Children s Growth and Behavior Study
Children's Growth and Behavior Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 8 Years to 100 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 6 visits, 1 visit, 2 visits
- Time periods mentioned: 3 days, 2 weeks
- Procedures mentioned: Physical exams, Blood draws, X-rays, Questionnaires, Interviews, Urine samples, MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- "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."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how genes and surroundings affect children's eating habits and health over time. It is for children ages 8–17 who are generally healthy, including children who are overweight. Children may have up to 6 yearly follow-up visits.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Children must be ages 8–17 when they join. They may stay in the study as adults.
- Weight, height, and BMI (a measure of weight compared with height) must each be at or above the 5th percentile for age and sex.
- Children must be able to complete study tasks and have an overall IQ score of at least 70.
- Children must be generally healthy. Being overweight or having a minor, well-controlled illness is allowed.
- Parents or guardians who join must be at least 18 and have a child enrolled in this study.
Who can't join
- Major heart disease, serious weight-related health problems such as high blood pressure or diabetes, or other major illnesses affecting organs, hormones, blood, or lungs.
- Regular use of medicines that affect weight or eating, or regular use of tobacco or alcohol. Medicines for minor problems are reviewed case by case.
- Current or past pregnancy, or losing more than 5% of body weight in the past 3 months. Girls who have started their periods need a negative pregnancy test.
- A serious or recent head injury, or a major mental health disorder that meets the study's exclusion rules. Other mental health symptoms may be allowed.
- Any condition in the child or parent that could prevent study completion. Parents cannot join if their child is not eligible or if their own health makes study tasks unsafe.
- Optional stool samples: certain bowel diseases, diarrhea in the past week, or antibiotics in the past 4 weeks.
- Optional stress and hormone study: certain medicines that affect nerves or hormones, or an activity score rated as highly active.
- Optional brain imaging study: being left-handed or having metal, implants, braces, or certain tattoos that make the scans unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* 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.
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Study contact · 800-411-1222 ext. TTY dial 711 · ccopr@nih.govMore trials in Bethesda