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| Name | Class |
|---|---|
| University of Florida | OTHER |
| Wake Forest University Health Sciences | OTHER |
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The purpose of this research study is to learn how to identify the most effective ways to provide weekly feedback on participants' progress toward intervention goals during a weight loss program.
This micro-randomized factorial trial is designed to provide information about how to optimize self-monitoring feedback within a behavioral weight management intervention. All participants will attend a "Weight Loss 101" session that covers foundational weight loss education and behavioral skills training. During this session, they will also learn how to use study-provided tools to track their dietary intake, physical activity, and weight.
Each weekly feedback message will be composed by a trained interventionist. Participants will be randomized each week to one of the two conditions to examine how the tone and composition of feedback messages impact participant behaviors and weight loss.
The main questions that this study aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self Monitoring Feedback | Experimental | Participants in this study will complete a 60-minute "Weight Loss 101" session and use study-provided tools to record their daily food intake, physical activity, and weight. After a one-week run-in period, they will begin receiving weekly feedback messages. The content and emphasis of these messages will differ between 2 conditions: positive reinforcement vs. positive reinforcement + areas for change. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Reinforcement | Behavioral | Feedback composed by a study interventionist that focuses exclusively on positively reinforcing the participant's progress toward achieving their goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Mixed-effects models will be used to investigate the impact of each feedback condition on our primary outcome of weight change. Fitted model estimates will be used to calculate the slope of weight change from day 1 (the day a feedback message is delivered) through day 7 of each week. Positive slopes indicate weight gain, while negative slopes indicate weight loss. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of self-monitoring weight | Frequency of self-monitoring weight will be defined as the number of days (0-7) in the week following a feedback message (from day 1, the day that a feedback message is received, to day 7) in which the participant records a valid (non-outlier) e-scale weight. | 7 days |
| Frequency of self-monitoring dietary intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maddie Glover, B.S. | Contact | 4342432387 | ktg7zr@virginia.edu | |
| Teace Markwalter, M.P.H., CHES | Contact | 540-239-6283 | bdwcp@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Becca Krukowski, Ph.D. | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22901 | United States |
Individual-level participant data will be de-identified and made available at the time of publication of peer-reviewed manuscript(s) based on the data. Study data will be shared via the Zenodo data repository at https://zenodo.org/. Analytic code will be made publicly available via Supplementary files for any publications and/or via Zenodo through a Zenodo-GitHub link. Study protocol, informed consent form, statistical analysis plan will also be available to be shared via clinicaltrials.gov.
De-identified, individual-level participant data will be made available at the time of publication of peer-reviewed manuscript(s) based on the data.
Data will be made available via the Zenodo data repository (https://zenodo.org).
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Micro-randomized Factorial. One of two conditions.
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| Positive Reinforcement + Areas for Change | Behavioral | Feedback provided by a study interventionist that combines positive reinforcement of the participant's progress with constructive guidance on areas for improvement to support successful goal attainment. |
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A valid "day" of dietary self-monitoring will be defined as ≥ 800 kcal recorded, consistent with prior research. Frequency is calculated as the number of valid days (0-7) recorded the week after a feedback message is delivered (from day 1, the day that a feedback message is received, to day 7). |
| 7 days |
| Total caloric intake | Total caloric intake will be calculated by summing calories consumed during the week following a feedback message is received (from day 1, the day that a feedback message is received, to day 7) | 7 days |
| Calorie goal attainment | Calorie goal attainment for each day during the week after a feedback message is received (from day 1, the day a feedback message is received, to day 7). Calorie goal attainment will be calculated as [TOTAL KCAL INTAKE FOR THE DAY] - [CALORIE GOAL]. Daily difference scores for the 7 days will be averaged across the week to determine overall adherence to the caloric intake goal. | 7 days |
| Frequency of self-monitoring physical activity | Frequency of self-monitoring physical activity will be defined as the number of "valid" days (0-7) of Fitbit use the week after a feedback message is received (from day 1, the day that a feedback message is received, to day 7). | 7 days |
| Physical activity minutes | Total minutes of physical activity will be calculated by summing each days' total "active zone minutes" during the week after a feedback message is delivered (from day 1, the day that a feedback message is received, to day 7) | 7 days |
| Physical activity goal attainment | Physical activity goal attainment for each day of the week after a feedback message is received (from day 1, the day that a feedback message is received, to day 7) will be calculated as [TOTAL PHYSICAL ACTIVITY MINUTES] - [PHYSICAL ACTIVITY GOAL]. Daily difference scores will be averaged over the week to assess overall adherence to the physical activity goal during that study week. | 7 days |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |