Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
Official Title
Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
Acronym
Opt-IN
Organization
Northwestern UniversityOTHER
Status Module
Record Verification Date
Jan 2023
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
Sep 2013
Primary Completion Date
Sep 20, 2017Actual
Completion Date
Sep 20, 2017Actual
First Submitted Date
Mar 15, 2013
First Submission Date that Met QC Criteria
Mar 15, 2013
First Posted Date
Mar 19, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 9, 2020
Results First Submitted that Met QC Criteria
Dec 9, 2020
Results First Posted Date
Jan 5, 2021Actual
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
Jan 12, 2023
Last Update Posted Date
Feb 1, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Bonnie Spring, Professor, Northwestern UniversityPrincipal Investigator
Lead Sponsor
Northwestern UniversityOTHER
Collaborators
Name
Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Penn State University
OTHER
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 overall objective of the proposed research is to use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI) for obesity. MOST involves highly efficient randomized experimentation to assess the effects of individual treatment components, and thereby identify which components and component levels make important contributions to the overall program effect on weight loss. This information then guides assembly of an optimized treatment package that achieves target outcomes with least resource consumption and participant burden. Because the intervention strategies being tested minimize in-person coaching and leverage technology that participants already own, the new optimized intervention, to be called Opt-IN, will be more scalable than traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant progress in the fight against obesity.
Detailed Description
The goal of the proposed study is to determine the optimal composition of a technology supported intervention for obesity that minimizes expense and burden to participants, while achieving 6 month weight loss outcomes comparable or superior to those achieved by the current full cost, full burden form of INLIs. All intervention components to be examined were selected based on the Opt-IN model's prediction that they enhance behavioral adherence to weight regulation via the designated pathways. The five components to be tested will be: (1) coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive (No vs. Yes).
Conditions Module
Conditions
Weight Loss
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
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
562Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Condition 1
Experimental
1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Condition 2
Experimental
1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Recommendations to use meal replacements
Behavioral: Buddy Training
Condition 3
Experimental
1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Text Messages
Behavioral: Buddy Training
Condition 4
Experimental
1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Text Messages
Behavioral: Recommendations to use meal replacements
Interventions
Name
Type
Description
Arm Group Labels
Other Names
12 Telephone Coaching Sessions
Behavioral
Participants will receive 12 telephone coaching sessions
Condition 1
Condition 17
Condition 18
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Weight Change (kg) From Baseline to Month 6, Main Effect of Time
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
From Baseline to Month 6
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).
From Baseline to Month 6
Secondary Outcomes
Measure
Description
Time Frame
Intervention for <$500
Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.
6 months
Other Outcomes
Measure
Description
Time Frame
Treatment Adherence
Treatment adherence is a hypothesized mediator that will be operationalized as the number of treatment sessions completed divided by the number of treatment sessions offered (12 or 24)
6 months
Self-monitoring Adherence
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
18 and 60 years old
BMI 25-40 kg/m2
Weight stable (no loss or gain >25 lbs for the past 6 months)
Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight.
Own a Smartphone and be willing to install the Opt-IN app
Able to use the app to record dietary intake and weight onto the Smartphone
"Buddy" participants must:
18 years of age or older
Have access to a computer and internet
Be willing to undergo "Buddy Training" and participate in 4 webinars
Be willing to provide support and encouragement to the participant
Exclusion Criteria:
Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
Use an assistive device for mobility (e.g., wheelchair, walker, cane)
Plantar fasciitis
Hospitalization for a psychiatric disorder within the past 5 years
At risk for adverse cardiovascular (CVD) events with moderate intensity activity
Cannot read the study questionnaires
Committed to following an incompatible dietary regimen
Not be pregnant, trying to get pregnant, or lactating
Bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) or report active suicidal ideation
Low motivation to change
Cannot live with a current or past Opt-IN participant
Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.
Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants who signed an informed consent were invited to attend a baseline assessment where they were screened further for entry and exclusion criteria. Baseline data was gathered. Participants who continued to be eligible were scheduled for the randomization session where they learned their study assignment.
Recruitment Details
8593 were screened. 1159 attended orientation. 1078 signed consent. 562 were randomized.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
1. 12 Calls, PCP
Participant's received biweekly (12) coaching calls, and PCP Reports
FG001
2. 12 Calls, PCP, MR, Buddy
Participant's received biweekly (12) coaching calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training.
