Optimizing Self-Monitoring Feedback for the Treatment of Obesity
NCT Number: NCT06508580
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Weight Loss
Interventions: BEHAVIORAL: Component 1: Calorie Goal Attainment|BEHAVIORAL: Component 2: Diet Quality|BEHAVIORAL: Component 3: Physical Activity Goal Attainment|BEHAVIORAL: Component 4: Goal Setting
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-23
Completion Date: 2025-03-31
Locations: University of Florida, Gainesville, Florida, 32610, United States

Summary:
Self-monitoring (of weight, intake, and activity) is a core component in evidence-based lifestyle interventions for obesity. Research has shown that interventionist feedback increases adherence to self-monitoring and improves weight loss outcomes; however, little empirical evidence exists on how this feedback should be provided. This research study aims to optimize the provision of self-monitoring feedback.

Primary Outcome Measures: Weight, Weight will be assessed using the study-provided e-scales, Daily throughout the study period (up to 17 weeks)
Secondary Outcome Measures: Frequency of Self-Monitoring Weight, Frequency of self-monitoring of weight will be defined as the number of days (0-7) each study week that a participant had a valid (e.g., non-outlier) weight recorded via the study-provided e-scale., Weekly throughout the study period (up to 17 weeks)|Frequency of Self-Monitoring Dietary Intake, A valid "day" of self-monitoring dietary intake will be defined as ≥ 800 kcal recorded via the Fitbit app or website, consistent with prior research. For each study week, frequency of self-monitoring dietary intake will be defined as the number of valid days (0-7) recorded., Weekly throughout the study period (up to 17 weeks)|Total Caloric Intake, For each study week, total caloric intake will be calculated by summing calories recorded via the Fitbit app or website each day of that week between 12:00 AM and 11:59 PM local time., Weekly throughout the study period (up to 17 weeks)|Calorie Goal Attainment, Calorie goal attainment each day of the week will be calculated as \[TOTAL KCAL INTAKE FOR THE DAY\] - \[CALORIE GOAL\], using calorie data recorded via the Fitbit app or website. Difference scores for the 7 days will be averaged over the week to assess overall adherence to the caloric intake goal during each study week., Weekly throughout the study period (up to 17 weeks)|Frequency of Self-Monitoring Physical Activity, Consistent with the broader accelerometry literature, a "valid day" of self-monitoring physical activity will be defined as a day with ≥10 hours of Fitbit wear time, assessed as minutes of non-zero heart rate measurements captured by the Fitbit device. For each study week, frequency of self-monitoring physical activity will be defined as the number of "valid" days (0-7) of Fitbit use., Weekly throughout the study period (up to 17 weeks)|Physical Activity Minutes, For each study week, total minutes of physical activity will be calculated by summing the total "active zone minutes" recorded via a Fitbit activity monitor for each day of the week., Weekly throughout the study period (up to 17 weeks)|Physical Activity Goal Attainment, For each study week, physical activity goal attainment will be calculated as \[TOTAL PHYSICAL ACTIVITY MINUTES\] - \[PHYSICAL ACTIVITY GOAL\], with physical activity minutes recorded via a Fitbit activity monitor., Weekly throughout the study period (up to 17 weeks)|Feedback Message Acceptability, Participants will be asked to rate the helpfulness of feedback messages received each week by selecting a "thumbs up" or "thumbs down" button displayed beneath the message., Weekly throughout the study period (up to 17 weeks)