each subscale. Higher values indicate higher levels of self-efficacy for the behavior. Outcomes are changes in self-eficacy for exercise and self-efficacy for nutrition from baseline to 3 months.
Participants who completed the Self-efficacy Scale for Exercise and Diet at 3 months.
Posted
Mean
Standard Deviation
Score on scale
Baseline, 3 months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Secondary
Self-Regulation for Exercise and Nutrition
Changes in self-regulation from baseline to 3 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Ratings are on a 7-point Likert scale indicating agreement with statements regarding motivation for behavior change. Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for exercise and diet at 3 months.
Participants who completed the Treatment Self-Regulation Questionnaire (TSRQ) for Exercise and Diet at 3 months.
Posted
Mean
Standard Deviation
Score on scale
Baseline, 3 months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Secondary
Autonomy Support
Changes in perceived autonomy support from baseline to 3 months as measured using the Virtual Care Climate Questionnaire (VCCQ) a 15-item measure of perceived support for autonomy provided by the study team in a virtual care setting. Ratings are on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived autonomy support in a virtual setting.
Participants who completed the Virtual Care Climate Questionnaire (VCCQ) at 3 months.
Posted
Median
Standard Deviation
Score on scale
Baseline, 3 months
ID
Title
Description
OG000
Simplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
OG001
Simplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
OG002
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Time Frame
Up to 3 months
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Condition 1
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
0
4
0
4
3
4
EG001
Condition 2
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
0
5
0
5
4
5
EG002
Condition 3
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
0
4
1
4
0
4
EG003
Condition 4
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
0
4
0
4
3
4
EG004
Condition 5
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
0
3
0
3
2
3
EG005
Condition 6
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
0
4
0
4
1
4
EG006
Condition 7
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
0
6
0
6
1
6
EG007
Condition 8
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
0
4
0
4
2
4
EG008
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
0
2
0
2
1
2
EG009
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
0
5
0
5
3
5
EG010
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
0
5
0
5
3
5
EG011
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
0
5
0
5
3
5
EG012
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
0
6
0
6
3
6
EG013
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
0
7
0
7
4
7
EG014
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
0
4
0
4
1
4
EG015
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
0
4
0
4
4
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bowel Obstruction
Gastrointestinal disorders
Systematic Assessment
Hospitalized for 2 nights
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG0030 affected4 at risk
EG004
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Racing heartbeat
Cardiac disorders
Systematic Assessment
Resolved <24 hrs, no other detail provided
EG0000 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 affected4 at risk
EG0030 affected4 at risk
EG004
Low blood pressure
Cardiac disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
PVCs
Cardiac disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Motor vehicle accident
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 affected4 at risk
EG003
Throbbing back and hip pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
Related to motor vehicle accident
EG0000 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 affected4 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Tendonitis in shoulder
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Stress injury in tibia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Bruised/cracked rib from bronchitis
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Knee pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Headaches and neck pain
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pulled out lower back, neck, and shoulder pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
Due to walking around for an extended period of time at a music festival
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
OG006
Condition 7
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
OG007
Condition 8
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
OG008
Condition 9
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
OG009
Condition 10
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
OG010
Condition 11
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
OG011
Condition 12
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
OG012
Condition 13
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
OG013
Condition 14
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
OG014
Condition 15
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
OG015
Condition 16
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Units
Counts
Participants
OG0004
OG0015
OG0024
OG0034
OG0043
OG0054
OG0066
OG0074
OG0082
OG0095
OG0105
OG0115
OG0126
OG0137
OG0144
OG0154
Title
Denominators
Categories
Title
Measurements
OG0004
OG0014
OG0023
OG0032
OG0043
OG0054
OG0066
OG0074
OG0081
OG0093
OG0103
OG0114
OG0126
OG0137
OG0144
OG0153
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks.
Units
Counts
Participants
OG00030
OG00130
OG00224
OG00336
OG00431
OG00529
OG00630
OG00730
Title
Denominators
Categories
Title
Measurements
OG00024
OG00127
OG00220
OG00331
OG00426
OG00525
OG00625
OG00726
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks.
