TrialGlobe

Clinical trial

Brain and Behavior Influences on Obesity Development From Infancy Through Childhood

Recruiting now · Not applicable · 1 countries · Registry ID NCT06861868

Recruiting nowNot applicableInterventional

What this study is about

The investigators project, RESONATE, aims to investigate why some children develop obesity. To do this it uses data on eating and eating-related behaviors, genetic and environmental factors, and brain structure and function. This data is collected in a sub-sample of RESONANCE, a large study of families of children from infancy through childhood. The results will lay foundations for the development of early interventions to prevent or treat obesity.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age7 Years to 12 Years
SexAll
Healthy volunteersAccepted
ConditionObesity and Overweight

Full registry criteria

Inclusion Criteria: * Participants from the RESONANCE cohort are eligible if the participant will reach 7-12 years of age during the proposed project period and have no food allergies. Exclusion Criteria: * Exclusion criteria for RESONANCE include: 1. In utero exposure to alcohol, cigarette, or illicit substances; 2. First trimester fetal US abnormalities; 3. Complicated pregnancy (e.g., pre-eclampsia); 4. Complicated delivery, including APGAR scores less than 8 and/or neonatal intensive care unit (NICU) admission; 5. History of neurological (e.g., epilepsy), psychiatric (e.g., anxiety or depression requiring treatment with medication) or developmental disorder (e.g., autism spectrum disorder (ASD), dyslexia); 6. Contraindications for MRI including metal in the body, claustrophobia.

Treatments and study arms

fMRI cue reactivity task

Other

Measures effect of food and non-food cues on brain activation

fMRI go no go task

Other

Measures effect of food and non-food cues on inhibitory responses and brain activation

Ad libitum meal test

Other

Measures effect of exposure to multi-item buffet meal on food intake

Eating in the absence of hunger test

Other

Measures effect of exposure to palatable snacks on food intake

Primary outcomes

Meal test intake as assessed by total kilocalories consumedDay 1

Total kilocalories consumed. Once at the first study visit (lab visit)

Weight/adiposity as assessed by BMIDay 1

Body Mass Index z-score. Once at the first study visit (lab visit)

Food-related reward as assessed by food-related delay discounting taskDay 1

Number of trials the child passes. Once, at the first study visit (lab visit)

Food-related cognitive control as assessed by food-related go/no-go taskDay 1

Commission error rate. Once, at the first study visit (lab visit)

Functioning in brain appetite circuits as assessed by cue reactivity taskDuring MRI procedure

Activation of striatal reward regions and fronto-cingulate control circuits during task assessing food-related reward (cue reactivity). Once, at the second study visit (MRI visit).

Functioning in brain appetite circuits as assessed by cognitive control taskDuring MRI procedure

Activation of striatal reward regions and fronto-cingulate control circuits during task assessing food-related cognitive control (go/no go). Once, at the second study visit (MRI visit).

Study locations

4 locations were listed when this page was built. The first 40 are shown.

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.🇺🇸 Baltimore, Maryland, United States
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Johns Hopkins University School of Medicine🇺🇸 Baltimore, Maryland, United States
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Rhode Island Hospital🇺🇸 Providence, Rhode Island, United States
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Viren D'Sa, MDContact
Email · Call 312-371-4178
Daphne Koinis-Mitchell, PhDContact
Email · Call 401-793-8632
Viren D'Sa, MDPrincipal Investigator
University of Washington🇺🇸 Seattle, Washington, United States
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