Genetic Predisposition to Food Cue Reactivity in Children

November 18, 2024 updated by: Diane Gilbert-Diamond, Trustees of Dartmouth College

The Relation of Genetic Factors, Food Cues, and Self-Regulation With Excess Consumption and Adiposity in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Food Ads and fMRI
Exposure to food ads during an fMRI scan
Behavioral: Food Ads
Exposure to foods ads embedded in an age-appropriate TV program
Sham Comparator: Non-Food Ads and fMRI
Exposure to non-food ads during an fMRI scan
Other: Non-food Ads
Exposure to non-food ads embedded in an age-appropriate TV program
Active Comparator: Food Ads and TV show
Exposure to food ads embedded in an age-appropriate TV program
Behavioral: Food Ads
Exposure to foods ads embedded in an age-appropriate TV program
Sham Comparator: Non-Food Ads and TV show
Exposure to non-food ads embedded in an age-appropriate TV program
Other: Non-food Ads
Exposure to non-food ads embedded in an age-appropriate TV program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food-cue-related neural activity
Time Frame: Baseline
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.
Baseline
Food-cue-related Eating in the Absence of Hunger (EAH)
Time Frame: Baseline, 2 weeks, 4 weeks
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.
Baseline, 2 weeks, 4 weeks
Change in BMI
Time Frame: Baseline, 1-year followup
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.
Baseline, 1-year followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trustees of Dartmouth College

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Dartmouth College

Investigators

  • Principal Investigator: Diane Gilbert-Diamond, ScD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

March 27, 2024

Study Completion (Actual)

March 27, 2024

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D19064
  • 1R01HD092604 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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