Children s Growth and Behavior Study
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study ID
- NCT02390765
- Status
- Recruiting
Conditions
- Eating Behaviors
- Healthy Volunteers
- Obesity
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 100 Years
- Healthy Volunteers
- Accepted
Study Details
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 Dates
- Start date
- Apr 21, 2015
- Status verified
- May 2026
- Primary completion
- Dec 12, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 1,500 participants (estimated)
Arms
- Arm: All pediatric participantsAll pediatric participants in the study will be evaluated as one group
- Arm: Parents of participantsParents provide information about their children and supply DNA / blood samples for future analyses
Primary Outcome Measure
Differences in eating behavior of pediatric participants [ Time Frame: up to 6 years of follow-up ]
Central Contacts
- Bobby K Cheon(301) 827-1857
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 |
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