Units
Counts
Participants
OG00034
OG00138
OG00234
OG00338
OG00436
OG00536
OG00634
OG00738
Title
Denominators
Categories
Title
Measurements
OG00081.5± 21.0(65.8 to 84)
OG00170.8± 21.0(66.5 to 83)
OG00279± 25.1(51 to 83)
OG00383(77.2 to 84)
OG00483(73.2 to 84)
OG00579(58.8 to 83.2)
OG00681.5(76 to 83)
OG00783(60 to 84)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
Units
Counts
Participants
OG00034
OG00138
OG00234
OG00338
OG00436
OG00536
OG00634
OG00738
Title
Denominators
Categories
Title
Measurements
OG00043(19.5 to 60)
OG00149.5(17 to 61.5)
OG00239.5(9 to 60)
OG00352(27.2 to 59.8)
OG00452(27 to 69.2)
OG00535(8.5 to 57)
OG00648.5(27 to 60)
OG00744.5(6.75 to 60)
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
Units
Counts
Participants
OG00034
OG00138
OG00234
OG00338
OG00436
OG00536
OG00634
OG00738
Title
Denominators
Categories
Title
Measurements
OG00052.78(-36.06 to 141.62)
OG00170.12(-16.10 to 156.33)
OG00269.70(-24.96 to 164.35)
OG00353.20(-28.21 to 134.61)
OG00475.94(-13.61 to 165.48)
OG00546.96(-40.23 to 134.16)
OG00669.23(-20.61 to 159.06)
OG00753.67(-33.31 to 140.65)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Mixed Models Analysis
DF(2, 119)
0.02
The reported p-value reflects the change across time for the full sample.
Mean Difference (Net)
61.45
2-Sided
95
9.95
112.95
The positive parameter estimate indicates an increase in MVPA over time for the full sample.
Superiority
ITT analysis using linear mixed models comparing MVPA change over time (from baseline to 3 months). We fit a linear mixed model that included a random effect for participant and predictors (fixed effects) included time (baseline vs. follow-up) and all 4 factors.
OG000
OG001
ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of simplified dietary monitoring (green vs. red) on MVPA change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1, 69)
0.65
Mean Difference (Net)
21.36
2-Sided
95
-70.89
113.61
Green food monitoring (reference) vs red food monitoring; a positive estimation parameter indicates that the reference group had greater increases in MVPA over time.
Superiority
OG002
OG003
ITT analysis for factor 2 (dietary goals) using linear mixed models comparing the effect of dietary goals (yes vs. no) on MVPA change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,70)
0.20
Mean Difference (Net)
-60.05
2-Sided
95
-152.40
32.39
Nutrition goals (yes; reference) vs no goals provided; a negative estimation parameter indicates that the non-referent group had greater increases in MVPA over time.
Superiority
OG004
OG005
ITT analysis for factor 3 (supportive text messages) using linear mixed models comparing the effect of text messages (yes vs. no) on MVPA change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,70)
0.53
Mean Difference (Net)
29.52
2-Sided
95
-63.07
122.11
Supportive text messages (yes; reference) vs no text messages; a positive estimation parameter indicates that the reference group had greater increases in MVPA over time.
Superiority
OG006
OG007
ITT analysis for factor 4 (lesson delivery) using linear mixed models comparing the effect of lesson timing (once vs. weekly) on MVPA change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,70)
0.66
Mean Difference (Final Values)
-20.5
2-Sided
95
-113.26
72.27
Lesson delivery once (reference) vs weekly; a negative estimation parameter indicates that the non-referent group had greater increases in MVPA over time.
Superiority
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
Units
Counts
Participants
OG00034
OG00138
OG00234
OG00338
OG00436
OG00536
OG00634
OG00738
Title
Denominators
Categories
Title
Measurements
OG00055.60(3.13 to 108.07)
OG00134.13(-17.03 to 85.29)
OG00250.97(-4.77 to 106.71)
OG00338.76(-9.53 to 87.05)
OG00447.36(-3.83 to 98.55)
OG00542.37(-10.18 to 94.92)
OG00658.67(5.67 to 111.68)
OG00731.06(-19.70 to 81.81)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Mixed Models Analysis
DF(2,127)
0.004
Mean Difference (Net)
44.87
2-Sided
95
14.39
75.43
The positive parameter estimate indicates an increase in self-reported MVPA over time for the full sample.
Superiority
ITT analysis using linear mixed models comparing self-reported MVPA change over time (from baseline to 3 months). We fit a linear mixed model that included a random effect for participant and predictors (fixed effects) included time (baseline vs. follow-up) and all 4 factors.
OG000
OG001
ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of simplified dietary monitoring (green vs. red) on self-reported MVPA change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,72)
0.47
Mean Difference (Net)
-15.32
2-Sided
95
-58.96
28.32
Green food monitoring (reference) vs red food monitoring; a negative estimation parameter indicates that the non-referent group had greater increases in MVPA over time.
Superiority
OG002
OG003
ITT analysis for factor 2 (dietary goals) using linear mixed models comparing the effect of dietary goals (yes vs. no) on self-reported MVPA change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,73)
0.47
Mean Difference (Net)
16.02
2-Sided
95
-27.67
59.7
Nutrition goals (yes; reference) vs no goals provided; a positive estimation parameter indicates that the reference group had greater increases in self-reported MVPA over time.
