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Completed

NCT Number: NCT03766191

Genetic Predisposition to Food Cue Reactivity 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.

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Key information

Conditions

Childhood Obesity Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Self-Control Signs and Symptoms Social Behavior

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food Ads

Behavioral

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

Non-food Ads

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Trustees of Dartmouth College

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2018
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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