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NCT Number: NCT05783765

Food Genetics Behavior Study

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.

Recruiting

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Ana Coronado

CONTACT

Tanja VE Kral, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heightened Drive to Eat

Behavioral

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 outcomes

  1. Body Mass Index (BMI)

    Time frame: Change from baseline to 1-year follow-up

    BMI z-score

  2. Waist circumference

    Time frame: Change from baseline to 1-year follow-up

    Abdominal waist circumference (cm)

  3. Body fat

    Time frame: Change from baseline to 1-year follow-up

    Body fat percentage

Study contacts

Contact information is provided by the study sponsor or research team.

Zenas Okero

CONTACT

[email protected]

(215) 746-2061

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: FOODIE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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