EAT: A Reliable Eating Assessment Technology for Free-living Individuals

Sponsor

Northwestern University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06118528

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study utilizes a small, privacy-conscious wearable device intended to monitor human behaviors. The device is worn around the neck, capturing the wearer's head and upper torso within its field of view, and records color images without audio. Participants visit the lab for consent, device training and recording of several activities using the device. Participants will then take the device home and wear it during their normal schedules for four "active" weeks. During each active week, participants will wear the device, keep a log of all food and drink items consumed throughout the day and participate in unscheduled phone calls with a dietitian. A "washout" week occurs in between each active week in which participants do not need to complete any study tasks. Alongside the device, we have included three privacy filters (blur, edge, and avatar) capable of obscuring faces and objects seen in the device-captured images. All participants will be subject to unfiltered recording during their first week followed by a different filter each following active week in a random order. At the start of each active week, participants view an example of what their recorded images will look like that week (given the privacy filter). At the end of the seven weeks, participants will return the device and provide the lab with feedback on the design of the device and its privacy-preserving features.

Condition or Disease	Intervention/Treatment	Phase
Wearable Electronic Device	Device: Blur Obfuscation Device: Avatar Obfuscation Device: Edge Obfuscation Device: No Obfuscation (raw)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

EAT: A Reliable Eating Assessment Technology for Free-living Individuals

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blur Obfuscation	Device: Blur Obfuscation Blurring is applied to the RGB images.
Experimental: Edge Obfuscation	Device: Edge Obfuscation A black background and simple outlines of objects/people are applied to the RGB images.
Experimental: Avatar Obfuscation	Device: Avatar Obfuscation Cartoonization and avatars are applied to the RGB images.
Experimental: No Obfuscation (Raw)	Device: No Obfuscation (raw) No editing is performed on the RGB images.

Outcome Measures

Primary Outcome Measures

Daily wear time [7 days]

Secondary Outcome Measures

Self-report acceptability [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI greater than or equal to 18.5
Chicago metropolitan area resident
Able to speak, read and write in English
Has a valid phone number
Owns a smartphone
Has access to a computer

Exclusion Criteria:

Pregnant or breastfeeding individuals
Experienced significant weight loss/gain in the last three months (25 lbs or more)
Diagnosed with or has a family history of genetic obesity syndromes (e.g., Prader-Willi, Bardet-Biedl, Cohen Syndrome)
Member of household enrolled in the study