Children's Growth and Behavior Study
概览
- 阶段
- 不适用
- 干预措施
- All pediatric participants
- 疾病 / 适应症
- Obesity
- 发起方
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 入组人数
- 1500
- 试验地点
- 1
- 主要终点
- Differences in eating behavior of pediatric participants
- 状态
- 招募中
- 最后更新
- 3天前
概览
简要总结
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.
详细描述
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 parents/caregivers. 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.
研究者
入排标准
入选标准
- •Eligibility Criteria for Parents/Guardians of Child Participants:
- •INCLUSION CRITERIA:
- •Parents/Guardians will qualify if they meet the following criteria.
- •Age \>=18 years
- •Have a child enrolled in this protocol (15-CH-0096).
排除标准
- •Parents/Guardians will be excluded for the following reasons:
- •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)
- •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).
研究组 & 干预措施
All pediatric participants
All pediatric participants in the study will be evaluated as one group
Parents of participants
Parents provide information about their children and supply DNA / blood samples for future analyses
结局指标
主要结局
Differences in eating behavior of pediatric participants
时间窗: up to 6 years of follow-up
Multiple outcome measures
次要结局
- Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest(During social threat attention bias paradigm)
- Experiment 3 (Sleep/fatigue): fatigue and task resistance(Immediately before and after completion of the computer task and movie (approximately 2hours))
- Experiment 3 (Sleep/fatigue): behavioral performance(During the computer task (~2hours).)
- Experiment 3 (Sleep/fatigue): energy intake.(Immediately following completion of the computer task and movie.)
- Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest and food intake in the laboratory(During palatable (vs non-palatable) food cues attention bias paradigm)
- Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest(During palatable (vs non-palatable) food cues attention bias paradigm)