NCT07229508

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Nov 2025

Longer than P75 for all trials

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 Progress10%
Nov 2025Oct 2030

First Submitted

Initial submission to the registry

October 24, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

November 6, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

4.9 years

First QC Date

October 24, 2025

Last Update Submit

November 13, 2025

Conditions

Keywords

Reinforcer Pathology TheoryReinforcing ValueDelay Discounting

Outcome Measures

Primary Outcomes (3)

  • zBMI

    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

    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

    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

Study Arms (2)

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

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Male and female children of varying racial/ethnic backgrounds, SES backgrounds, and varying body compositions

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14214, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Leonard H Epstein, PhD

    SUNY-University at Buffalo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary J Hite, BA

CONTACT

Katelyn Carr, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2025

First Posted

November 17, 2025

Study Start

November 6, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations