Children s Growth and Behavior Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-100
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >=18 years
Have a child enrolled in this protocol (15-CH-0096).
Disqualifiers
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)
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.
Trial population
community sample
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 2 trial groupsGroup A: All pediatric participants
Group B: Parents of participants
Trial outcomes
Primary outcomes
1
Differences in eating behavior of pediatric participants
Multiple outcome measures
Time frame
up to 6 years of follow-upSecondary outcomes
1
Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest and food intake in the laboratory
Explore whether gonadal hormone concentrations moderate the association between activation in ROIs and LOC-eating in the laboratory. Hyp 3a: The associations among activation in ROIs and LOC-eating severity will be stronger among girls with higher concentrations of estradiol. Hyp 3a: The associations among activation in ROIs and total energy intake will be stronger among girls with higher concentrations of estradiol. Hyp 3c: The associations among activation in ROIs and LOC-eating severity will be stronger among boys with lower concentrations of testosterone. Hyp 3d: The associations among activation in ROIs and total energy intake will be stronger among boys with lower concentrations of testosterone.
Time frame
During palatable (vs non-palatable) food cues attention bias paradigm2
Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest and food intake in the laboratory
Investigate if model-based decision making mediates the link between activation in ROIs while attending to images of food and LOC-eating in the laboratory. Hyp 2a: Model-based decision making (DM) will mediate the association between activation in all ROIs and severity of LOC-eating. Hyp 2a: Model-based DM will mediate the association between activation in all ROIs and total energy intake.
Time frame
During palatable (vs non-palatable) food cues attention bias paradigm3
Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest
Examine if activation in neural regions of interest (ROIs; striatum, prefrontal cortex, and hippocampus) while attending to food images is linked to decision making (DM) during a decision-making task. Hyp 1a: Striatum activation will be related to model-free learning. Hyp 1b: Activation in all ROIs will be linked to model-based learning.
Time frame
During palatable (vs non-palatable) food cues attention bias paradigm4
Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest
Differences in neural activity in youth with- and without Loss of Control Eating. In the model examining the initial attention capture period of the palatable food attention bias paradigm, condition will be coded as high-palatable food, low-palatable food, and neutral non-food trials. In the model examining the sustained attention deployment period of the palatable food attention bias paradigm, the conditions will be coded as high palatable-congruent and -incongruent trials, as well as low palatable-congruent and -incongruent trials.
Time frame
During palatable (vs non-palatable) food cues attention bias paradigmSponsors and contacts
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Source ClinicalTrials.gov