Food Genetics Behavior Study (FOODIE)

Role of Energy Balance Behaviors in Modifying Biobehavioral Risk Factors for Childhood Obesity

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Heightened Drive to Eat

Detailed Description

This study examines the interplay between genotype and phenotype and assesses if energy balance behaviors in the context of the family environment, alone or in combination, can modify behavioral and genetic predispositions to childhood obesity. The research aims to prospectively evaluate the extent to which associations of a heightened drive to eat (HDE) on 1-year changes in weight and adiposity outcomes are independent or additive to those of a genetic risk for obesity among children. In addition, the study aims to prospectively examine risk-modifying energy balance behaviors in areas of diet, physical activity, and sleep that may mitigate the detrimental impact of a HDE or high genetic risk on weight and adiposity outcomes and test whether these factors differ for HDE versus a high genetic risk of obesity on those outcomes. Lastly, the research aims to examine the impact of family-level influences in areas of family functioning and parent feeding on risk-modifying energy balance behaviors in children.

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zenas Okero; Phone Number: (215) 746-2061; Email: zokero@nursing.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Medicine Center for Weight and Eating Disorders
      • Contact: Ana Coronado
      • Principal Investigator: Tanja VE Kral, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heightened Drive to Eat; Eating rate; Eating in the absence of hunger; Relative reinforcing value of food	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: 852728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No