Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity

Wake Forest University (WFU)

Status: Enrolling

Conditions: Obesity & Overweight; Obesity (Disorder)

Treatments: Behavioral: Feedback on Dietary Quality; Behavioral: Feedback on Physical Activity Goal Attainment; Behavioral: Goal Setting Prompt; Behavioral: Feedback on Calorie Goal Attainment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07227051

R01DK140099 (U.S. NIH Grant/Contract)

IRB00135066

Details and patient eligibility

About

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.

Full description

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:

• which of the four additional feedback components improve adherence to self-monitoring, intervention goals, and weight loss the week after they are received?
• are there any differences in message impact depending on the person receiving the message (for example, do some messages work better for younger versus older participants) or their context (for example, are certain messages more or less helpful depending on how well the person is doing in the program)?

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age greater than or equal to 18 years
• BMI greater than or equal to 25.0 kg/m2
• Weight less than or equal to 175 kg (due to scale limit)
• Own a smartphone compatible with Fitbit (e.g., an Apple iPhone running iOS 16.4 or higher or Android smartphone running Android 11 or higher) with a cellular and data plan

Exclusion criteria

• Weight greater than 175 kg (due to a weight limit of the study-provided scale)
• Smartphone device owned deemed incompatible with the Fitbit App
• History of bariatric surgery or plans to obtain bariatric surgery during the study period
• Current use of weight loss medications, or use of weight loss medications in the 6 months prior to initial pre-screening
• Currently participating in a weight-loss program
• Weight loss of greater than or equal to 10 lbs in the 6 months prior to initial pre-screening
• Physical limitations that prevent walking at a brisk pace for at least 10 minutes without stopping
• Use of a pacemaker or other implanted medical device
• Currently pregnant
• Currently breastfeeding
• Less than 1-year post-partum
• Plans to become pregnant within the study period
• Lack of written confirmation that the potential participant has discussed study participation with their physician if they have been diagnosed with diabetes, hypertension, or has have a history of coronary heart disease
• One or more study participants living in the household (enrollment limited to one participant per household)
• Medical conditions that contraindicate weight loss or prevent completion of the study (e.g., current diagnosis of cancer or terminal illness, dementia, etc.)
• Recent (in the past 6 months) changes in medications that affect weight
• Self-reported eating disorder within past 5 years
• Unable to complete the 17-week study (due to plans to relocate during the study period, etc.)
• Unable or unwilling to provide informed consent
• Unable to read English at the 5th grade level
• Unwilling to accept random assignment
• Unable or unwilling to download the study smartphone application, wear the physical activity monitor, or use the study e-scale
• Failure to complete baseline assessment measures
• Failure to complete at least 4 out of 6 days of self-monitoring dietary and weight self-monitoring during the behavioral run-in period
• Any other condition(s) which, in the opinion of the Principal Investigator, would adversely affect participation in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Self Monitoring Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Goal Setting Prompt

Behavioral: Feedback on Calorie Goal Attainment

Behavioral: Feedback on Physical Activity Goal Attainment

Behavioral: Feedback on Dietary Quality