Children s Growth and Behavior Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02390765|
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : September 10, 2019
- 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.
- To understand how genes and environment influence eating behavior and health over time.
- Children ages 8 17 in good general health.
- 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.
- Sleep, 2 visits: Participants will have food provided, answer questions and do tasks.
Participants will be compensated for the time and inconvenience involved with completing study procedures.
|Condition or disease|
|Obesity Eating Behaviors Healthy Volunteers|
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||Children's Growth and Behavior Study|
|Actual Study Start Date :||April 21, 2015|
|Estimated Primary Completion Date :||December 12, 2028|
|Estimated Study Completion Date :||December 12, 2028|
All participants in the study will be evaluated as one group
- Differences in eating behavior [ Time Frame: up to years of follow-up ]Multiple outcome measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390765
|Contact: Deborah R Altman||(301) email@example.com|
|Contact: Jack A Yanovski, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Jack A Yanovski, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|