Recruiting

Observational Study

Sponsor:

Temple University

Code:

NCT06111040

Conditions

Parenting

Eating Behavior

Diet, Healthy

Pediatric Obesity

Eligibility Criteria

Sex: All

Age: 4 - 5

Healthy Volunteers: Accepted

Interventions

Measurement

Study Details

Brief summary:

High food motivation among children is trait-like and increases risks of unhealthy dietary intake and obesity. Scientific knowledge of how parenting can best support healthy eating habits and growth among children who are predisposed to overeating is surprisingly limited. This investigation will identify supportive food parenting approaches for obesity prevention that address the needs of highly food motivated children.

Conditions

Parenting

Eating Behavior

Diet, Healthy

Pediatric Obesity

Study ID

NCT06111040

Start date

Sep 7, 2023

Status verified date

Nov, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 5

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Child ages 4 or 5 years at baseline;
2. Parent/ primary caregiver with legal representation (having 50% or more custody of child);
3. Parent/primary caregiver reporting primary responsibility for child feeding outside of childcare (being with child when they are eating at least two times daily);
4. Caregiver with a cell phone that can be used to send and receive text messages. If there is more than one age-eligible child in the family, we will ask the caregiver to pick the index child.

Exclusion Criteria:

1. Parent/primary caregiver <18 years of age;
2. Child history of major food allergies (e.g., peanuts);
3. Child medication use (e.g., insulin), developmental disability (e.g., autism) or medical condition(s) (e.g., diabetes) known to affect food intake and growth;
4. Foster child.

Study Design

Enrollment

416 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Caregiver-child dyads

A cohort of 205 caregivers and 205 children aged 4-5 years at baseline will be recruited and followed longitudinally for 18 months.

Interventions

Measurement

The only interventions are at the measurement level and consist of two behavioral protocols designed to assess children's eating behavior, where food stimuli are provided and children's behavioral responses are recorded.

Primary outcome measure

  • Excessive dietary intakes [ Time Frame: Baseline, 18 months ]
  • BMI change [ Time Frame: Baseline, 18 months ]

Central Contacts and Locations

Central contacts

Locations

Temple University - Center for Obesity Research and Education

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

USDA/ARS Children's Nutrition Research Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Temple University

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Temple University on 2025-11-05.