NCT05783765

Brief Summary

A genetic risk for obesity does not always translate to the development of obesity among children, which points to the presence of risk-modifying factors that likely relate to energy balance behaviors as key behavioral drivers. Using an integrated approach to comprehensively examine the interplay between genotype and phenotype, this study will systematically assess the extent to which energy balance behaviors, alone or in combination, in conjunction with family-level influences can modify behavioral and genetic predispositions to childhood obesity in a high-risk sample of predominantly minority children from low-resource backgrounds. Identifying protective factors that may mitigate the impact of obesity risk on weight and adiposity outcomes is critical for moving the prevention of childhood obesity into a new direction.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Jul 2023

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress66%
Jul 2023Oct 2027

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 26, 2023

Completed
4.3 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

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

4.3 years

First QC Date

March 13, 2023

Last Update Submit

October 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Body Mass Index (BMI)

    BMI z-score

    Change from baseline to 1-year follow-up

  • Waist circumference

    Abdominal waist circumference (cm)

    Change from baseline to 1-year follow-up

  • Body fat

    Body fat percentage

    Change from baseline to 1-year follow-up

Study Arms (1)

Heightened Drive to Eat

EXPERIMENTAL

* Eating rate * Eating in the absence of hunger * Relative reinforcing value of food

Behavioral: Heightened Drive to Eat

Interventions

Participants' eating rate and eating in the absence of hunger will be assessed during a videotaped experimental meal. The relative reinforcing value of food will be assessed using a computerized behavioral choice task.

Heightened Drive to Eat

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children
  • Children ages 5-7 years
  • Children with BMI equal to or greater 5th percentile
  • Mother must be children's biological mother and primary caregiver
  • Mother must be able to read and understand English

You may not qualify if:

  • Children with serious medical conditions or medication use known to affect food intake, body weight, physical activity, or sleep
  • Children with developmental and/or psychiatric conditions that may impact study compliance
  • Children with food allergies related to study foods or lactose intolerance
  • Children with low preference for study foods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Medicine Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

July 26, 2023

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations