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

NCT ID: NCT06118528

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-04
• Study Completion Date: 2025-10-31

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.

Conditions

Wearable Electronic Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Blur Obfuscation

Group Type: EXPERIMENTAL

Blur Obfuscation

Intervention Type: DEVICE

Blurring is applied to the RGB images.

Edge Obfuscation

Group Type: EXPERIMENTAL

Edge Obfuscation

Intervention Type: DEVICE

A black background and simple outlines of objects/people are applied to the RGB images.

Cartoon Obfuscation

Group Type: EXPERIMENTAL

Cartoon Obfuscation

Intervention Type: DEVICE

Cartoonization is applied to the RGB images.

No Obfuscation (Raw)

Group Type: EXPERIMENTAL

No Obfuscation (raw)

Intervention Type: DEVICE

No editing is performed on the RGB images.

Interventions

Blur Obfuscation

Blurring is applied to the RGB images.

Intervention Type: DEVICE

Cartoon Obfuscation

Cartoonization is applied to the RGB images.

Intervention Type: DEVICE

Edge Obfuscation

A black background and simple outlines of objects/people are applied to the RGB images.

Intervention Type: DEVICE

No Obfuscation (raw)

No editing is performed on the RGB images.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nabil Alshurafa

Role: CONTACT

nabil@northwestern.edu

3125034517

Bonnie Nolan

Role: CONTACT

bonnie.nolan@northwestern.edu

3125031216

Facility Contacts

Nabil Alshurafa, PhD

Role: primary

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DK129843-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00215714

Identifier Type: -

Identifier Source: org_study_id