Genetic Predisposition to Food Cue Reactivity in Children

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03766191
• Other study ID #: D19064
• Secondary ID: 1R01HD092604
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 189
• Est. completion date: December 31, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Food Ads
Exposure to foods ads embedded in an age-appropriate TV program

Other:
• Non-food Ads
Exposure to non-food ads embedded in an age-appropriate TV program

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (150)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline, 2 weeks, 4 weeks
Primary	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.	Baseline, 1-year followup