Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508580
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Optimizing Self-Monitoring Feedback for the Treatment of Obesity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Self-Monitoring Feedback Delivery for the Treatment of Obesity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Self-monitoring eg 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 ie identifying the optimal number and type of feedback messages for supporting adherence to weight-management behaviors For the current study the investigators propose to conduct a micro-randomized factorial trial that will evaluate the proximal impact of different types and amount of feedback on change in weight and weight-related behaviors eg 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 ie feedback on calorie goal attainment dietary quality physical activity goal attainment or on goal setting in one study Mixed-effects models will be used to assess the effects of the four specified feedback components on weight change the week after each component is provided ie over the following study week As a secondary aim the investigators propose to investigate whether the effectiveness of certain types and combinations of feedback is affected by individual or contextual factors A similar multivariate mixed-effects modeling approach will be used to investigate potential moderators of feedback effectiveness ie age gender and race and whether different combinations of feedback are more effective when individuals are doing well in the program compared to when they are not doing well Finally time-dependent effects of feedback components eg whether some feedback components are more effective earlier or later in the intervention will be examined by investigating interactions between time and feedback condition with time modeled both as a linear and polynomial effect Results will inform development of an optimized protocol for feedback provision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None