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
5
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
Dec 20, 2018
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
No data available
No data is available for this block.
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Condition 5
Experimental
1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Buddy Training
Condition 6
Experimental
1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Recommendations to use meal replacements
1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Text Messages
Behavioral: Recommendations to use meal replacements
Behavioral: Buddy Training
Condition 9
Experimental
1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Condition 10
Experimental
1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Recommendations to use meal replacements
Behavioral: Buddy Training
Condition 11
Experimental
1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Text Messages
Behavioral: Buddy Training
Condition 12
Experimental
1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Text Messages
Behavioral: Recommendations to use meal replacements
Condition 13
Experimental
1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Buddy Training
Condition 14
Experimental
1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Recommendations to use meal replacements
1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Recommendations to use meal replacements
Behavioral: Buddy Training
Condition 19
Experimental
1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Text Messages
Behavioral: Buddy Training
Condition 20
Experimental
1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Text Messages
Behavioral: Recommendations to use meal replacements
Condition 21
Experimental
1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
Behavioral: Report to Primary Care Physician
Behavioral: Buddy Training
Condition 22
Experimental
1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements
Behavioral: Report to Primary Care Physician
Condition 23
Experimental
1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Text Messages
Condition 24
Experimental
1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
Behavioral: 12 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Text Messages
Behavioral: Recommendations to use meal replacements
1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Recommendations to use meal replacements
Behavioral: Buddy Training
Condition 27
Experimental
1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Text Messages
Behavioral: Buddy Training
Condition 28
Experimental
1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Text Messages
Behavioral: Recommendations to use meal replacements
Condition 29
Experimental
1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Buddy Training
Condition 30
Experimental
1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Recommendations to use meal replacements
Condition 31
Experimental
1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Text Messages
Condition 32
Experimental
1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
Behavioral: 24 Telephone Coaching Sessions
Behavioral: Report to Primary Care Physician
Behavioral: Text Messages
Behavioral: Recommendations to use meal replacements
Behavioral: Buddy Training
Condition 19
Condition 2
Condition 20
Condition 23
Condition 24
Condition 3
Condition 4
Condition 5
Condition 6
Condition 7
Condition 8
24 Telephone Coaching Sessions
Behavioral
Participants will receive 24 telephone coaching sessions
Condition 10
Condition 11
Condition 12
Condition 13
Condition 14
Condition 15
Condition 16
Condition 25
Condition 26
Condition 27
Condition 28
Condition 29
Condition 30
Condition 31
Condition 32
Condition 9
Report to Primary Care Physician
Behavioral
Participants will have a report detailing their weight loss progress sent to their primary care physician
Condition 1
Condition 10
Condition 11
Condition 12
Condition 2
Condition 21
Condition 22
Condition 23
Condition 24
Condition 29
Condition 3
Condition 30
Condition 31
Condition 32
Condition 4
Condition 9
Text Messages
Behavioral
Participants will receive regular text messages
Condition 11
Condition 12
Condition 15
Condition 16
Condition 19
Condition 20
Condition 23
Condition 24
Condition 27
Condition 28
Condition 3
Condition 31
Condition 32
Condition 4
Condition 7
Condition 8
Recommendations to use meal replacements
Behavioral
Participants will receive recommendations from their coach to use meal replacements
Condition 10
Condition 12
Condition 14
Condition 16
Condition 18
Condition 2
Condition 20
Condition 24
Condition 26
Condition 28
Condition 30
Condition 32
Condition 4
Condition 6
Condition 8
Buddy Training
Behavioral
Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 10
Condition 11
Condition 13
Condition 16
Condition 18
Condition 19
Condition 2
Condition 21
Condition 24
Condition 26
Condition 27
Condition 29
Condition 3
Condition 32
Condition 5
Condition 8
Self-monitoring is a hypothesized mediator that will be operationalized as the number of days recording weight, dietary intake, and physical activity
6 months
Self-efficacy
Self-efficacy is an exploratory mediator that will be assessed to examine treatment effects on confidence about performing two categories of behaviors associated with weight loss: diet and physical activity
6 months
Self-Regulation
Self-regulation is an exploratory mediator that will be assessed using the Three Factor Eating Questionnaire and Treatment Self-Regulation Questionnaire
6 months
Supportive Accountability
Supportive accountability is an exploratory mediator that will be measured by assessing two constructs that define supportive accountability: therapeutic alliance and perceived autonomy support
6 months
Facilitation
Facilitation is an exploratory mediator that will be measured by rating how much the tools provided by the study have changed their environment and by the Weight Management Support Inventory
Pfammatter AF, Nahum-Shani I, DeZelar M, Scanlan L, McFadden HG, Siddique J, Hedeker D, Spring B. SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management. Contemp Clin Trials. 2019 Jul;82:36-45. doi: 10.1016/j.cct.2019.05.007. Epub 2019 May 23.
