Clinical trial

Microrandomized Trial to Optimize Use of Burden-reducing Self-monitoring Approaches in Behavioral Obesity Treatment

Recruiting now · Not applicable · 1 countries · Registry ID NCT07228130

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity & Overweight

Full registry criteria

* 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 * Not currently taking weight loss medication * Has not lost ≥5% of body weight in the 6 months prior to enrolling * Has not been pregnant within the 6 months prior to enrolling * Does not plan to become pregnant within 12 months of enrolling * Denies having a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling * Denies any medical condition that would affect the safety of participating in unsupervised physical activity * Denies any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness * Owns a smartphone compatible with study procedures and is willing to use it for study participation

Treatments and study arms

Online Behavioral Obesity Treatment

Behavioral

The 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

Behavioral

Recording all food and drink consumed, with calorie estimates, every day.

Reduced-frequency Dietary Self-monitoring

Behavioral

Recording all food and drink consumed, with calorie estimates, on 3 days per week.

Self-Monitoring of Dietary Lapses Only

Behavioral

Recording only episodes of eating or drinking that likely cause weight gain or put weight loss at risk.

Smartwatch-based Self-monitoring of Energy Intake

Behavioral

Using a smartwatch that detects eating gestures and estimates energy intake (i.e., "calories") via built-in sensors.

Self-monitoring of Body Weight Only

Behavioral

Weighing daily using a smart scale that automatically syncs data to the online treatment platform.

Primary outcomes

Adherence to Self-Monitoring24 weeks

Number of days on which the assigned self-monitoring strategy was used

Weight Change24 weeks

Weight measured in kg on the provided home scale

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The Weight Control and Diabetes Research Center of The Miriam Hospital & Brown University🇺🇸 Providence, Rhode Island, United States
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