Just-in-Time Adaptive Intervention for Dietary Lapse in Obesity Treatment
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.
Enhanced Education
+ Online Behavioral Obesity Treatment
+ Self-Efficacy
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.204 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.6 intervention groups are designated in this study
16.667% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
Active ComparatorGroup 6
ShamStudy 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
Weight Control and Diabetes Research Center
Providence, United StatesOpen Weight Control and Diabetes Research Center in Google Maps