Children s Growth and Behavior Study

Obesity Clinical Trial

Official title: Children's Growth and Behavior Study

Status Recruiting

Clinical Trial 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 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Eating Behaviors
• Healthy Volunteers
• Obesity

• NCT number: NCT02390765
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Lucy K Loch
• Phone: (301) 480-6906
• Email: lucy.loch@nih.gov
• Status: Recruiting
• Start date: April 21, 2015
• Completion date: December 31, 2030