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Genetic Predisposition to Food Cue Reactivity in Children

Primary Purpose

Childhood Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Ads
Non-food Ads
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Obesity, Cue Reactivity, Genetics, Self Regulation, fMRI, Children, Eating in the Absence of Hunger

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English fluency
  • Willingness to participate in all study visits

Exclusion Criteria:

  • Relevant food allergies or dietary restrictions
  • Metal in or on the body
  • Claustrophobia
  • Psychiatric and neurological disorders
  • Relative in the study
  • Appetite- or attention-altering medications or disorders

Sites / Locations

  • Dartmouth-Hitchcock

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

Food Ads and fMRI

Non-Food Ads and fMRI

Food Ads and TV show

Non-Food Ads and TV show

Arm Description

Exposure to food ads during an fMRI scan

Exposure to non-food ads during an fMRI scan

Exposure to food ads embedded in an age-appropriate TV program

Exposure to non-food ads embedded in an age-appropriate TV program

Outcomes

Primary Outcome Measures

Food-cue-related neural activity
Activation in brain reward regions in response to food vs. non-food cues, as measured by differences in the blood-oxygen-level dependent response during fMRI scans. Investigators will examine associations between polymorphisms in FTO, MC4R, as well as a genetic risk score with the differential neural activity.
Food-cue-related Eating in the Absence of Hunger (EAH)
Difference in kcals consumed in response to food vs. non-food cue exposure in the behavioral sessions. Investigators will examine how differential neural activity in response to food vs. non-food cues will relate to EAH. Investigators will also assess whether self-regulatory capacity diminishes this association between differential neural activity and EAH.
Change in BMI
Difference between BMI z-score according to the Center for DiseaSe Control 2000 Growth Reference Curves assessed at baseline and follow-up. Investigators will assess the associations between genetic factors (polymorphisms in FTO, MC4R; and a genetic obesity risk score), food-cue-related neural activity and EAH with change in BMI.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2018
Last Updated
August 21, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Dartmouth College
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1. Study Identification

Unique Protocol Identification Number
NCT03766191
Brief Title
Genetic Predisposition to Food Cue Reactivity in Children
Official Title
The Relation of Genetic Factors, Food Cues, and Self-Regulation With Excess Consumption and Adiposity in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Dartmouth College

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 assesses the associations between genetic factors, food-cue-related neural reactivity, self-regulatory capacity, eating in the absence of hunger (EAH), and adiposity gain in children.
Detailed Description
The investigators will assess the associations between genetic factors, food-cue-related neural reactivity, eating in the absence of hunger (EAH) in response to food cues, and adiposity gain in children. They will also determine whether self-regulatory capacity modifies these associations. The genetic factors explored specifically include FTO, MC4R, polymorphisms in genes involved in dopaminergic pathways, and a composite genetic risk score built from genome-wide obesity-related loci. [3/14/2020]: Study recruitment temporarily halted due to the COVID-19 pandemic

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Obesity, Cue Reactivity, Genetics, Self Regulation, fMRI, Children, Eating in the Absence of Hunger

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Food Ads and fMRI
Arm Type
Active Comparator
Arm Description
Exposure to food ads during an fMRI scan
Arm Title
Non-Food Ads and fMRI
Arm Type
Sham Comparator
Arm Description
Exposure to non-food ads during an fMRI scan
Arm Title
Food Ads and TV show
Arm Type
Active Comparator
Arm Description
Exposure to food ads embedded in an age-appropriate TV program
Arm Title
Non-Food Ads and TV show
Arm Type
Sham Comparator
Arm Description
Exposure to non-food ads embedded in an age-appropriate TV program
Intervention Type
Behavioral
Intervention Name(s)
Food Ads
Intervention Description
Exposure to foods ads embedded in an age-appropriate TV program
Intervention Type
Other
Intervention Name(s)
Non-food Ads
Intervention Description
Exposure to non-food ads embedded in an age-appropriate TV program
Primary Outcome Measure Information:
Title
Food-cue-related neural activity
Description
Activation in brain reward regions in response to food vs. non-food cues, as measured by differences in the blood-oxygen-level dependent response during fMRI scans. Investigators will examine associations between polymorphisms in FTO, MC4R, as well as a genetic risk score with the differential neural activity.
Time Frame
Baseline
Title
Food-cue-related Eating in the Absence of Hunger (EAH)
Description
Difference in kcals consumed in response to food vs. non-food cue exposure in the behavioral sessions. Investigators will examine how differential neural activity in response to food vs. non-food cues will relate to EAH. Investigators will also assess whether self-regulatory capacity diminishes this association between differential neural activity and EAH.
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Change in BMI
Description
Difference between BMI z-score according to the Center for DiseaSe Control 2000 Growth Reference Curves assessed at baseline and follow-up. Investigators will assess the associations between genetic factors (polymorphisms in FTO, MC4R; and a genetic obesity risk score), food-cue-related neural activity and EAH with change in BMI.
Time Frame
Baseline, 1-year followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English fluency Willingness to participate in all study visits Exclusion Criteria: Relevant food allergies or dietary restrictions Metal in or on the body Claustrophobia Psychiatric and neurological disorders Relative in the study Appetite- or attention-altering medications or disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Gilbert-Diamond, ScD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Genetic Predisposition to Food Cue Reactivity in Children

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