Terry PE, Brown N, Arnett DK, Cushman M, Spring B, Halpern SD, Burke LE, Grossmeier J, Goetzel R, Lang J, Calitz C, Terry PE, Sanchez E. The Art of Health Promotion ideas for improving health outcomes. Am J Health Promot. 2016 Sep;30(7):563-82. doi: 10.1177/0890117116668866. No abstract available.
Pellegrini CA, Conroy DE, Phillips SM, Pfammatter AF, McFadden HG, Spring B. Daily and Seasonal Influences on Dietary Self-monitoring Using a Smartphone Application. J Nutr Educ Behav. 2018 Jan;50(1):56-61.e1. doi: 10.1016/j.jneb.2016.12.004.
Welch WA, Spring B, Phillips SM, Siddique J. Moderating Effects of Weather-Related Factors on a Physical Activity Intervention. Am J Prev Med. 2018 May;54(5):e83-e89. doi: 10.1016/j.amepre.2018.01.025. Epub 2018 Mar 15.
Burke LE, Ma J, Azar KM, Bennett GG, Peterson ED, Zheng Y, Riley W, Stephens J, Shah SH, Suffoletto B, Turan TN, Spring B, Steinberger J, Quinn CC; American Heart Association Publications Committee of the Council on Epidemiology and Prevention, Behavior Change Committee of the Council on Cardiometabolic Health, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, Council on Quality of Care and Outcomes Research, and Stroke Council. Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2015 Sep 22;132(12):1157-213. doi: 10.1161/CIR.0000000000000232. Epub 2015 Aug 13. No abstract available.
Booth JN 3rd, Allen NB, Calhoun D, Carson AP, Deng L, Goff DC Jr, Redden DT, Reis JP, Shimbo D, Shikany JM, Sidney S, Spring B, Lewis CE, Muntner P. Racial Differences in Maintaining Optimal Health Behaviors Into Middle Age. Am J Prev Med. 2019 Mar;56(3):368-375. doi: 10.1016/j.amepre.2018.10.020.
Spring B, Pfammatter A, Alshurafa N. First Steps Into the Brave New Transdiscipline of Mobile Health. JAMA Cardiol. 2017 Jan 1;2(1):76-78. doi: 10.1001/jamacardio.2016.4440. No abstract available.
Hoffman SA, Ledford G, Cameron KA, Phillips SM, Pellegrini CA. A qualitative exploration of social and environmental factors affecting diet and activity in knee replacement patients. J Clin Nurs. 2019 Apr;28(7-8):1156-1163. doi: 10.1111/jocn.14719. Epub 2018 Dec 10.
Hekler EB, Michie S, Pavel M, Rivera DE, Collins LM, Jimison HB, Garnett C, Parral S, Spruijt-Metz D. Advancing Models and Theories for Digital Behavior Change Interventions. Am J Prev Med. 2016 Nov;51(5):825-832. doi: 10.1016/j.amepre.2016.06.013.
Collins LM, Kugler KC, Gwadz MV. Optimization of Multicomponent Behavioral and Biobehavioral Interventions for the Prevention and Treatment of HIV/AIDS. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S197-214. doi: 10.1007/s10461-015-1145-4.
Spring B, Pellegrini CA, Pfammatter A, Duncan JM, Pictor A, McFadden HG, Siddique J, Hedeker D. Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial. Obesity (Silver Spring). 2017 Jul;25(7):1191-1198. doi: 10.1002/oby.21842. Epub 2017 May 11.
Pellegrini CA, Pfammatter AF, Conroy DE, Spring B. Smartphone applications to support weight loss: current perspectives. Adv Health Care Technol. 2015 Jul;1:13-22. doi: 10.2147/AHCT.S57844.
