Children s Growth and Behavior Study

Recruiting now

Conditions studied: Obesity, Eating Behaviors, Healthy Volunteers

In brief

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.

Key facts

Study ID: NCT02390765
Run by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
People needed: 1500
Starts: 2015-04-21
Expected to finish: 2030-12-31
Last updated by the study team: 2026-07-10

Who can join

Age: 8 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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