NCT07228130

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Mar 2029

First Submitted

Initial submission to the registry

November 11, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

November 11, 2025

Last Update Submit

February 3, 2026

Conditions

Obesity & Overweight

Keywords

OnlineObesityWeight LossDietPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Adherence to Self-Monitoring

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

    24 weeks

  • Weight Change

    Weight measured in kg on the provided home scale

    24 weeks

Secondary Outcomes (3)

  • Perceived Burden of Assigned Self-Monitoring Approach

    24 weeks

  • Motivation to Engage in Self-Monitoring

    24 weeks

  • Satisfaction With Assigned Self-Monitoring Approach

    24 weeks

Study Arms (5)

Online Behavioral Obesity Treatment with Full Dietary Self-monitoring

EXPERIMENTAL

The Online Behavioral Obesity Treatment intervention combined with the Full Dietary Self-monitoring intervention.

Behavioral: Online Behavioral Obesity TreatmentBehavioral: Full Dietary Self-monitoring

Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring

EXPERIMENTAL

The Online Behavioral Obesity Treatment intervention combined with the Reduced-frequency Dietary Self-monitoring intervention.

Behavioral: Online Behavioral Obesity TreatmentBehavioral: Reduced-frequency Dietary Self-monitoring

Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only

EXPERIMENTAL

The Online Behavioral Obesity Treatment intervention combined with the Self-Monitoring of Dietary Lapses Only intervention.

Behavioral: Online Behavioral Obesity TreatmentBehavioral: Self-Monitoring of Dietary Lapses Only

Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake

EXPERIMENTAL

The Online Behavioral Obesity Treatment intervention combined with the Smartwatch-based Self-monitoring of Energy Intake intervention.

Behavioral: Online Behavioral Obesity TreatmentBehavioral: Smartwatch-based Self-monitoring of Energy Intake

Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only

EXPERIMENTAL

The Online Behavioral Obesity Treatment intervention combined with the Self-monitoring of Body Weight Only intervention.

Behavioral: Online Behavioral Obesity TreatmentBehavioral: Self-monitoring of Body Weight Only

Interventions

Online Behavioral Obesity TreatmentBEHAVIORAL

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.

Online Behavioral Obesity Treatment with Full Dietary Self-monitoringOnline Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoringOnline Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses OnlyOnline Behavioral Obesity Treatment with Self-monitoring of Body Weight OnlyOnline Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake
Full Dietary Self-monitoringBEHAVIORAL

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

Online Behavioral Obesity Treatment with Full Dietary Self-monitoring
Reduced-frequency Dietary Self-monitoringBEHAVIORAL

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

Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring
Self-Monitoring of Dietary Lapses OnlyBEHAVIORAL

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

Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only
Smartwatch-based Self-monitoring of Energy IntakeBEHAVIORAL

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

Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake
Self-monitoring of Body Weight OnlyBEHAVIORAL

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

Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

ObesityOverweightWeight LossMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Graham Thomas, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

  • Stephanie Goldstein, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Eisel Research Project Coordinator

CONTACT

401-793-8283tech2trackstudy@brownhealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The interventional model is a micro-randomized trial, which involves sequential (within-subject) randomization to different self-monitoring approaches throughout behavioral obesity treatment. Each participant will receive a 24-week online behavioral obesity treatment program and will be randomized to one of five SM strategies every two weeks, resulting in a total of 12 randomizations per participant.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2025

First Posted

November 14, 2025

Study Start

January 7, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified baseline data collected via online questionnaire, co-primary outcomes (i.e., participant adherence to SM conditions and weekly weights), data collected via the obesity treatment platform (e.g., website engagement), and data on treatment factors collected at 2-week intervals via questionnaire (e.g., perceived burden, satisfaction) will be shared with participants' consent. Identifiable and quasi-identifiable information will not be shared . Analyzed datasets along with analysis code and codebooks will be preserved and shared. Data will be made accessible via online repository at the time of associated publication(s) or the end of the performance period, whichever comes first, and they will remain publicly accessible as long as it is anticipated that they are useful for the larger research community, institutions, and/or broader public (to be determined by NIDDK-CR or VIVLI protocol).

Locations

US(1)