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

Summary

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.

Conditions

• Obesity & Overweight

Interventions

BEHAVIORAL

Online Behavioral Obesity Treatment

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.

BEHAVIORAL

Full Dietary Self-monitoring

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

BEHAVIORAL

Reduced-frequency Dietary Self-monitoring

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

BEHAVIORAL

Self-Monitoring of Dietary Lapses Only

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

BEHAVIORAL

Smartwatch-based Self-monitoring of Energy Intake

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

BEHAVIORAL

Self-monitoring of Body Weight Only

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• The Miriam Hospital

  lead OTHER

Principal Investigators

• Graham Thomas, PhD · The Miriam Hospital

• Stephanie Goldstein, PhD · The Miriam Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-07

Primary Completion

2029-03-01

Completion

2029-03-01

Countries

• United States

Study Locations