Superiority
OG004
OG005
ITT analysis for factor 3 (supportive text messages) using linear mixed models comparing the effect of text messages (yes vs. no) on self-reported MVPA change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,71)
0.66
Mean Difference (Net)
9.72
2-Sided
95
-34.09
53.52
Supportive text messages (yes; reference) vs no text messages; a positive estimation parameter indicates that the reference group had greater increases in self-reported MVPA over time.
Superiority
OG006
OG007
ITT analysis for factor 4 (lesson delivery) using linear mixed models comparing the effect of lesson timing (once vs. weekly) on self-reported MVPA change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,72)
0.06
Mean Difference (Net)
-42.15
2-Sided
95
-86.04
1.73
Lesson delivery once (reference) vs weekly; a negative estimation parameter indicates that the non-referent group had greater increases in self-reported MVPA over time.
Superiority
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
Units
Counts
Participants
OG00034
OG00138
OG00234
OG00338
OG00436
OG00536
OG00634
OG00738
Title
Denominators
Categories
Title
Measurements
OG0004.66(0.29 to 9.02)
OG0010.32(-4.01 to 4.64)
OG0024.65(-0.05 to 9.35)
OG0030.32(-3.69 to 4.34)
OG0041.85(-2.39 to 6.09)
OG0053.13(-1.36 to 7.61)
OG0063.38(-1.04 to 7.80)
OG0071.59(-2.71 to 5.90)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
ITT analysis using linear mixed models comparing HEI score change over time (from baseline to 3 months). We fit a linear mixed model that included a random effect for participant and predictors (fixed effects) included time (baseline vs. follow-up) and all 4 factors.
Mixed Models Analysis
DF(1,61)
0.109
Mean Difference (Net)
2.49
2-Sided
95
-0.56
5.54
The positive parameter estimate indicates an increase in HEI score over time for the full sample.
Superiority
OG000
OG001
ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of simplified dietary monitoring (green vs. red) on HEI score change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,68)
0.71
Mean Difference (Net)
-1.17
2-Sided
95
-7.42
5.08
Green food monitoring (reference) vs red food monitoring; a negative estimation parameter indicates that the non-referent group had greater increases in HEI score.
Superiority
OG002
OG003
ITT analysis for factor 2 (dietary goals) using linear mixed models comparing the effect of dietary goals (yes vs. no) on HEI score change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,68)
0.89
Mean Difference (Net)
0.44
2-Sided
95
-5.82
6.69
Nutrition goals (yes; reference) vs no goals provided; a positive estimation parameter indicates that the reference group had greater increases in HEI score over time.
Superiority
OG004
OG005
ITT analysis for factor 3 (supportive text messages) using linear mixed models comparing the effect of text messages (yes vs. no) on HEI score change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,68)
0.25
Mean Difference (Net)
3.66
2-Sided
95
-2.61
9.93
Supportive text messages (yes; reference) vs no text messages; a positive estimation parameter indicates that the reference group had greater increases in HEI score over time.
Superiority
OG006
OG007
ITT analysis for factor 4 (lesson delivery) using linear mixed models comparing the effect of lesson timing (once vs. weekly) on HEI score change over time (from baseline to 3 months).
Mixed Models Analysis
DF(1,68)
0.57
Mean Difference (Net)
-1.83
2-Sided
95
-8.11
4.45
Lesson delivery once (reference) vs weekly; a negative estimation parameter indicates that the non-referent group had greater increases in HEI score over time.
Superiority
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
Units
Counts
Participants
OG00034
OG00138
OG00234
OG00338
OG00436
OG00536
OG00634
OG00738
Title
Denominators
Categories
Title
Measurements
OG000-1.47(-3.44 to 0.51)
OG001-2.39(-4.38 to -0.40)
OG002-1.26(-3.40 to 0.87)
OG003-2.60(-4.43 to -0.76)
OG004-2.32(-4.27 to -0.36)
OG005-1.54(-3.56 to 0.48)
OG006-2.23(-4.28 to -0.18)
OG007-1.63(-3.55 to 0.29)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
Units
Counts
Participants
OG00034
OG00138
OG00234
OG00338
OG00436
OG00536
OG00634
OG00738
Title
Denominators
Categories
Baseline Frailty Status
Title
Measurements
Robust
OG00034
OG00134
OG00232
OG00336
OG00435
OG00533
OG00632
OG00736
Prefrail
OG0000
OG0011
