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NCT02390765 · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Children s Growth and Behavior Study

What this study is about

Background: \- Studies show that many factors affect children's eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns. Objective: \- To understand how genes and environment influence eating behavior and health over time.

View original scientific description

Background: \- Studies show that many factors affect children's eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns. Objective: \- To understand how genes and environment influence eating behavior and health over time. Eligibility: \- Children ages 8-17 in good general health. Design: * Screening visit 1: Medical history, physical exam, body measurements, and questions. * 14 days: Participants will wear a wrist monitor and answer smartphone prompts about eating and mood. They may give a stool sample. * Screening visit 2: * Body measurements. * Saliva, urine, and blood samples. * Heart tests. * Meals provided (after fasting overnight). * Questionnaires and interview. * Behavior, thinking, and exercise tests. * X-ray of left wrist and full body.\<TAB\> * Some parents may have medical history, physical exam, and questions at screening visits. They may answer questions at the yearly visits. * Participants will have up to 6 yearly visits. They will give a urine sample and body measurements, and repeat the X-rays. They will have questions and behavior and thinking tasks. They may give stool samples. Visits will range from 3 to 8 hours. * Participants may choose to participate in other studies: * Stress and Hormones, 1 visit: While resting, participants will give saliva samples and have their heart monitored. Then they will do math. They will repeat the resting part, then do a computer task. * Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on their head then answer questions. Once, they will have an MRI, lying still in a scanner with a coil on their head. Before the first visit, participants will collect at-home saliva samples once a day for three days. During both visits, participants will perform tasks and answer questions that gauge their thinking skills and mood. * Experiment 3 (sleep/fatigue): Participants will complete 2 additional visits. During these visits, participants will complete a task on the computer for 2 hours, or watch a movie for two hours. After completion of the task/movie, they will answer questions and be provided with food. Participants will be compensated for the time and inconvenience involved with completing study procedures.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Parents/Guardians will qualify if they meet the following criteria.
  • Age \>=18 years
  • Have a child enrolled in this protocol (15-CH-0096).

Exclusion criteria

  • Parents/Guardians will be excluded for the following reasons:
  • If their child is not eligible to participate in the study (see below)
  • 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.

Where

  • Bethesda, Maryland

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations

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RECRUITING

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Maryland

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Obesity Treatment Options in Bethesda, Maryland

If you're searching for Obesity treatment in Bethesda, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Bethesda and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Obesity. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Maryland
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Up to 1500 participants
Quick Start
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Why Consider a Clinical Trial for Obesity?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Obesity

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Obesity Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT02390765. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.