Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior

Phase 2

Recruiting

• Conditions: Overweight and Obesity

• Registration Number: NCT06547320
• Lead Sponsor: The Miriam Hospital

Brief Summary

The purpose of this study is to determine whether a sensor device called an Automatic Ingestion Monitor (AIM) that is worn on eyeglasses can be used with a smartphone to change eating behavior. Participants will wear the device for one week of no-intervention observation. They will then test behavioral interventions focused on eating for two weeks. The researchers hypothesize that messages sent to a smartphone that are based on information from the AIM can reduce the amount of food that is eaten and slow eating.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-30
• Study Start: 2024-08-01
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-07-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total energy intake	Daily average computed for the 7-day observation period and each 7-day intervention period	Total amount of energy consumed from foods and beverages

Secondary Outcome Measures

Name	Time	Method
Energy intake per eating occasion	Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period	Amount of energy consumed from foods and beverages during each eating occasion
Rate of eating per eating occasion	Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period	Chews per minute during each eating occasion.

Trial Locations

Locations (2)

Boston University; 🇺🇸 Boston, Massachusetts, United States

The Miriam Hospital Weight Control and Diabetes Resarch Center; 🇺🇸 Providence, Rhode Island, United States