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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05783765
Other study ID # 852728
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 17, 2023
Est. completion date October 2027

Study information

Verified date November 2023
Source University of Pennsylvania
Contact Ana Coronado
Phone (215) 746-2061
Email anacm@upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date October 2027
Est. primary completion date October 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 7 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Penn Medicine Center for Weight and Eating Disorders Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Mass Index (BMI) BMI z-score Change from baseline to 1-year follow-up
Primary Waist circumference Abdominal waist circumference (cm) Change from baseline to 1-year follow-up
Primary Body fat Body fat percentage Change from baseline to 1-year follow-up
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