University of Florida
Gainesville, Florida, 32610, United States
NCT Number: NCT06508580
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Gainesville, Florida, 32610, United States
Self-monitoring (e.g., of weight, dietary intake, and physical activity) is a core component in evidence-based comprehensive lifestyle interventions for obesity, and greater adherence to self-monitoring has been associated both with better short-term weight loss and long-term weight loss maintenance. Importantly, research has demonstrated that the provision of interventionist feedback on self-monitoring increases adherence to self-monitoring and improves weight loss outcomes. Little empirical evidence exists, however, to provide guidance on how this feedback should be provided. One study conducted in this area demonstrated that intentions to self-monitor differ by feedback complexity, such that too little (and, conversely, too much) feedback reduces future intentions to self-monitor and engage in related health behavior change; however, less is known regarding how the type and complexity of feedback messages affect actual self-monitoring behavior and subsequent weight loss outcomes. Importantly, provision of this feedback also represents a substantial investment of clinician time; research demonstrated that feedback messages incorporating self-monitoring data related to weight, dietary intake, and physical activity can take ~26 minutes per person to compose. Thus, the investigators propose a line of research that aims to optimize the provision of self-monitoring feedback (i.e., identifying the optimal number and type of feedback messages) for supporting adherence to weight-management behaviors. For the current study, the investigators propose to assess the feasibility and acceptability of a micro-randomized, factorial trial design that will ultimately be used (in a future, fully-powered trial) evaluate the proximal impact of different types and amount of feedback on change in weight and weight-related behaviors (e.g., adherence to self-monitoring, caloric goal attainment, physical activity goal attainment). Using a 2x2x2x2 factorial model, participants will be randomized each week for 16 weeks to one of 16 possible feedback conditions, allowing us to efficiently test four feedback components (i.e., feedback on calorie goal attainment, dietary quality, physical activity goal attainment, or on goal setting) in one study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
On weeks that participants are randomized to receive this component, they will be provided with feedback on the number of days that they met their calorie goal.
On weeks that participants are randomized to receive this component, they will receive three comments regarding specific dietary choices that may impact weight loss success, including reinforcing comments for behaviors consistent with weight loss and potential areas for change.
On weeks that participants are randomized to receive this component, they will receive feedback related to attainment of that week's physical activity goal.
On weeks that participants are randomized to receive the goal setting component, they will be asked to complete an open-text prompt encouraging them to set a specific weight-related behavior change goal for the next week.
Time frame: Daily throughout the study period (up to 17 weeks)
Weight will be assessed using the study-provided e-scales
Time frame: Weekly throughout the study period (up to 17 weeks)
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.
Time frame: Weekly throughout the study period (up to 17 weeks)
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.
Time frame: Weekly throughout the study period (up to 17 weeks)
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.
Time frame: Weekly throughout the study period (up to 17 weeks)
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.
Time frame: Weekly throughout the study period (up to 17 weeks)
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.
Time frame: Weekly throughout the study period (up to 17 weeks)
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.
Time frame: Weekly throughout the study period (up to 17 weeks)
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.
Time frame: Weekly throughout the study period (up to 17 weeks)
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.
University of Florida
Other
Optimizing Self-Monitoring Feedback Delivery for the Treatment of Obesity
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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