Optimizing a smartphone intervention to reduce dietary lapses in obesity treatment
Optimizing Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: a Micro-randomized Trial
This study is testing a smartphone program that helps people stick to their diet while treating obesity by giving them support when they are at risk of slipping up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 159 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Miriam Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT04784585 on ClinicalTrials.gov |
What this trial studies
This project aims to address dietary lapses, which are common in obesity treatment, by conducting a micro-randomized trial (MRT) that evaluates the effectiveness of a smartphone-based just-in-time adaptive intervention (JITAI). Participants will receive a combination of online behavioral obesity treatment and JITAI over six months, with interventions tailored based on real-time assessments of lapse risk. The study will compare the effects of various interventions on dietary adherence and gather data to refine future interventions. The ultimate goal is to create a scalable JITAI that can significantly improve dietary adherence in obesity treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a BMI between 25 and 50 who have cardiovascular disease risk factors.
Not a fit: Patients currently participating in another weight loss program or those with certain medical conditions that affect safety may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved dietary adherence and better outcomes for individuals undergoing obesity treatment.
How similar studies have performed: Other studies have shown promise with similar just-in-time adaptive interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Providence, Rhode Island
- Weight Control and Diabetes Research Center — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Stephanie P Goldstein, PhD
- Email: stephanie.goldstein@lifespan.org
- Phone: 401-793-9727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.