Using a sensor device to change eating behavior in overweight individuals
Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior
This study is testing whether a special sensor device worn on glasses can help people who are overweight change their eating habits for the better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Miriam Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06547320 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a sensor device called the Automatic Ingestion Monitor (AIM), which is worn on eyeglasses, in modifying eating behaviors among individuals with overweight and obesity. Participants will first undergo a week of observation without intervention, followed by two weeks of behavioral interventions that focus on reducing food intake and slowing down eating. The interventions will be guided by messages sent to participants' smartphones based on data collected from the AIM. The researchers hypothesize that this approach will lead to significant changes in eating behavior.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a body mass index (BMI) between 27 and 45 who have been weight stable for the past six months.
Not a fit: Patients with diagnosed diabetes, eating disorders, or other medical conditions affecting weight and eating behavior may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help individuals manage their weight more effectively by promoting healthier eating habits.
How similar studies have performed: Other studies have explored sensor-based interventions for behavior modification, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index (BMI) between 27 and 45 kg/m-squared * Weight stable within 5% in the past 6 months * Self-reports basic familiarity with use of a smartphone Exclusion Criteria: * Diagnosed diabetes (type 1 and 2) * Any poorly controlled medical condition that could affect weight and/or eating behavior (e.g., hypothyroidism) * Medical conditions or use of medications or diets/supplements known to affect energy regulation or appetite * Difficulty chewing or swallowing * Diagnosed eating disorder * Night or shift work * Current participation in a weight loss program * History of bariatric surgery * Current pregnancy or lactation within the past 1 year, or planning a pregnancy during the study participation period * Consuming a medically-prescribed or unusual diet (e.g., macrobiotic) * Food allergies or sensitivities, or other conditions which result in avoidance of a wide range of foods (e.g. celiac disease, tree nut allergy) * Reported recreational drug use * Report of conditions that would significantly interfere with an ability to follow the protocol including terminal illness, substance abuse, or other significant uncontrolled psychiatric problem
Where this trial is running
Boston, Massachusetts and 1 other locations
- Boston University — Boston, Massachusetts, United States (Recruiting)
- The Miriam Hospital Weight Control and Diabetes Resarch Center — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Olly Richards, BSc
- Email: Olly.Richards@Lifespan.org
- Phone: (401) 606-4809
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.