Food Genetics Behavior Study

Not Applicable

Recruiting

• Conditions: Obesity, Childhood
• Interventions: Behavioral: Heightened Drive to Eat

• Registration Number: NCT05783765
• Lead Sponsor: University of Pennsylvania

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.

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 Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Study Start: 2023-07-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heightened Drive to Eat	Heightened Drive to Eat	* Eating rate * Eating in the absence of hunger * Relative reinforcing value of food

Primary Outcome Measures

Name	Time	Method
Waist circumference	Change from baseline to 1-year follow-up	Abdominal waist circumference (cm)
Body Mass Index (BMI)	Change from baseline to 1-year follow-up	BMI z-score
Body fat	Change from baseline to 1-year follow-up	Body fat percentage

Trial Locations

Locations (1)

Penn Medicine Center for Weight and Eating Disorders; 🇺🇸 Philadelphia, Pennsylvania, United States