Spring B, Ockene JK, Gidding SS, Mozaffarian D, Moore S, Rosal MC, Brown MD, Vafiadis DK, Cohen DL, Burke LE, Lloyd-Jones D; American Heart Association Behavior Change Committee of the Council on Epidemiology and Prevention, Council on Lifestyle and Cardiometabolic Health, Council for High Blood Pressure Research, and Council on Cardiovascular and Stroke Nursing. Better population health through behavior change in adults: a call to action. Circulation. 2013 Nov 5;128(19):2169-76. doi: 10.1161/01.cir.0000435173.25936.e1. Epub 2013 Oct 7. No abstract available.
Pellegrini CA, Hoffman SA, Daly ER, Murillo M, Iakovlev G, Spring B. Acceptability of smartphone technology to interrupt sedentary time in adults with diabetes. Transl Behav Med. 2015 Sep;5(3):307-14. doi: 10.1007/s13142-015-0314-3.
Watkins E, Newbold A, Tester-Jones M, Javaid M, Cadman J, Collins LM, Graham J, Mostazir M. Implementing multifactorial psychotherapy research in online virtual environments (IMPROVE-2): study protocol for a phase III trial of the MOST randomized component selection method for internet cognitive-behavioural therapy for depression. BMC Psychiatry. 2016 Oct 6;16(1):345. doi: 10.1186/s12888-016-1054-8.
Collins LM, Nahum-Shani I, Almirall D. Optimization of behavioral dynamic treatment regimens based on the sequential, multiple assignment, randomized trial (SMART). Clin Trials. 2014 Aug;11(4):426-434. doi: 10.1177/1740774514536795. Epub 2014 Jun 5.
Pellegrini CA, Hoffman SA, Collins LM, Spring B. Optimization of remotely delivered intensive lifestyle treatment for obesity using the Multiphase Optimization Strategy: Opt-IN study protocol. Contemp Clin Trials. 2014 Jul;38(2):251-9. doi: 10.1016/j.cct.2014.05.007. Epub 2014 May 17.
Pellegrini CA, Hoffman SA, Collins LM, Spring B. Corrigendum to "Optimization of remotely delivered intensive lifestyle treatment for obesity using the Multiphase Optimization Strategy: Opt-IN study protocol" [Contemp. Clin. Trials 38 (2014) 251-259]. Contemp Clin Trials. 2015 Nov;45(Pt B):468-469. doi: 10.1016/j.cct.2015.09.001. Epub 2015 Nov 29. No abstract available.
Pfammatter AF, Marchese SH, Pellegrini C, Daly E, Davidson M, Spring B. Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research. JMIR Form Res. 2020 May 13;4(5):e16297. doi: 10.2196/16297.
FG002
3. 12 Calls, PCP, Texts, Buddy
Participant received 12 calls, PCP Reports, Texts, and Buddy Training
FG003
4. 12 Calls, PCP, Texts, MR
Participant received 12 calls, PCP Reports, Texts, and Meal Replacement Recommendations
FG004
5. 12 Calls, Buddy
Participant received 12 calls, and Buddy Training
FG005
6. 12 Calls, MR
Participant received 12 calls, and Meal Replacement Recommendations
FG006
7. 12 Calls, Texts
Participant received 12 calls, and Texts
FG007
8. 12 Calls, Texts, MR, Buddy
Participant received 12 calls, Texts, Meal Replacement Recommendations, and Buddy Training
FG008
9. 24 Calls, PCP
Participants received 24 calls, and PCP Reports
FG009
10. 24 Calls, PCP, MR, Buddy
Participants received 24 calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training
FG010
11. 24 Calls, PCP, Texts, Buddy
Participants received 24 calls, PCP Reports, Texts, and Buddy Training
FG011
12. 24 Calls, PCP, Texts, MR
Participants received 24 calls, PCP Reports, Texts, and Meal Replacement Recommendations
FG012
13. 24 Calls, Buddy
Participants received 24 calls, and Buddy Training
FG013
14. 24 Calls, MR
Participants received 24 calls, and Meal Replacement Recommendations
FG014
15. 24 Calls, Texts
Participants received 24 calls, and Texts
FG015
16. 24 Calls, Texts, MR, Buddy
Participants received 24 calls, Texts, Meal Replacement Recommendations, and Buddy Training
FG016
17. 12 Calls
Participants received 12 calls
FG017
18. 12 Calls, MR, Buddy
Participants received 12 calls, Meal Replacement Recommendations, and Buddy Training
FG018
19. 12 Calls, Texts, Buddy
Participants received 12 calls, Texts, and Buddy Training
FG019
20. 12 Calls, Texts, MR
Participants received 12 calls, Texts, Meal Replacement Recommendations
FG020
21. 12 Calls, PCP, Buddy
Participants received 12 calls, PCP Reports, and Buddy Training
FG021
