Food Genetics Behavior Study

Obesity, Childhood Clinical Trial

— FOODIE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783765
• Other study ID #: 852728
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: October 2027

Study information

• Verified date: November 2023
• Source: University of Pennsylvania
• Contact: Ana Coronado
• Phone: (215) 746-2061
• Email: anacm[@]upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: October 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Penn Medicine Center for Weight and Eating Disorders	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	BMI z-score	Change from baseline to 1-year follow-up
Primary	Waist circumference	Abdominal waist circumference (cm)	Change from baseline to 1-year follow-up
Primary	Body fat	Body fat percentage	Change from baseline to 1-year follow-up