NCT06118528

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Sep 2024Oct 2026

First Submitted

Initial submission to the registry

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

September 4, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

November 1, 2023

Last Update Submit

May 5, 2026

Conditions

Keywords

WearableElectronicDeviceBehaviorEatPrivacyCameraObesityObfuscationFilterCartoonBlurRawEdgeBurdenWearerBystanderMonitorBMICaloriesToolAlgorithmRGBThermalDataHealthChest

Outcome Measures

Primary Outcomes (1)

  • Daily wear time

    7 days

Secondary Outcomes (1)

  • Self-report acceptability

    7 days

Study Arms (4)

Blur Obfuscation

EXPERIMENTAL
Behavioral: Blur Obfuscation

Edge Obfuscation

EXPERIMENTAL
Behavioral: Edge Obfuscation

Cartoon Obfuscation

EXPERIMENTAL
Behavioral: Cartoon Obfuscation

No Obfuscation (Raw)

EXPERIMENTAL
Behavioral: No Obfuscation (raw)

Interventions

Blurring is applied to the RGB images.

Blur Obfuscation

Cartoonization is applied to the RGB images.

Cartoon Obfuscation

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

Edge Obfuscation

No editing is performed on the RGB images.

No Obfuscation (Raw)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

BehaviorObesity

Interventions

Airway Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 7, 2023

Study Start

September 4, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations