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Recruiting NCT06118528

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

No phase Interventional Wearable Electronic Device

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blur Obfuscation, Cartoon Obfuscation, Edge Obfuscation, No Obfuscation (raw).
Who it may be relevant to
Registry conditions: Wearable Electronic Device. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Blur Obfuscation
    Blurring is applied to the RGB images.
  • Behavioral Cartoon Obfuscation
    Cartoonization is applied to the RGB images.
  • Behavioral Edge Obfuscation
    A black background and simple outlines of objects/people are applied to the RGB images.
  • Behavioral No Obfuscation (raw)
    No editing is performed on the RGB images.

Primary outcome measures

  • Daily wear time [Time frame: 7 days]
Secondary outcome measures (1)
  • Self-report acceptability [Time frame: 7 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Northwestern University — Chicago

Identifiers

NCT: NCT06118528 · STU00215714 · 1R01DK129843-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