Food Genetics Behavior Study

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Body Mass Index (BMI) [Time frame: Change from baseline to 1-year follow-up]
• Waist circumference [Time frame: Change from baseline to 1-year follow-up]
• Body fat [Time frame: Change from baseline to 1-year follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Penn Medicine Center for Weight and Eating Disorders — Philadelphia

Identifiers

NCT: NCT05783765 · 852728

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