Food Genetics Behavior Study

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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.

Conditions:

🦠 Obesity, Childhood

🗓️ Study Start (Actual) 17 July 2023

🗓️ Primary Completion (Estimated) October 2026

✅ Study Completion (Estimated) October 2027

👥 Enrollment (Estimated) 56

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

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

Ages Eligible for Study: 5 Years to 7 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 13 March 2023
First Submitted that Met QC Criteria 13 March 2023
First Posted 24 March 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 13 November 2023
Last Update Posted 14 November 2023
Last Verified November 2023