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Food Genetics Behavior Study (FOODIE)

Primary Purpose

Obesity, Childhood

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heightened Drive to Eat
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn Medicine Center for Weight and Eating DisordersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heightened Drive to Eat

Arm Description

Eating rate Eating in the absence of hunger Relative reinforcing value of food

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)
BMI z-score
Waist circumference
Abdominal waist circumference (cm)
Body fat
Body fat percentage

Secondary Outcome Measures

Full Information

First Posted
March 13, 2023
Last Updated
July 24, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05783765
Brief Title
Food Genetics Behavior Study
Acronym
FOODIE
Official Title
Role of Energy Balance Behaviors in Modifying Biobehavioral Risk Factors for Childhood Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heightened Drive to Eat
Arm Type
Experimental
Arm Description
Eating rate Eating in the absence of hunger Relative reinforcing value of food
Intervention Type
Behavioral
Intervention Name(s)
Heightened Drive to Eat
Intervention Description
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 Measure Information:
Title
Body Mass Index (BMI)
Description
BMI z-score
Time Frame
Change from baseline to 1-year follow-up
Title
Waist circumference
Description
Abdominal waist circumference (cm)
Time Frame
Change from baseline to 1-year follow-up
Title
Body fat
Description
Body fat percentage
Time Frame
Change from baseline to 1-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Coronado
Phone
(215) 746-2061
Email
anacm@upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Malinchak
Phone
(215) 746-2061
Email
sarahmal@nursing.upenn.edu
Facility Information:
Facility Name
Penn Medicine Center for Weight and Eating Disorders
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Coronado
First Name & Middle Initial & Last Name & Degree
Tanja VE Kral, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Food Genetics Behavior Study

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