Brain and Behavior Influences on Obesity Development From Infancy Through Childhood (RESONATE)

May 5, 2026 updated by: Johns Hopkins University

Early Brain Development and Child Nutrition and Obesity

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity risk shows individual variation such that some children are more likely than others to gain excess weight. One potential reason is that, due to genetic and environmental factors, individuals vary in appetitive behaviors that drive food intake and weight. However, the neurodevelopmental mechanisms underpinning variation in appetite and weight, and effects of risk and protective factors on those outcomes, are not understood. Preliminary data from RESONANCE, the investigators large MRI cohort, suggests obesity risk factors such as maternal pre-pregnancy obesity and obesity-associated genetic variants are associated with not just heightened parent-reported child appetite and adiposity, but with altered patterns of brain structure development from infancy through early childhood. However the relevance of these findings to appetitive behaviors and development of obesity in middle childhood is unknown. This is important because obesity rates and metabolic complications increase through development, adiposity and eating habits measured in later childhood track into adulthood, and obesity is harder to treat later in development, making middle childhood a key stage for capturing outcomes with relevance for lifetime metabolic health. Further, although functional magnetic resonance imaging (MRI) studies have identified altered patterns of activation in brain appetite circuits in association with pediatric obesity and early risk factors for obesity, the predictors of altered functioning of brain appetite circuits in middle childhood are unknown. Identifying the patterns of brain development that predict obesity-promoting behaviors and brain functioning in middle childhood is essential to understand the neural mechanisms by which early obesity risk factors drive excess intake and obesity, and may help pinpoint neurobehavioral targets for early obesity prevention. Finally, although preclinical research and MRI studies of children under 9 years of age support that hypothalamic gliosis, a cellular inflammatory response, plays a role in obesity pathogenesis, it is unclear whether it occurs or impacts appetite in earlier life. For the proposed study, RESONATE, the investigators will address the above research gaps by extending the RESONANCE study to administer meal tests, behavioral and functional magnetic resonance imaging (fMRI) tasks assessing food and non-food reward and cognitive control, and weight/ adiposity measures in middle childhood, and examining hypothalamic gliosis, in a sub-sample of RESONANCE children. By combining this data with extant MRI data and extant or newly-collected data on obesity risk and protective factors, the investigators will test a multi-faceted hypothesis that prenatal, genetic and postnatal factors lead to differential early development of brain appetite circuits, which in turn gives rise to variation in appetitive behaviors and behaviors involving reward processing and cognitive control as well as altered function of brain appetite circuits, that act to influence the development of obesity into middle childhood. The investigator's long-term goal is to lay foundations for developmentally-appropriate, neurobehaviorally-informed interventions to address child obesity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Active, not recruiting
        • Johns Hopkins University School of Medicine
      • Baltimore, Maryland, United States, 21205
        • Active, not recruiting
        • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Viren D'Sa, MD
        • Sub-Investigator:
          • Daphne Koinis-Mitchell, PhD
    • Washington
      • Seattle, Washington, United States, 98109
        • Active, not recruiting
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Study Population

Participants are drawn from the existing RESONANCE cohort. RESONANCE is a large community sample of families of children ranging from infancy through middle childhood.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single arm
Other: fMRI cue reactivity task
Measures effect of food and non-food cues on brain activation
Other: fMRI go no go task
Measures effect of food and non-food cues on inhibitory responses and brain activation
Other: Ad libitum meal test
Measures effect of exposure to multi-item buffet meal on food intake
Other: Eating in the absence of hunger test
Measures effect of exposure to palatable snacks on food intake

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Meal test intake as assessed by total kilocalories consumed
Time Frame: Day 1
Total kilocalories consumed. Once at the first study visit (lab visit)
Day 1
Weight/adiposity as assessed by BMI
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 1
Commission error rate. Once, at the first study visit (lab visit)
Day 1
Functioning in brain appetite circuits as assessed by cue reactivity task
Time Frame: During 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).
During MRI procedure
Functioning in brain appetite circuits as assessed by cognitive control task
Time Frame: During 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).
During MRI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Washington
Rhode Island Hospital
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Carnell, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00118376
  • R01DK136602 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

RESONATE is a sub-study within a sub-sample drawn from the RESONANCE cohort, supported by NIH's ECHO initiative. RESONANCE data used for RESONATE will include data on anthropometrics, parent-report appetitive behaviors, executive functioning, child diet, food parenting, maternal pre-pregnancy body weight, sociodemographic characteristics, common genetic variants, and brain MRI measures. For RESONATE, additional data including behavioral task responses, data from eating behavior tests, structural and functional brain MRI measures, and survey responses including measures of eating-disordered behaviors and food parenting, will be obtained in children assessed age 7-12 years. All RESONANCE data collected under the ECHO-wide protocol will be made publicly available via the National Institute of Child Health and Human Development Data and Specimen Hub. Data unique to the RESONATE sub-study will also be preserved and made available for sharing on request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings