Clinical trial NCT05783765: Food Genetics Behavior Study
Official title: Role of Energy Balance Behaviors in Modifying Biobehavioral Risk Factors for Childhood Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 158
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Change from baseline to 1-year follow-up
measure: Waist circumference
timeFrame: Change from baseline to 1-year follow-up
measure: Body fat
timeFrame: Change from baseline to 1-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
References: