FOODIE: Food Genetics Behavior Study

Sponsor

University of Pennsylvania (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05783765

Collaborator

(none)

302

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Childhood	Behavioral: Heightened Drive to Eat	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

302 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Oct 1, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT05783765

Other Study ID Numbers:

852728

First Posted:

Mar 24, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Study Results

No Results Posted as of Mar 31, 2023