Status:
COMPLETED
Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This project targets dietary lapses (instances of nonadherence to dietary goals), a major cause of poor outcomes during behavioral obesity treatment, which is a recommended first-line intervention for...
Detailed Description
The purpose of the 6-month micro-randomized Trial (MRT) is to optimize a just-in-time adaptive intervention (JITAI) for dietary lapses by evaluating the effects of 4 theory-driven interventions on the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04784585
Start Date
October 26 2021
End Date
October 30 2024
Last Update
June 17 2025
Active Locations (1)
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1
Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903