Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL178992 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
The goal of this study is to test multiple individual treatment components added to a 6-month standard mobile behavioral weight loss program that are intended to help participants follow dietary recommendations and meet their dietary goals more often. The four components to be studied include switching dietary tracking methods, receiving access to a goal planning tool, receiving additional personalized text messages, and receiving three sessions with a health coach. The study will identify the best combination of these additional treatments for improving total number of weeks in the program that participants meet their dietary goals.
SHIFT uses a highly efficient experimental design as part of the Multiphase Optimization Strategy (MOST) to optimize a 6-month behavioral weight loss intervention for improved dietary adherence among adults with overweight and obesity with initial nonresponse to the intervention. Investigators will test four unique treatment components added to a core mobile behavioral weight loss program.
All participants will receive the Core 6-month behavioral weight loss program, which is a comprehensive intervention that includes evidence-based behavior change strategies to promote self-monitoring and adherence to personalized dietary and activity goals. The program includes an individual kick-off session, native smartphone application, text messages, daily goals, self-monitoring of diet, weight, and physical activity, weekly lessons, tailored weekly feedback, and will start with 5-6 text messages per week. The intervention targets both dietary and physical activity changes, with a greater emphasis placed on improved dietary behaviors as the primary strategy for weight loss. Participants with lower than expected adherence to their dietary goals early in the program (weeks 3-8; "nonresponders") will be randomly assigned in a 2x2x2x2 factorial trial to the On or Off level of each of these 4 additional treatments added onto the core program: 1) switching dietary self-monitoring approach (Simplified Diet), 2) adding an autonomous goals and planning tool (Goal Autonomy + Planning), 3) adding just-in-time text messaging (JIT Messaging) 4) receiving 3 telehealth sessions with a health coach (Coach). Thus, each of these participants will receive 0-4 additional treatment components for the remainder of the 6-month program. Participants with recommended levels of dietary adherence in the first 8 weeks ("responders") remain in the Core program and are not randomized in the factorial trial.
All participants (those in the factorial trial and the responders who remain in the Core only) will complete assessments at baseline, 4 weeks (brief/online only), 8 weeks (brief/online only), 3 months, and 6 months. Primary and secondary research aims are limited to participants who are randomized into the factorial trial (estimated to be approximately 65% of the total sample). The primary aim is to determine the combination of additional intervention components that maximize dietary adherence from time of randomization to 6 months among participants with low early dietary adherence. A secondary outcome is percent of participants reaching 5% weight loss from baseline to 6 months.
Decision analysis for intervention value efficiency (DAIVE) will be the decision-making approach used to select the treatment components included in the final, optimized intervention. DAIVE uses a Bayesian factorial analysis of variance that maximizes the expected value of the outcome by evaluating the predicted value associated with all possible combinations of the components. DAIVE will be used maximize the expected value of both mean total weeks of dietary adherence from randomization to 6 months and proportion reaching 5% weight loss at 6 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 | Experimental | Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions |
|
| Condition 2 | Experimental | Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging |
|
| Condition 3 | Experimental | Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Coach Sessions |
|
| Condition 4 | Experimental | Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning |
|
| Condition 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core | Behavioral | Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Total weeks of dietary goal adherence | Objective self-monitoring of dietary intake (pulled via the Fitbit API for those in the conditions with standard dietary self-monitoring and the Traffic Light Log app API for the those in conditions that switch to simplified dietary self-monitoring) will be used to calculate, among nonresponders randomized into the factorial trial, number of days after randomization in which the dietary goal (calorie goal or red food goal) was met ≥ 3 days/week (the daily dietary goal is defined as a complete day of tracking and ≤ the calorie/red food goal). | Time of randomization to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants reaching >= 5% weight loss | Scale weights at baseline and 6 months will be used to calculate, among nonresponders randomized into the factorial trial, percent weight change ( [(weight at 6 months - baseline weight) / baseline weight] × 100) and classify participants as achieving or not achieving at least 5% weight loss. | Baseline to 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Individuals endorsing joint problems, current treatment for hypertension or hyperlipidemia, or osteoporosis diagnosis not on medication will be required to obtain written physician consent to participate.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen E Hatley, MPH | Contact | 919-966-5852 | 2 | keericks@email.unc.edu |
| Brooke T Nezami, PhD | Contact | 919-966-5852 | 2 | bnezami@unc.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
Deidentified individual data that supports the primary outcome results will be made available through the UNC Dataverse (https://dataverse.unc.edu/).
Not provided
The shared data will have a persistent unique identifier (DOI) from the UNC Dataverse repository. The data will also be discoverable online through a standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset.
Not provided
Not provided
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
This study uses a full factorial experimental design testing the efficacy of four intervention components, each with an on and off level.
Not provided
Not provided
Not provided
Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions |
|
| Condition 6 | Experimental | Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging |
|
| Condition 7 | Experimental | Core + Switch to Simplified Diet Monitoring + Coach Sessions |
|
| Condition 8 | Experimental | Core + Switch to Simplified Diet Monitoring |
|
| Condition 9 | Experimental | Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions |
|
| Condition 10 | Experimental | Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging |
|
| Condition 11 | Experimental | Core with Standard Diet Monitoring + Goal Autonomy/Planning + Coach Sessions |
|
| Condition 12 | Experimental | Core with Standard Diet Monitoring + Goal Autonomy/Planning |
|
| Condition 13 | Experimental | Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions |
|
| Condition 14 | Experimental | Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging |
|
| Condition 15 | Experimental | Core with Standard Diet Monitoring + Coach Sessions |
|
| Condition 16 | Experimental | Core with Standard Diet Monitoring |
|
| Core Only (Responders) | Other | Core program (participants who are not randomized in the factorial intervention) |
|
|
| Switch to Simplified Diet Monitoring | Behavioral | Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system. |
|
| Goal Autonomy/Planning | Behavioral | A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week. |
|
| Just-in-time (JIT) Messaging | Behavioral | Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change. |
|
| Coach Sessions | Behavioral | Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization. |
|
| Total days of dietary goal adherence | Objective self-monitoring of dietary intake (pulled via the Fitbit API for those in the conditions with standard dietary self-monitoring and the Traffic Light Log app API for the those in conditions that switch to simplified dietary self-monitoring) will be used to calculate, among nonresponders randomized into the factorial trial, number of days after randomization in which the dietary goal (calorie goal or red food goal) was met (the daily dietary goal is defined as a complete day of tracking and ≤ the calorie/red food goal). | Time of randomization to 6 months |
| Weight Change (kg) | Estimated mean weight change in kg from baseline to 6 months among nonresponders randomized into the factorial trial. More negative values of weight change indicate greater weight loss. Weights will be objectively measured in light clothes, without shoes, on the digital smart scales in participants' homes. | Baseline, 6 months |
| Dietary intake | Diet will be assessed using the self-administered National Cancer Institute's Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, a free, web-based tool for 24-hour recalls. Participants will complete unscheduled recalls on a weekday and a weekend day at each timepoint. Change in average total kcals/day will be calculated among nonresponders randomized into the factorial trial. Changes are calculated as (average daily kcal at 3/6 months - average daily kcal at baseline). | Baseline, 3 months, 6 months |