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

NCT06547320 | Completed Phase 2

• 1 other identifier: R01DK122473
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Total energy intake

  Total amount of energy consumed from foods and beverages

  Daily average computed for the 7-day observation period and each 7-day intervention period

Secondary Outcomes (2)

• Energy intake per eating occasion

  Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period

• Rate of eating per eating occasion

  Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period

Study Arms (1)

Just-in-time Adaptive Intervention

EXPERIMENTAL

A sensor device called an Automatic Ingestion Monitor (AIM) will be worn on eyeglasses to monitor eating. Information from the device will be used to send messages to a smartphone to change eating behavior.

Behavioral: Eat Less Intervention; Behavioral: Eat Slower Intervention

Interventions

Eat Less Intervention BEHAVIORAL

A sensor worn on eyeglasses monitors eating and provides messages to a smartphone when eating occurs to prompt small reductions in the amount of food eaten.

Just-in-time Adaptive Intervention

Eat Slower Intervention BEHAVIORAL

A sensor worn on eyeglasses monitors eating and provides messages to a smartphone when eating occurs to prompt small reductions in the rate of eating.

Just-in-time Adaptive Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (2)

Boston University

Boston, Massachusetts, 02215, United States

Location

The Miriam Hospital Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: January 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Access Criteria: A data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.

Locations

US (2)