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Completed

NCT Number: NCT06547320

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boston University, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Energy intake per eating occasion

    Time frame: 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

  2. Rate of eating per eating occasion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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