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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Eat Less Intervention; Behavioral: Eat Slower Intervention

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • The Miriam Hospital Weight Control and Diabetes Resarch Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Just-in-time Adaptive Intervention; 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; 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.; Behavioral: Eat Slower Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: R01DK122473 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will make data and documentation available under 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No