22. 12 Calls, PCP, MR
Participants received 12 calls, PCP Reports, and Meal Replacement Recommendations
FG022
23. 12 Calls PCP, Texts
Participants received 12 calls, PCP Reports, and Texts
FG023
24. 12 Calls, PCP, Texts, MR, Buddy
Participants received 12 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
FG024
25. 24 Calls
Participants received 24 calls
FG025
26. 24 Calls, MR, Buddy
Participants received 24 calls, Meal Replacement Recommendations, and Buddy Training
FG026
27. 24 Calls, Texts, Buddy
Participants received 24 calls, Texts, and Buddy Training
FG027
28. 24 Calls, Texts, MR
Participants received 24 calls, Texts, and Meal Replacement Recommendations
FG028
29. 24 Calls, PCP, Buddy
Participants received 24 calls, PCP Reports, and Buddy Training
FG029
30. 24 Calls, PCP, MR
Participants received 24 calls, PCP Reports, and Meal Replacement Recommendations
FG030
31. 24 Calls, PCP, Texts
Participants received 24 calls, PCP Reports, and Texts
FG031
32. 24 Calls, PCP, Texts, MR, Buddy
Participants received 24 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
FG00018 subjects
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3-mo Visit
FG00015 subjects
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FG00216 subjects
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FG00616 subjects
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FG01516 subjects
FG01616 subjects
FG01716 subjects
FG01814 subjects
FG01913 subjects
FG02015 subjects
FG02117 subjects
FG02215 subjects
FG02318 subjects
FG02413 subjects
FG02514 subjects
FG02617 subjects
FG02714 subjects
FG02815 subjects
FG02916 subjects
FG03016 subjects
FG03117 subjects
Intent to Treat
FG0004 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG0044 subjects
FG0056 subjects
FG0064 subjects
FG0071 subjects
FG0083 subjects
FG0095 subjects
FG0101 subjects
FG0112 subjects
FG0123 subjects
FG0132 subjects
FG0143 subjects
FG0152 subjects
FG0163 subjects
FG0171 subjects
FG0183 subjects
FG0195 subjects
FG0202 subjects
FG0211 subjects
FG0224 subjects
FG0231 subjects
FG0246 subjects
FG0252 subjects
FG0262 subjects
FG0274 subjects
FG0284 subjects
FG0293 subjects
FG0302 subjects
FG0310 subjects
COMPLETED
FG00014 subjects
FG00116 subjects
FG00215 subjects
FG00318 subjects
FG00414 subjects
FG00512 subjects
FG00614 subjects
FG00717 subjects
FG00816 subjects
FG00913 subjects
FG01017 subjects
FG01116 subjects
FG01215 subjects
FG01316 subjects
FG01415 subjects
FG01516 subjects
FG01614 subjects
FG01717 subjects
FG01814 subjects
FG01911 subjects
FG02014 subjects
FG02116 subjects
FG02213 subjects
FG02317 subjects
FG02411 subjects
FG02514 subjects
FG02616 subjects
FG02713 subjects
FG02814 subjects
FG02914 subjects
FG03015 subjects
FG03117 subjects
NOT COMPLETED
FG0004 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG0044 subjects
FG0056 subjects
FG0064 subjects
FG0071 subjects
FG0083 subjects
FG0095 subjects
FG0101 subjects
FG0112 subjects
FG0123 subjects
FG0132 subjects
FG0143 subjects
FG0152 subjects
FG0163 subjects
FG0171 subjects
FG0183 subjects
FG0195 subjects
FG0202 subjects
FG0211 subjects
FG0224 subjects
FG0231 subjects
FG0246 subjects
FG0252 subjects
FG0262 subjects
FG0274 subjects
FG0284 subjects
FG0293 subjects
FG0302 subjects
FG0310 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG0042 subjects
FG0053 subjects
FG0063 subjects
FG0071 subjects
FG0082 subjects
FG0093 subjects
FG0101 subjects
FG0112 subjects
FG0122 subjects
FG0131 subjects
FG0142 subjects
FG0151 subjects
FG0163 subjects
FG0171 subjects
FG0183 subjects
FG0193 subjects
FG0202 subjects
FG0211 subjects
FG0223 subjects
FG0231 subjects
FG0244 subjects
FG0251 subjects
FG0261 subjects
FG0272 subjects
FG0283 subjects
FG0293 subjects
FG0302 subjects
FG0310 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Baseline population included all randomized participants (562).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
1. 12 Calls, PCP
Participants received biweekly (12) coaching calls, and PCP Reports
BG001
2. 12 Calls, PCP, MR, Buddy
Participants received biweekly (12) coaching calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training.
