Suspended

Just-in-Time Adaptive Intervention for Dietary Lapse in Obesity Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to provide a just-in-time adaptive intervention for dietary lapses in obesity treatment, assessing your dietary habits through ecological momentary assessments multiple times a day.

What is being tested

Enhanced Education

+ Online Behavioral Obesity Treatment

+ Self-Efficacy

Behavioral
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: October 2021
See protocol details

Summary

Principal SponsorThe Miriam Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 26, 2021

Actual date on which the first participant was enrolled.

This study focuses on improving dietary habits in individuals undergoing obesity treatment. The research aims to optimize a just-in-time adaptive intervention (JITAI) that helps manage dietary lapses. This JITAI has been previously piloted and will be executed using a recognized mobile platform. The study will recruit a diverse group of 159 participants who will undergo a 6-month program consisting of 3 months of online behavioral obesity treatment combined with JITAI, followed by 3 months of JITAI-only. The primary goal is to evaluate the effectiveness of this intervention in reducing dietary lapses and improving eating behaviors, ultimately aiming to enhance obesity treatment outcomes. During the study, participants will be randomly assigned to different intervention options each time the JITAI identifies an increased risk of dietary lapse. The interventions include education on lapse triggers, enhancing self-efficacy, boosting motivation, and improving self-regulation skills. Participants will complete surveys called ecological momentary assessments (EMAs) multiple times a day to assess dietary lapses. Secondary outcomes include measuring eating characteristics using a wrist-watch device and evaluating contextual moderators like location, time of day, and trigger type. Participants will also be asked to attend three assessments at baseline, 3, and 6 months to collect demographic information, weight history, and provide calorie and physical activity goals.

Official TitleOptimizing Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: A Micro-randomized Trial
NCT04784585
Principal SponsorThe Miriam Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

204 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

Inclusion Criteria: * Age 18-70 * Body mass index (BMI) between 25 and 50 kg/m-squared * Diagnosis of one or more cardiovascular disease risk factors (prediabetes, type 2 diabetes, hypercholesterolemia, or hypertension) * Able to walk 2 city blocks without stopping Exclusion Criteria: * Currently participating in another weight loss program * Currently taking weight loss medication * Lost \> 5% of their body weight in the 6 months prior to enrolling * Has been pregnant within the 6 months prior to enrolling * Plans to become pregnant within 6 months of enrolling * Has chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling * Has any medical condition that would affect the safety of participating in unsupervised physical activity * Has history of bariatric surgery * Has 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

16.667% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Theory-driven intervention focused on providing information about dietary quality and goals

Group II

Experimental
Theory-driven intervention focused on providing skills to increase self-efficacy for following dietary goals

Group III

Experimental
Theory-driven intervention focused on providing skills to increase motivation for following dietary goals

Group IV

Experimental
Theory-driven intervention focused on providing skills to increase self-regulation

Group 5

Active Comparator
A notification to alert participant of lapse risk, no additional intervention provided

Group 6

Sham
No notification or intervention is delivered to the participant during lapse risk

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Weight Control and Diabetes Research Center

Providence, United StatesOpen Weight Control and Diabetes Research Center in Google Maps
SuspendedOne Study Center