Ignite Creation Date:
2024-05-06 @ 3:51 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02390765
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2015-03-17
Brief Title:
Children s Growth and Behavior Study
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Childrens Growth and Behavior Study
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 bodyTAB
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
Experiment 3 sleepfatigue 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 taskmovie they will answer questions and be provided with food
Participants will be compensated for the time and inconvenience involved with completing study procedures
- 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 bodyTAB
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
Experiment 3 sleepfatigue 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 taskmovie they will answer questions and be provided with food
Participants will be compensated for the time and inconvenience involved with completing study procedures
Detailed Description:
This study aims to disentangle the varying disinhibited eating patterns or eating behavior endophenotypes that lead to excessive weight gain and obesity-related comorbidities in youth Extensive baseline evaluations including three separate experimental paradigms and annual follow-up assessments will assist with identifying biopsychosocial mechanisms that appear to increase risk for and maintain these eating behaviors and lead to weight gain Illumination of early risk factors for specific eating behavior endophenotypes and their associated health outcomes will inform the development of targeted interventions for pediatric obesity Participants for the current study will include 500 healthy obese and non-obese boys and girls 8 to 17yo at baseline and their parentscaregivers Youth will first complete two visits in order to ensure study eligibility and to evaluate self-regulatory motivational and neurocognitive factors that appear to be salient to the development and maintenance of disinhibited eating behavior including psychological distress sleep behavior food reinforcement reward sensitivity executive functioning attention bias and a range of related genetic and physiological factors Eating behavior will be observed in the laboratory using several validated paradigms For two weeks participants will monitor their sleep using wrist actigraphy as well as record their mood eating behavior and eating cognitions using smart phones via ecological momentary assessment methods Youth will then be invited to complete up to three separate experimental paradigms designed to further elucidate cognitive emotional and physiological processes associated with disinhibited eating behavior All participants will then complete annual evaluations of weight and adiposity for a total of six years with more extensive evaluations of self-regulatory motivational and neurocognitive functioning every three years Studying children and adolescents longitudinally will allow for examination of the independent and shared risk factors for pediatric disinhibited eating and excess weight Data from these evaluations will not only be used to test specific hypotheses but will also be hypothesis-generating in that they will inform the development of additional empirical questions and subsequent experiments Thus the current protocol will offer the flexibility to examine potentially critical contributions to weight gain in children as they continue their biopsychosocial development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-CH-0096 | None | None | None |