BG002
3. 12 Calls, PCP, Texts, Buddy
Participants received 12 calls, PCP Reports, Texts, and Buddy Training
BG003
4. 12 Calls, PCP, Texts, MR
Participants received 12 calls, PCP Reports, Texts, and Meal Replacement Recommendations
BG004
5. 12 Calls, Buddy
Participants received 12 calls, and Buddy Training
BG005
6. 12 Calls, MR
Participants received 12 calls, and Meal Replacement Recommendations
BG006
7. 12 Calls, Texts
Participants received 12 calls, and Texts
BG007
8. 12 Calls, Texts, MR, Buddy
Participants received 12 calls, Texts, Meal Replacement Recommendations, and Buddy Training
BG008
9. 24 Calls, PCP
Participants received 24 calls, and PCP Reports
BG009
10. 24 Calls, PCP, MR, Buddy
Participants received 24 calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training
BG010
11. 24 Calls, PCP, Texts, Buddy
Participants received 24 calls, PCP Reports, Texts, and Buddy Training
BG011
12. 24 Calls, PCP, Texts, MR
Participants received 24 calls, PCP Reports, Texts, and Meal Replacement Recommendations
BG012
13. 24 Calls, Buddy
Participants received 24 calls, and Buddy Training
BG013
14. 24 Calls, MR
Participants received 24 calls, and Meal Replacement Recommendations
BG014
15. 24 Calls, Texts
Participants received 24 calls, and Texts
BG015
16. 24 Calls, Texts, MR, Buddy
Participants received 24 calls, Texts, Meal Replacement Recommendations, and Buddy Training
BG016
17. 12 Calls
Participants received 12 calls
BG017
18. 12 Calls, MR, Buddy
Participants received 12 calls, Meal Replacement Recommendations, and Buddy Training
BG018
19. 12 Calls, Texts, Buddy
Participants received 12 calls, Texts, and Buddy Training
BG019
20. 12 Calls, Texts, MR
Participants received 12 calls, Texts, Meal Replacement Recommendations
BG020
21. 12 Calls, PCP, Buddy
Participants received 12 calls, PCP Reports, and Buddy Training
BG021
22. 12 Calls, PCP, MR
Participants received 12 calls, PCP Reports, and Meal Replacement Recommendations
BG022
23. 12 Calls PCP, Texts
Participants received 12 calls, PCP Reports, and Texts
BG023
24. 12 Calls, PCP, Texts, MR, Buddy
Participants received 12 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
BG024
25. 24 Calls
Participants received 24 calls
BG025
26. 24 Calls, MR, Buddy
Participants received 24 calls, Meal Replacement Recommendations, and Buddy Training
BG026
27. 24 Calls, Texts, Buddy
Participants received 24 calls, Texts, and Buddy Training
BG027
28. 24 Calls, Texts, MR
Participants received 24 calls, Texts, and Meal Replacement Recommendations
BG028
29. 24 Calls, PCP, Buddy
Participants received 24 calls, PCP Reports, and Buddy Training
BG029
30. 24 Calls, PCP, MR
Participants received 24 calls, PCP Reports, and Meal Replacement Recommendations
BG030
31. 24 Calls, PCP, Texts
Participants received 24 calls, PCP Reports, and Texts
BG031
32. 24 Calls, PCP, Texts, MR, Buddy
Participants received 24 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
BG032
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00018
BG00118
BG00218
BG00318
BG00418
BG00518
BG00618
BG00718
BG00819
BG00918
BG01018
BG01118
BG01218
BG01318
BG01418
BG01518
BG01617
BG01718
BG01817
BG01916
BG02016
BG02117
BG02217
BG02318
BG02417
BG02516
BG02618
BG02717
BG02818
BG02917
BG03017
BG03117
BG032562
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
BG00040.0± 8.6
BG00143.2± 14.2
BG00241.7± 10.9
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00012
BG00118
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG00010
BG00115
BG002
Weight (kg)
Mean
Standard Deviation
Kilograms
Title
Denominators
Categories
Title
Measurements
BG00088.9± 10.6
BG00191.2± 14.0
BG002
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
Weight Change (kg) From Baseline to Month 6, Main Effect of Time
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
ITT population: all randomized participants with at least one weight value. The decision to analyze all randomized participants together for aim 1, rather than separately by arm, was pre-specified in the the Protocol/Statistical Analysis Plan for the purposes of assessing the main effect of time.
