Long-Term study aims to uncover why kids develop unhealthy eating habits
NCT ID NCT02390765
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 8 times
Summary
This study follows 1,500 children ages 8 to 17 over several years to learn how genes, sleep, mood, and environment affect eating behavior and overall health. Participants wear wrist monitors, answer smartphone surveys, and provide samples like blood and stool. The goal is to identify early risk factors for obesity and eating-related problems, not to test a treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help identify early risk factors for obesity and eating disorders, leading to better prevention strategies.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly test any therapy, and results may take years to translate into practical advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2015
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
community sample
- Ages
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8 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* Eligibility Criteria for Parents/Guardians of Child Participants: INCLUSION CRITERIA: Parents/Guardians will qualify if they meet the following criteria. 1. Age \>=18 years 2. Have a child enrolled in this protocol (15-CH-0096). EXCLUSION CRITERIA: Parents/Guardians will be excluded for the following reasons: 1. If their child is not eligible to participate in the study (see below) 2. If they are believed by the medical study team to have a medical or psychiatric problem that will not allow them to complete study procedures safely (these will be determined on a case-by-case basis) Eligibility Criteria for Child Participants: INCLUSION CRITERIA: Volunteers will qualify if they meet the following criteria. * 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 CRITERIA: Individuals will be excluded (and provided treatment referrals as needed) for the following reasons: * 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). Additional exclusions for (optional) stool sample collection include: Stool Sample only: * 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. In addition, Experiments 1 and 2 have specific additional exclusions: Experiment 1 only: * 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). Experiment 2 only: * 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. All participants will receive a written explanation of the purposes, procedures, and potential hazards of the study. Communication of this information and of the participant's assent as well as the consent of the parent or guardian will be documented in the medical record and copies of all signed documents given to each family. All participants will be informed of their right to withdraw from the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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