Obesity and OverweightRESONATENCT06861868
Brain and Behavior Influences on Obesity Development From Infancy Through Childhood
A study testing fMRI cue reactivity task, fMRI go no go task and Ad libitum meal test in people with Obesity and Overweight, run by Johns Hopkins University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- fMRI cue reactivity task, fMRI go no go task and Ad libitum meal test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Dec 2024to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 1 recruiting
- Active, not recruiting
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Baltimore, Maryland, 21205
- Active, not recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Viren D'Sa, MD, 312-371-4178, viren_dsa@brown.edu
Daphne Koinis-Mitchell, PhD, 401-793-8632, daphne_koinis-mitchell@brown.edu
- Active, not recruiting
University of Washington
Seattle, Washington, 98109
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity and Overweight
- Being tested
- fMRI cue reactivity task, fMRI go no go task, Ad libitum meal test, Eating in the absence of hunger test
- Keywords
- obesity, overweight, pediatric, eating behavior, appetite, neuroimaging, magnetic resonance imaging, brain development
- Medical subject headings
- Obesity, Overweight, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI cue reactivity taskOther
Measures effect of food and non-food cues on brain activation
fMRI go no go taskOther
Measures effect of food and non-food cues on inhibitory responses and brain activation
Ad libitum meal testOther
Measures effect of exposure to multi-item buffet meal on food intake
Eating in the absence of hunger testOther
Measures effect of exposure to palatable snacks on food intake
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Single arm Receives: Other: fMRI cue reactivity task; Other: fMRI go no go task; Other: Ad libitum meal test; Other: Eating in the absence of hunger test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meal test intake as assessed by total kilocalories consumed
Total kilocalories consumed. Once at the first study visit (lab visit)
Measured: Day 1
Weight/adiposity as assessed by BMI
Body Mass Index z-score. Once at the first study visit (lab visit)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: During MRI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start2 Dec 2024
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Rhode Island Hospital, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., University of Washington
- Responsible party
- Sponsor
- Investigators
- Susan Carnell, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861868
- Sponsor's protocol ID
- IRB00118376
- Other IDs
- R01DK136602
- Acronym
- RESONATE
- Status last verified
- May 2026
- First submitted
- 12 Feb 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Brain Development and Child Nutrition and Obesity
- ClinicalTrials.gov ID
- NCT06861868
- Acronym / sponsor ID
- RESONATE / IRB00118376
- Conditions
- Obesity and Overweight
- Keywords
- obesity, overweight, pediatric, eating behavior, appetite, neuroimaging, magnetic resonance imaging, brain development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Rhode Island Hospital, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., University of Washington
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Other: fMRI cue reactivity task, Other: fMRI go no go task, Other: Ad libitum meal test, Other: Eating in the absence of hunger testSingle arm |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI cue reactivity taskMeasures effect of food and non-food cues on brain activation | Other | Single arm |
| fMRI go no go taskMeasures effect of food and non-food cues on inhibitory responses and brain activation | Other | Single arm |
| Ad libitum meal testMeasures effect of exposure to multi-item buffet meal on food intake | Other | Single arm |
| Eating in the absence of hunger testMeasures effect of exposure to palatable snacks on food intake | Other | Single arm |
Primary outcome
Meal test intake as assessed by total kilocalories consumed
Time frame: Day 1
Total kilocalories consumed. Once at the first study visit (lab visit)
Weight/adiposity as assessed by BMI
Time frame: Day 1
Body Mass Index z-score. Once at the first study visit (lab visit)
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)
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)
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Carnell, PhD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI cue reactivity task, fMRI go no go task and Ad libitum meal test in people with Obesity and Overweight, run by Johns Hopkins University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Carnell, PhD (410-955-7192, susan.carnell@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meal test intake as assessed by total kilocalories consumed (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.