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

Lifespan

Status and phase: Enrolling; Phase 2

Conditions: Overweight and Obesity

Treatments: Behavioral: Eat Slower Intervention; Behavioral: Eat Less Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06547320

R01DK122473 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Just-in-time Adaptive Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Eat Less Intervention

Behavioral: Eat Slower Intervention