OG0020
OG0031
OG004
Frail
OG0000
OG0013
OG0022
OG0031
OG004
NA
OG0000
OG0010
OG0020
OG0030
OG004
3-Month Frailty Status
Title
Measurements
Robust
OG00029
OG00125
OG00222
OG003
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
OG008
All Participants
All randomized participants
Units
Counts
Participants
OG00030
OG00131
OG00224
OG00337
OG00432
OG00529
OG00630
OG00731
OG00861
Title
Denominators
Categories
Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a)
Title
Measurements
OG0001.68± 9.19
OG001-1.85± 5.83
OG0021.72± 9.87
OG003-1.3± 5.97
OG0041.75± 9.01
OG005-2.17± 5.68
OG006-1.70± 7.71
OG0071.42± 7.71
OG008-0.11± 7.81
Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a)
Title
Measurements
OG000-1.50± 7.53
OG001-1.14± 7.95
OG002-0.83± 9.24
OG003
Fatigue (PROMIS v1.0-Fatigue Short form 4a)
Title
Measurements
OG000-4.26± 9.64
OG001-0.65± 9.08
OG002-3.28± 7.34
OG003
Physical Function (PROMIS v2.0 Physical Function Short Form 4a)
Title
Measurements
OG0001.08± 5.29
OG0010.60± 6.79
OG002-0.86± 6.28
OG003
Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a)
Title
Measurements
OG0003.37± 6.12
OG0012.65± 6.19
OG0023.30± 5.45
OG003
Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a)
Title
Measurements
OG000-2.06± 6.22
OG001-0.003± 5.57
OG002-1.33± 6.05
OG003
Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a)
Title
Measurements
OG0002.86± 8.67
OG0011.48± 6.30
OG0023.30± 7.56
OG003
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
OG008
All Participants
All randomized participants
Units
Counts
Participants
OG00030
OG00131
OG00224
OG00337
OG00432
OG00529
OG00630
OG00731
OG00861
Title
Denominators
Categories
Title
Measurements
OG0000.7± 2.12
OG0010.36± 1.33
OG0020.54± 1.47
OG0030.51± 1.94
OG0040.44± 1.54
OG0050.62± 1.99
OG0060.37± 1.81
OG0070.68± 1.72
OG0080.53± 1.76
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
OG008
All Participants
All randomized participants
Units
Counts
Participants
OG00030
OG00131
OG00224
OG00337
OG00432
OG00529
OG00630
OG00731
OG00861
Title
Denominators
Categories
Perceived Competence for Exercise
Title
Measurements
OG0000.6± 6.15
OG001-1.61± 4.09
OG002-1.38± 5.52
OG0030.027± 5.12
OG004-1.28± 5.13
OG0050.31± 5.41
OG0060.9± 5.51
OG007-1.90± 4.74
OG008-0.53± 5.28
Perceived Competence for Nutrition
Title
Measurements
OG0001.13± 4.49
OG001-0.03± 2.98
OG0020.54± 4.53
OG003
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
OG008
All Participants
All randomized participants
Units
Counts
Participants
OG00030
OG00131
OG00224
OG00337
OG00432
OG00529
OG00630
OG00731
OG00861
Title
Denominators
Categories
Self-efficacy for Exercise
Title
Measurements
OG000-0.3± 3.80
OG0010.06± 2.46
OG0020.58± 3.71
OG003-0.57± 2.72
OG0040± 3.34
OG005-0.24± 3.02
OG006-0.27± 2.72
OG0070.03± 3.59
OG008-0.12± 3.17
Self-efficacy for Nutrition
Title
Measurements
OG0000.73± 2.94
OG0010.39± 2.53
OG0020.71± 2.74
OG003
OG002
Nutrition Goals (Yes)
Participants will be assigned a personalized weekly nutrition goal related to the nutrition monitoring condition.
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks
OG008
All Participants
All randomized participants
Units
Counts
Participants
OG00030
OG00131
OG00224
OG00337
OG00432
OG00529
OG00630
OG00731
OG00861
Title
Denominators
Categories
Autonomous Motivation for Exercise
Title
Measurements
OG000-0.06± 0.85
OG001-0.09± 0.761
OG002-0.17± 0.87
OG003-0.014± 0.76
OG0040.04± 0.88
OG005-0.20± 0.70
OG006-0.04± 0.76
OG007-0.11± 0.85
OG008-0.07± 0.80
Autonomous Motivation for Diet
Title
Measurements
OG000-0.07± 0.88
OG0010.02± 0.71
OG002-0.11± 0.89
OG003
Externally Controlled Motivation for Exercise
Title
Measurements
OG000-0.01± 0.61
OG0010.38± 1.05
OG0020.05± 1.04
OG003
Externally Controlled Motivation for Diet
Title
Measurements
OG0000± 0.96
OG0010.27± 0.95
OG002-0.13± 0.89
OG003
Nutrition Goals (No)
Participants will not be assigned a personalized weekly nutrition goal.
OG004
Supportive Text Messages (Yes)
Participants will receive up to 5 supportive text messages from the study staff per week.
OG005
Supportive Text Messages (No)
Participants will not receive supportive text messages.
OG006
Lesson Delivery (Once)
All behavioral lessons will be made available to participants simultaneously at the beginning of the intervention.
OG007
Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participants weekly throughout the 12 weeks