Brain and Behavior Influences on Obesity Development From Infancy Through Childhood

NCT06861868 | Recruiting DMC

• 2 other identifiers: IRB00118376R01DK136602
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Obesity and Overweight

Keywords

obesity; overweight; pediatric; eating behavior; appetite; neuroimaging; magnetic resonance imaging; brain development

Outcome Measures

Primary Outcomes (6)

• Meal test intake as assessed by total kilocalories consumed

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

  Day 1

• Weight/adiposity as assessed by BMI

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

  Day 1

• Food-related reward as assessed by food-related delay discounting task

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

  Day 1

• Food-related cognitive control as assessed by food-related go/no-go task

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

  Day 1

• Functioning in brain appetite circuits as assessed by cue reactivity task

  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).

  During MRI procedure

• Functioning in brain appetite circuits as assessed by cognitive control task

  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).

  During MRI procedure

Study Arms (1)

Single arm

OTHER

Single arm

Other: fMRI cue reactivity task; Other: fMRI go no go task; Other: Ad libitum meal test; Other: Eating in the absence of hunger test

Interventions

fMRI cue reactivity task OTHER

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

Single arm

fMRI go no go task OTHER

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

Single arm

Eating in the absence of hunger test OTHER

Measures effect of exposure to palatable snacks on food intake

Single arm

Ad libitum meal test OTHER

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

Single arm

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• In utero exposure to alcohol, cigarette, or illicit substances;
• First trimester fetal US abnormalities;
• Complicated pregnancy (e.g., pre-eclampsia);
• Complicated delivery, including APGAR scores less than 8 and/or neonatal intensive care unit (NICU) admission;
• 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);
• Contraindications for MRI including metal in the body, claustrophobia.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Rhode Island Hospital: collaborator
• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: collaborator
• University of Washington: collaborator

Study Sites (4)

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Baltimore, Maryland, 21205, United States

ACTIVE NOT RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

ACTIVE NOT RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

University of Washington

Seattle, Washington, 98109, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Feeding Behavior

Interventions

Eating

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Susan Carnell, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Carnell, PhD

CONTACT

410-955-7192; susan.carnell@jhmi.edu

Viren D'Sa, MD

CONTACT

312-371-4178; viren_dsa@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 6, 2025
• Study Start: December 2, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: RESONANCE data collected as part of the wider ECHO study is uploaded to ECHO's central databases on a regular basis and will be made available to the public after regular periodic datalocks as determined by the ECHO program. RESONATE data will be made available at the time of publication of those data and will be available for a minimum of five years after any publication on which it is based.
• Access Criteria: Data from RESONATE and RESONANCE will be available for investigators providing an Institutional Review Board (IRB)/Ethics approval or certification of exemption from IRB/Ethics review, and agreeing to the terms and conditions of a data use agreement. Data will be available for any purpose unless prohibited by the informed consent process. To request access to RESONANCE data collected as part of the wider ECHO study, researchers will request a DASH account and submit a Data Request Form. The NICHD DASH Data Access Committee will review the request and provide a response in approximately two to three weeks. Once granted access, researchers will be able to use the data for three years. RESONATE data can be requested from the PIs and will be reviewed on a rolling basis. To protect participants, the investigators will deidentify shared data to the greatest extent possible, using masked study identifiers and utilizing HIPAA-compliant procedures.

Locations

US (4)