- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07229508
Developmental Trajectories of Reinforcer Pathology and Childhood Obesity (TRACK)
November 13, 2025 updated by: Leonard Epstein, State University of New York at Buffalo
Trajectories of Reinforcement, Activity, and Consumption in Kids
The goal of this observational study is to understand how children's food preferences, physical activity, and decision-making change over time and how these behaviors relate to body weight and overall health.
Study Overview
Status
Recruiting
Conditions
Detailed Description
A cohort sequential design will be used to track 2 cohorts of children aged 8.5-9 years 11 months, and 10.5-11 years 11 months over a 3 year period to understand how the development of food and activity reinforcement and delay discounting could lead to the development of childhood obesity in children aged 9-14.
Study Type
Observational
Enrollment (Estimated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mary J Hite, BA
- Phone Number: 7168292261
- Email: maryjohi@buffalo.edu
Study Contact Backup
- Name: Katelyn Carr, PhD
- Phone Number: 7168296814
- Email: kcarr@buffalo.edu
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14214
- Recruiting
- State University of New York at Buffalo
-
Contact:
- Mary J Hite, BA
- Phone Number: 7168292261
- Email: maryjohi@buffalo.edu
-
Contact:
- Katelyn Carr, PhD
- Phone Number: 7168296814
- Email: kcarr@buffalo.edu
-
Principal Investigator:
- Leonard H Epstein, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Male and female children of varying racial/ethnic backgrounds, SES backgrounds, and varying body compositions
Description
Inclusion Criteria:
- Male and female children
- Black, Indigenous, and People of Color (BIPOC) or Hispanic families
- Children from low SES families (as defined by household education, eligibility for government assistance)
- Children in overweight/obese category (defined by range in each cohort)
Exclusion Criteria:
- Medical causes for obesity
- Stature below the 5th percentile
- Physical activity restrictions
- Psychopathology
- Medication use that affects activity or appetite
- Children that spend less than 65% of their time in participating parent's household
- BMI percentile criteria
- Liking of study foods and activities
- Dietary restrictions and food allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Aged 8.5-9
Children that are enrolled when they are 8.5- 9 years, 11 months of age
|
|
Aged 10.5-11
Children that are enrolled when they are 10.5-11 years, 11 months age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
zBMI
Time Frame: 0, 12, 24 and 36 months
|
Height and weight will be measured to determine zBMI using the CDC extended BMI-for-age growth charts.
First, height (m) and weight (kg) will be used to calculate BMI (kg/m^2), then, using the CDC extended BMI-for-age growth charts, a zBMI score will be determined based on the charts.
|
0, 12, 24 and 36 months
|
|
body fat
Time Frame: 0, 12, 24 and 36 months
|
Body fat (% of body weight) will be measured using the Tanita BF-400 Total Body Analyzer.
|
0, 12, 24 and 36 months
|
|
percent change over the overweight BMI
Time Frame: 0, 12, 24 and 36 months
|
Height and weight will be measured to calculate changes in overweight status of children.
Change in percent overweight from 0, 12, 24, 36 months.
First, height and weight will be used to calculate BMI (kg/m^2), then CDC extended growth charts will be used to determine BMI percentile.
Percent overweight is calculated as ((childBMI percentile - 85th BMI percentile)/(85th BMI percentile)) x 100.
Percent over the age- and sex- specific 85th BMI percentile for children will be used.
|
0, 12, 24 and 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leonard H Epstein, PhD, SUNY-University at Buffalo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2025
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2030
Study Registration Dates
First Submitted
October 24, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Actual)
November 17, 2025
Study Record Updates
Last Update Posted (Actual)
November 17, 2025
Last Update Submitted That Met QC Criteria
November 13, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00008702
- 1R01DK139258-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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