Recruiting

Food Genetics

Sponsor:

University of Pennsylvania

Code:

NCT05783765

Conditions

Obesity, Childhood

Eligibility Criteria

Sex: All

Age: 5 - 7

Healthy Volunteers: Accepted

Interventions

Heightened Drive to Eat

Study Details

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.

Conditions

Obesity, Childhood

Study ID

NCT05783765

Start date

Jul 26, 2023

Status verified date

Oct, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 7

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

242 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Heightened Drive to Eat

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

Interventions

Heightened Drive to Eat

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.

Primary outcome measure

  • Body Mass Index (BMI) [ Time Frame: Change from baseline to 1-year follow-up ]
  • Waist circumference [ Time Frame: Change from baseline to 1-year follow-up ]
  • Body fat [ Time Frame: Change from baseline to 1-year follow-up ]

Central Contacts and Locations

Central contacts

Zenas Okero

(215) 746-2061zokero@nursing.upenn.edu

Locations

Penn Medicine Center for Weight and Eating Disorders

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Tanja VE Kral, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-10-30.