Posted
Mean
95% Confidence Interval
Kg
From Baseline to Month 6
ID
Title
Description
OG000
All Reporting Groups
All participants regardless of individual randomly assigned combination of On- or Off switched levels of all intervention factors, weight measured at baseline and at Month 6.
Units
Counts
Participants
OG000562
Title
Denominators
Categories
Title
Measurements
OG000-4.8(-5.3 to -4.4)
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
Mixed Models Analysis
<.001
Superiority
Primary
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).
ITT population: all randomized participants with at least one weight value.
Participant's primary care physician was (On) or was not (Off) sent a progress report after the 3 and 6 month assessments.
OG002
Text Messages
Participants either received (On) or did not receive (Off) push notifications through the app at their preferred time or when they opened the app.
OG003
Secondary
Intervention for <$500
Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.
ITT population: weight loss data from all randomized participants with at least one weight value; combined with cost data for study implementation (staff time, supplies, etc.)
Posted
Number
dollars
6 months
ID
Title
Description
OG000
All Reporting Groups
All participants regardless of individual randomly assigned combination of On- or Off switched levels of all intervention factors.
Units
Counts
Participants
OG000
Other Pre-specified
Treatment Adherence
Treatment adherence is a hypothesized mediator that will be operationalized as the number of treatment sessions completed divided by the number of treatment sessions offered (12 or 24)
Not Posted
6 months
Participants
Other Pre-specified
Self-monitoring Adherence
Self-monitoring is a hypothesized mediator that will be operationalized as the number of days recording weight, dietary intake, and physical activity
Not Posted
6 months
Participants
Other Pre-specified
Self-efficacy
Self-efficacy is an exploratory mediator that will be assessed to examine treatment effects on confidence about performing two categories of behaviors associated with weight loss: diet and physical activity
Not Posted
6 months
Participants
Other Pre-specified
Self-Regulation
Self-regulation is an exploratory mediator that will be assessed using the Three Factor Eating Questionnaire and Treatment Self-Regulation Questionnaire
Not Posted
6 months
Participants
Other Pre-specified
Supportive Accountability
Supportive accountability is an exploratory mediator that will be measured by assessing two constructs that define supportive accountability: therapeutic alliance and perceived autonomy support
Not Posted
6 months
Participants
Other Pre-specified
Facilitation
Facilitation is an exploratory mediator that will be measured by rating how much the tools provided by the study have changed their environment and by the Weight Management Support Inventory
Not Posted
6 months
Participants
Time Frame
Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
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
1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician
Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
0
18
0
18
6
18
EG001
Condition 2
1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
0
19
0
19
8
18
EG009
Condition 10
1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
Text Messages: Participants will receive regular text messages
0
17
0
17
1
17
EG023
Condition 24
1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
Text Messages: Participants will receive regular text messages
0
17
0
17
3
17
EG031
Condition 32
1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
Text Messages: Participants will receive regular text messages
Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
0
17
0
17
1
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Brain bleed
Injury, poisoning and procedural complications
Non-systematic Assessment
Participant slipped and fell on tile floor, hit his head and suffered severe concussion and brain bleeding. Was cleared for full activity after a month of recovery.
