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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
The Miriam Hospital
Study ID
NCT07228130
Status
Recruiting
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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 7, 2026
Status verified
Feb 2026
Primary completion
Mar 1, 2029
Completion
Mar 1, 2029

Study Design

Enrollment
275 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Online Behavioral Obesity Treatment with Full Dietary Self-monitoring
    The Online Behavioral Obesity Treatment intervention combined with the Full Dietary Self-monitoring intervention.
  • Experimental: Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring
    The Online Behavioral Obesity Treatment intervention combined with the Reduced-frequency Dietary Self-monitoring intervention.
  • Experimental: Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only
    The Online Behavioral Obesity Treatment intervention combined with the Self-Monitoring of Dietary Lapses Only intervention.
  • Experimental: Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake
    The Online Behavioral Obesity Treatment intervention combined with the Smartwatch-based Self-monitoring of Energy Intake intervention.
  • Experimental: Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only
    The Online Behavioral Obesity Treatment intervention combined with the Self-monitoring of Body Weight Only intervention.

Primary Outcome Measure

Adherence to Self-Monitoring [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Weight Control and Diabetes Research Center of The Miriam Hospital & Brown UniversityProvidenceRhode Island02903
Assistant (Research)
[email protected]
4017938154

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By research site
The Weight Control and Diabetes Research Center of The Miriam Hospital & Brown University· Providence, RI

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