Children's Growth and Behavior Study
This observational study, called the Children's Growth and Behavior Study, aims to understand how genes and environment affect children's eating behaviors and overall health over time. Researchers want to identify factors that might lead to excessive weight gain and obesity in young people. The study will follow children aged 8 to 17 years who are in good general health. Success will be measured by understanding differences in eating behavior over up to 6 years of follow-up. The current status of this study is unclear, and it plans to enroll 1500 participants.
- Study design
- This is an observational study, meaning participants will be observed without receiving specific interventions. It aims to enroll 1500 participants.
- What's involved
- Participants will have two screening visits, including medical history, physical exams, body measurements, and questions. They will wear a wrist monitor for 14 days, answer smartphone prompts, and may provide stool, saliva, urine, and blood samples, as well as undergo heart tests and eat provided meals after fasting.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 6 years to measure differences in eating behavior.
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NCT02390765
Children s Growth and Behavior Study
Recruiting
Not specifiedAges 8+ObservationalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Government-funded
~1,500 participants
Updated 2026-07-10 on ClinicalTrials.gov
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Differences in eating behavior of pediatric participants
Measured over up to 6 years of follow-up
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Bobby K Cheon · PRINCIPAL_INVESTIGATOR · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age 8-17 years (NB: children may continue to participate as adults during follow-up).
Weight, height and BMI \>= 5th percentile for age and sex according to Centers for Disease Control and Prevention 2000 US standards.
Cognitively capable of completing study procedures (FSIQ \>= 70).
Good general health based on a normal history and physical examination (with the exception of overweight and minor, well-controlled illnesses).
Exclusion
History of major cardiovascular disease or any other serious obesity-related complication as assessed during history and physical exam. Individuals with untreated or major illnesses relating to the endocrine and/or cardiovascular systems are excluded because these illnesses will likely influence outcomes. Such obesity-related comorbidities include hypertension (defined by age- sex- and height- specific standards; and fasting hyperglycemia consistent with diabetes (fasting glucose \> 126 mg/dL).
Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.
Regular use of any medication known to affect body weight or eating behavior (e.g., many medications prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.
Current pregnancy or a history of pregnancy. A negative pregnancy test before starting the study will be required for postmenarcheal girls.
Current and regular use of tobacco products and/or alcohol.
A significant reduction in weight during the past three months, for any reason, exceeding 5% of body weight.
A history of significant or recent brain injury that may considerably influence performance on neurocognitive measures (i.e., any history of loss of consciousness \>=30 minutes associated with a head injury, any history of memory loss or hospitalization associated with a head injury, or \>=2 concussions within last year).
Presence of any significant, full-threshold psychiatric disorder based on DSM criteria such as schizophrenia, bipolar disorder, alcohol or substance abuse, anorexia or bulimia nervosa, or any disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. These individuals will not be permitted to enroll in the current study and will be referred for treatment. Individuals who present with other psychiatric disorders, including sub-threshold psychiatric disorders, will be permitted to enroll in the study. Sub-threshold psychiatric disorders include symptoms that do not meet diagnostic threshold based on the DSM criteria for mental disorders, but which are nevertheless significantly impairing or distressing. If, based on the opinion of the investigators, a participant requires treatment for his/her psychiatric symptoms, the individual will be referred for treatment. Participants who develop any psychiatric disorder or significant psychiatric symptoms at any follow-up assessment during the study will not be excluded, but will be provided with treatment referrals.
Any other condition in the child or parents/guardians that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study (e.g., significant Learning Disorder).
Diagnosis or history of inflammatory bowel disease, including ulcerative colitis or Crohn's disease, celiac sprue, irritable bowel syndrome, or other inflammatory disorders of the intestine.
Diarrhea within 1 week prior to sampling.
Antibiotic use within 4 weeks prior to sampling.
Regular use of medications that could influence autonomic or endocrine functioning, including alpha and beta blockers, oral contraceptives, or prescription pain medication.
Scoring as "highly active" on the International Physical Activity Questionnaire (due to decreased cortisol reactivity).
Participants will be excluded if MRI and MEG is contraindicated (metal in/on body, braces, presence of non-organic \[e.g., cochlear\] implants or cerebral clips, permanent tattooed makeup or general tattoos that are recent and/or in a dangerous location on the body or made with colors whose content in iron cannot be definitely ruled out.
Youth will be excluded if they are left-handed.
What this trial measures
- Differences in eating behavior of pediatric participantsup to 6 years of follow-up
Multiple outcome measures