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected18 at risk
severe head injury
Injury, poisoning and procedural complications
Non-systematic Assessment
sustained a severe head injury in a car accident, unable to complete study activities
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
thyroid imbalance
Endocrine disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected18 at risk
EG0060 events0 affected18 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected18 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected18 at risk
EG0111 events1 affected18 at risk
EG0120 events0 affected18 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected18 at risk
EG0151 events1 affected18 at risk
EG0160 events0 affected17 at risk
EG0170 events0 affected18 at risk
EG0180 events0 affected17 at risk
EG0190 events0 affected16 at risk
EG0200 events0 affected16 at risk
EG0210 events0 affected17 at risk
EG0220 events0 affected17 at risk
EG0230 events0 affected18 at risk
EG0240 events0 affected17 at risk
EG0250 events0 affected16 at risk
EG0260 events0 affected18 at risk
EG0270 events0 affected17 at risk
EG0280 events0 affected18 at risk
EG0290 events0 affected17 at risk
EG0301 events1 affected17 at risk
EG0310 events0 affected17 at risk
thyroid cancer
Endocrine disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
anterior scleritis
Eye disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
stomach ache
Gastrointestinal disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0022 events1 affected18 at risk
EG003
stomach ulcer
Gastrointestinal disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
constipation
Gastrointestinal disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
colitis
Gastrointestinal disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
medication switch
General disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
bicycle accident
General disorders
Non-systematic Assessment
bicycle accident, no injury
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
neutropenia
Immune system disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
influenza
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected18 at risk
EG003
food poisoning
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected18 at risk
EG003
sinus infection
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
strep throat
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
common cold
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected18 at risk
EG003
bronchitis
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
pneumonia
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected18 at risk
EG003
stomach flu
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected18 at risk
EG003
staph infection
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
general respiratory infection
Infections and infestations
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
ear infection
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected18 at risk
EG003
urinary tract infection
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
mononucleosis
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
intolerance to meal replacements
Product Issues
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
eating disorder
Psychiatric disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
depression
Psychiatric disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected18 at risk
EG003
bladder cancer
Renal and urinary disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
skin cancer
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected18 at risk
EG003
epilepsy
Nervous system disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
pinched nerve
Nervous system disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
seizure disorder
Nervous system disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
spinal stenosis
Nervous system disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
asthma
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
polycystic ovary syndrome
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
abnormal mammogram
Reproductive system and breast disorders
Non-systematic Assessment
doctor monitoring, no official diagnosis
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
uterine prolapse
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
breast cancer
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
osteoarthritis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
tendonitis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
plantar fasciitis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
degenerative disc disease
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
arthritis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
capsulitis
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
dental procedure
Surgical and medical procedures
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
skin surgery
Surgical and medical procedures
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected18 at risk
EG003
foot surgery
Surgical and medical procedures
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0022 events1 affected18 at risk
EG003
hyperhidrosis surgery
Surgical and medical procedures
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
stomach surgery
Surgical and medical procedures
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
elbow surgery
Surgical and medical procedures
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
kidney stone surgery
Surgical and medical procedures
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
lasik eye surgery
Surgical and medical procedures
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
muscle soreness
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
blisters
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
joint soreness
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected18 at risk
EG003
muscle strain
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0002 events2 affected18 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected18 at risk
EG003
ankle sprain
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected18 at risk
EG003
fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
contusion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
laceration
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
migraine
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
muscle cramps
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
knee sprain
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
mild concussion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Bonnie Spring, PhD, ABPP
Northwestern University Feinberg School of Medicine
Participants either received (On) or did not receive (Off) a one week supply of meal replacement bars and shakes. Those who did receive a 1-week supply of meal replacements were provided with recommendations on each coaching call to continue using these products throughout the intervention.
OG004
Buddy Training
Participant buddies either received (On) or did not receive (Off) additional training.
Units
Counts
Participants
OG000562
OG001562
OG002562
OG003562
OG004562
Title
Denominators
Categories
Title
Measurements
OG000.1244(-.3026 to .5513)
OG001-.0226(-.4495 to .4044)
OG002.0840(-.3429 to .5109)
OG003.1081(-.3188 to .5350)
OG004-.4353(-.8622 to -.0084)
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
Mixed Models Analysis
0.567
Estimated Change
0.1244
2-Sided
95
-.3026
.5513
Superiority
OG001
Mixed Models Analysis
0.917
Estimated Change
-0.0226
2-Sided
95
-.4495
.4044
Superiority
OG002
Mixed Models Analysis
0.699
Estimated Change
0.084
2-Sided
95
-.3429
.5109
Superiority
OG003
Mixed Models Analysis
0.619
Estimated Change
0.1081
2-Sided
95
-.3188
.5350
Superiority
OG004
Mixed Models Analysis
0.046
Estimated Change
-0.4353
2-Sided
95
-.8622
-.0084
Superiority
562
Title
Denominators
Categories
Title
Measurements
OG000427
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
Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.