Recruiting

Dietary Self-Monitoring

Sponsor:

The Miriam Hospital

Code:

NCT07228130

Conditions

Obesity & Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Online Behavioral Obesity Treatment

Full Dietary Self-monitoring

Reduced-frequency Dietary Self-monitoring

Self-Monitoring of Dietary Lapses Only

Smartwatch-based Self-monitoring of Energy Intake

Study Details

Brief 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

Study ID

NCT07228130

Start date

Jan 7, 2026

Status verified date

Feb, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

275 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Full Dietary Self-monitoring

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

Reduced-frequency Dietary Self-monitoring

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

Self-Monitoring of Dietary Lapses Only

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

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

Self-monitoring of Body Weight Only

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jill Eisel Research Project Coordinator

401-793-8283tech2trackstudy@brownhealth.org

Locations

The Weight Control and Diabetes Research Center of The Miriam Hospital & Brown University

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Assistant (Research)

4017938154jthomas4@lifespan.org

More Information

Sponsor

The Miriam Hospital

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Online
  • Obesity
  • Weight Loss
  • Diet
  • Physical Activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2026-02-04.