- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290179
Evaluating the Validity and Feasibility of a Smartwatch-based Eating Detection System to Passively and Automatically Detect Eating Events in Child-parent Dyads
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hanim E Diktas, PhD
- Phone Number: (225) 763-2832
- Email: hanim.diktas@pbrc.edu
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Recruiting
- Pennington Biomedical Research Center
-
Contact:
- Hanim E Diktas, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Parents or caregivers (18-70 years) who have children aged 8-12 years
- Child is willing and able to wear smartwatch during school hours (have not restrictions in the school setting)
Exclusion Criteria:
- Any condition or circumstance that could impede study completion
- Child does not follow a regular eating pattern
- Child eats less than 1 meal and 1 snack in a day
- Child is restricted or allergic to the study foods
- Refusal or unable to use the smartwatch to collect data for the 3-day period in free - living conditions
- Parental refusal or unable to respond Ecological Momentary Assessment prompts
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy and Performance of Smartwatch-based Eating Detection System in Controlled Conditions
Time Frame: During the controlled laboratory session (Day 1).
|
Accuracy and performance of smartwatch-based system for detecting eating and drinking events compared to video-coded ground truth during a controlled laboratory conditions. Metrics include: Precision (proportion of correctly detected eating events among all detected events), Recall/Sensitivity (proportion of actual eating events detected), Specificity (proportion of non-eating events correctly identified as non-eating) F1-score (harmonic mean of precision and recall), Overall accuracy (proportion of correct classification). |
During the controlled laboratory session (Day 1).
|
|
Adherence to Smartwatch Protocol
Time Frame: During the free-living phase (Days 2-4).
|
Proportion of families meeting adherence criteria, defined as both parent and child wearing the smartwatch during eating on at least 2 of 3 days and the parent responding to ≥75% of EMA prompts related to smartwatch charging and app functionality.
|
During the free-living phase (Days 2-4).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hanim E Diktas, PhD, Pennington Biomedical Research Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2025-029
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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