NCT06111040

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Sep 2023Oct 2027

Study Start

First participant enrolled

September 7, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

4.2 years

First QC Date

October 26, 2023

Last Update Submit

November 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Excessive dietary intakes

    Indicators: SFAS intakes and meal/snack sizes estimated from 24-hour dietary recalls

    Baseline, 18 months

  • BMI change

    % of the 50th percentile per age- and sex-specific CDC reference values for BMI on a log scale

    Baseline, 18 months

Secondary Outcomes (1)

  • Observed food motivated behaviors

    Baseline, 18 months

Study Arms (1)

Caregiver-child dyads

OTHER

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

Other: Measurement

Interventions

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.

Also known as: Eating in the absence of hunger, Relative reinforcing value of food
Caregiver-child dyads

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child ages 4 or 5 years at baseline;
  • Parent/ primary caregiver with legal representation (having 50% or more custody of child);
  • Parent/primary caregiver reporting primary responsibility for child feeding outside of childcare (being with child when they are eating at least two times daily);
  • 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.

You may not qualify if:

  • Parent/primary caregiver \<18 years of age;
  • Child history of major food allergies (e.g., peanuts);
  • 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;
  • Foster child.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Temple University - Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

USDA/ARS Children's Nutrition Research Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • Buttner C, Skupin A, Reimann T, Rieber EP, Unteregger G, Geyer P, Frank KH. Local production of interleukin-4 during radiation-induced pneumonitis and pulmonary fibrosis in rats: macrophages as a prominent source of interleukin-4. Am J Respir Cell Mol Biol. 1997 Sep;17(3):315-25. doi: 10.1165/ajrcmb.17.3.2279.

    PMID: 9308918BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorPediatric Obesity

Interventions

Weights and MeasuresEating

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative TechniquesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Jennifer O Fisher, PhD

    Temple University

    PRINCIPAL INVESTIGATOR
  • Sheryl O Hughes, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Croce, MS

CONTACT

Nilda Micheli, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Family-based, prospective observational study with interventions at the measurement level
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

September 7, 2023

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

November 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Research data generated by the project will be supported by TUScholarShare (https://scholarshare.temple.edu/), the institutional repository for Temple University. This is a repository service that is managed by the Temple University Libraries and uses Open Repository, an enhanced DSpace platform that is hosted by Atmire. TUScholarShare has been developed with the intent of helping researchers comply with grant-funding agency requirements. It enables dissemination and long-term preservation and curation (management, use, and re-use) of data.

Time Frame
Within two years of completion of the study
Access Criteria
Researchers will work with the University Libraries Research Data Management Services staff to facilitate the deposit of data into TUScholarShare, and to ensure appropriate metadata and complete documentation of the data to maximize the ability to understand and reuse the data. The data will be published in TUScholarShare for long-term preservation, using services such as file format migration where possible, persistent identifiers (DOIs), persistent Web addresses (handles), and checksums. TUScholarShare data resides in two locations, a local Isilon storage system and an off-site cloud-based service, Open Repository. Open Repository's AWS cloud storage service provides extended infrastructure, which includes a production server, test server, fallback servers, data backups, and full system backups
More information

Locations