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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK140099 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Virginia | OTHER |
| University of Florida | OTHER |
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The purpose of this research study is to learn how to best provide weekly feedback on individual progress toward intervention goals during a weight loss program.
The goal of this micro-randomized factorial trial is to learn how to best deliver self-monitoring feedback during a behavioral weight management intervention. All study participants will be provided with a "Weight Loss 101" session that provides weight loss education and behavioral skills training. At this meeting, participants will be taught how to use study-provided tools to self-monitor their dietary intake, physical activity, and weight. At the end of each week of the intervention, participants will receive an interventionist-composed feedback message based on their self-monitoring data. Every message will contain feedback about how often the participant self-monitored their dietary intake, physical activity, and weight (that is, the number of days each week that the participant monitored each) along with a message about their weight trajectory. Participants will be randomized each week to receive (or not receive) four additional feedback components each week.
The main questions that this study aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self Monitoring Feedback | Experimental | Participants enrolled in the Feedback Optimization trial will be asked to complete a 60-minute Weight Loss 101 session and to track their dietary intake, physical activity, and weight each day using study-provided tools. After the first week of self-monitoring (used as a run-in), participants will be provided with weekly feedback messages. The focus and content of these messages will vary, based on a 2x2x2x2 factorial design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback on Calorie Goal Attainment | Behavioral | Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their caloric intake goal. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Fitted model values will then be used to estimate the slope of weight change from day 1 (the day a feedback message is received) to day 7 of each week, with positive values representing weight gain and negative values representing 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) for the week after a feedback message is received (from day 1, the day that a feedback message is received, to day 7) that a participant has a valid (non-outlier) e-scale weight. | 7 days |
| Frequency of self-monitoring dietary intake |
| Measure | Description | Time Frame |
|---|---|---|
| Time to compose intervention messages (intervention costs) | Interventionists will log the time needed to compose each message (including a starting time and an ending time for each message) in our administrative dashboard | through study completion, an average of 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tejashri Ganbote, MBA, MBBS | Contact | 414-363-1229 | Tejashri.ganbote@aah.org | |
| Teace Markwalter, M.P.H., CHES | Contact | 866-271-7217 | bdw9cp@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathryn M. Ross, Ph.D., M.P.H. | Aurora Research Institute LLC | Principal Investigator |
| Rebecca A. Krukowski, Ph.D. | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Aurora Research Institute | Recruiting | Milwaukee | Wisconsin | 53204 | United States |
Individual-level participant data will be de-identified and made available: (1) within one year from the final outcome assessment date, (2) at the time of publication of peer-reviewed manuscript(s) based on these data, or (3) at the end of the award, whichever is soonest. 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: (1) within one year from the final outcome assessment date, (2) at the time of publication of peer-reviewed manuscript(s) based on these data, or (3) at the end of the award, whichever is soonest.
Data will be made available via the Zenodo data repository (https://zenodo.org).
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Micro-randomized Factorial. Under a 2x2x2x2 factorial design, participants will be randomized each week for 16 weeks to one of 16 conditions
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| Feedback on Dietary Quality | Behavioral | Feedback composed by a study interventionist that provides comments on specific dietary choices that may impact weight loss success. |
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| Feedback on Physical Activity Goal Attainment | Behavioral | Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal. |
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| Goal Setting Prompt | Behavioral | An open-text goal setting prompt, composed by the study interventionist, that encourages the participant to set a behavioral goal for the following week. |
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A valid "day" of self-monitoring dietary intake will be defined as ≥ 800 kcal, consistent with prior research. Frequency of self-monitoring dietary intake will be defined as the number of valid days (0-7) recorded the week after a feedback message is received (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 the week after 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 that a feedback message is received, to day 7) will be calculated as [TOTAL KCAL INTAKE FOR THE DAY] - [CALORIE GOAL]. Difference scores for the 7 days will be averaged over the week to assess overall adherence to the caloric intake goal during that study week. | 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 received (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]. Difference scores for the 7 days will be averaged over the week to assess overall adherence to the physical activity goal during that study week | 7 days |
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |
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