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Genetic Predisposition to Food Cue Reactivity in Children

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ClinicalTrials.gov Identifier: NCT03766191
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Dartmouth College
Information provided by (Responsible Party):
Diane Gilbert-Diamond, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Food Ads Other: Non-food Ads Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Relation of Genetic Factors, Food Cues, and Self-Regulation With Excess Consumption and Adiposity in Children
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Active Comparator: Food Ads and fMRI Behavioral: Food Ads
Exposure to foods ads that are embedded in an age-appropriate TV program

Sham Comparator: Non-Food Ads and fMRI Other: Non-food Ads
Exposure to non-food ads that are embedded in an age-appropriate TV program

Active Comparator: Food Ads and TV show Behavioral: Food Ads
Exposure to foods ads that are embedded in an age-appropriate TV program

Sham Comparator: Non-Food Ads and TV show Other: Non-food Ads
Exposure to non-food ads that are embedded in an age-appropriate TV program




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766191


Contacts
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Contact: Reina K Lansigan, MSSW 917-915-3686 reina.k.lansigan@dartmouth.edu

Locations
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United States, New Hampshire
Dartmouth-Hitchcock Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Reina K Lansigan, MSSW         
Principal Investigator: Diane Gilbert-Diamond, ScD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Dartmouth College
Investigators
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Principal Investigator: Diane Gilbert-Diamond, ScD Dartmouth-Hitchcock Medical Center

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Responsible Party: Diane Gilbert-Diamond, Associate Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03766191     History of Changes
Other Study ID Numbers: D19064
1R01HD092604 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diane Gilbert-Diamond, Dartmouth-Hitchcock Medical Center:
Obesity
Cue Reactivity
Genetics
Self Regulation
fMRI
Children
Eating in the Absence of Hunger
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms