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Clinical Trials/NCT06547320
NCT06547320
Completed
Phase 2

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

The Miriam Hospital2 sites in 1 country43 target enrollmentJanuary 1, 2025

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
The Miriam Hospital
Enrollment
43
Locations
2
Primary Endpoint
Total energy intake
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2025
End Date
May 30, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

Total energy intake

Time Frame: 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 Outcomes

  • 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 Sites (2)

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