Clinical trial NCT03766191: 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
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Obesity
Cue Reactivity
Genetics
Self Regulation
fMRI
Children
Eating in the Absence of Hunger
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Dartmouth College
First posted: 2018-12-06
Enrollment: 189
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Food-cue-related neural activity
timeFrame: Baseline
measure: Food-cue-related Eating in the Absence of Hunger (EAH)
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Change in BMI
timeFrame: Baseline, 1-year followup
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Diane Gilbert-Diamond, ScD
role: PRINCIPAL_INVESTIGATOR
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