About this trial
This clinical trial is focused on testing dietary self-monitoring strategies used in behavioral obesity treatment. The goal is to determine which self-monitoring strategies are most useful for whom, at which points in treatment, and under what circumstances.
Researchers will provide a 24-week online behavioral obesity treatment program, and will randomize participants to use one of 5 dietary self-monitoring strategies every two weeks. The five strategies include: recording all food and drink consumed and corresponding energy intake (i.e., "calories") on 7 days per week; recording all food and drink consumed and corresponding energy intake (i.e., "calories") on 3 days per week; self-monitoring of dietary lapses (i.e. any eating/drinking likely to cause weight gain or put weight loss at risk); smartwatch-based monitoring of energy intake (i.e., "calories"); and self-monitoring of body weight only via smart scale.
Participants will:
* Follow a 24-week online program for weight loss and health improvement * Use the assigned self-monitoring strategy every two weeks * Meet with the researchers periodically via online video call and provide research data by answering questions via periodic online surveys.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English language fluent and literate at the 6th grade level
Body mass index (BMI) above 25 kg/m-squared
Able to walk 2 city blocks without stopping
Not currently participating in another weight loss program
Disqualifiers
None
Trial design
Crossover
Treatments tested in this trial
Online Behavioral Obesity Treatment
BehavioralThe online behavioral obesity treatment consists of: (a) 12 weekly multimedia lessons followed by 3 monthly lessons focused on behavioral skills for weight loss and weight loss maintenance; (b) online tools for goal setting, self-monitoring of diet, physical activity, and body weight; and (c) weekly feedback messages summarizing progress toward goals and providing support and problem-solving. Participants are given recommendations to help them set goals based on their self-monitoring condition (i.e., calorie goal, lapse goal, weight loss goal) and are guided to follow a healthy eating plan to achieve weight loss and health improvement. The physical activity goal is based on baseline activity level, with gradual progression from 50 minutes per week to 250 minutes per week of moderate-intensity activity (e.g., brisk walking). The program emphasizes evidence-based behavioral strategies including stimulus control, problem-solving, goal setting, and relapse prevention.
Full Dietary Self-monitoring
BehavioralRecording all food and drink consumed, with calorie estimates, every day.
Reduced-frequency Dietary Self-monitoring
BehavioralRecording all food and drink consumed, with calorie estimates, on 3 days per week.
Self-Monitoring of Dietary Lapses Only
BehavioralRecording only episodes of eating or drinking that likely cause weight gain or put weight loss at risk.
Smartwatch-based Self-monitoring of Energy Intake
BehavioralUsing a smartwatch that detects eating gestures and estimates energy intake (i.e., "calories") via built-in sensors.
Self-monitoring of Body Weight Only
BehavioralWeighing daily using a smart scale that automatically syncs data to the online treatment platform.
Treatment groups
Trial outcomes
Primary outcomes
Adherence to Self-Monitoring
Number of days on which the assigned self-monitoring strategy was used
Weight Change
Weight measured in kg on the provided home scale
Secondary outcomes
Perceived Burden of Assigned Self-Monitoring Approach
Self-reported perceived burden of the self-monitoring approach used during the prior 2 weeks, assessed with items adapted from the User Burden Scale (e.g., "Using this self-monitoring method required too much mental effort"). Higher scores indicate greater perceived burden.
Motivation to Engage in Self-Monitoring
Self-reported motivation to adhere to the assigned SM approach, measured using adapted items from the Motivation for Weight Loss Scale (e.g., "I intend to self-monitor using the assigned strategy on most days over the next two weeks").
Satisfaction With Assigned Self-Monitoring Approach
Self-reported satisfaction with the assigned SM strategy, assessed using items adapted from the Diabetes Treatment Satisfaction Questionnaire (e.g., "How satisfied were you with this self-monitoring strategy?").
Sponsors and contacts
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The Miriam Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator