Children s Growth and Behavior Study

Last updated: May 14, 2026
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bulimia

Obesity

Healthy Volunteers

Treatment

N/A

Clinical Study ID

NCT02390765
150096
15-CH-0096
  • Ages 8-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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. 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

Inclusion

  • Eligibility Criteria for Parents/Guardians of Child Participants:

INCLUSION CRITERIA:

Parents/Guardians will qualify if they meet the following criteria.

  1. Age >=18 years

  2. Have a child enrolled in this protocol (15-CH-0096).

Exclusion

EXCLUSION CRITERIA:

Parents/Guardians will be excluded for the following reasons:

  1. If their child is not eligible to participate in the study (see below)

  2. If they are believed by the medical study team to have a medical or psychiatricproblem that will not allow them to complete study procedures safely (these will bedetermined 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 duringfollow-up).

  • Weight, height and BMI >= 5th percentile for age and sex according to Centersfor 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 (withthe exception of overweight and minor, well-controlled illnesses). EXCLUSION CRITERIA: Individuals will be excluded (and provided treatment referrals as needed) for thefollowing reasons:

  • History of major cardiovascular disease or any other serious obesity-relatedcomplication as assessed during history and physical exam. Individuals withuntreated or major illnesses relating to the endocrine and/or cardiovascularsystems are excluded because these illnesses will likely influence outcomes.Such obesity-related comorbidities include hypertension (defined by age- sex-and height- specific standards; and fasting hyperglycemia consistent withdiabetes (fasting glucose > 126 mg/dL).

  • Presence of other major illnesses: renal, hepatic, gastrointestinal, mostendocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism),hematological problems or pulmonary disorders (other than asthma not requiringcontinuous medication). Non-serious medical illnesses, such as seasonalallergies, will be reviewed on a case-by-case basis.

  • Regular use of any medication known to affect body weight or eating behavior (e.g., many medications prescribed for attention deficit hyperactivitydisorder, or ADHD). Medication use for non-serious conditions (e.g., acne) willbe considered on a case-by-case basis.

  • Current pregnancy or a history of pregnancy. A negative pregnancy test beforestarting the study will be required for postmenarcheal girls.

  • Current and regular use of tobacco products and/or alcohol.

  • A significant reduction in weight during the past three months, for any reason,exceeding 5% of body weight.

  • A history of significant or recent brain injury that may considerably influenceperformance on neurocognitive measures (i.e., any history of loss ofconsciousness >=30 minutes associated with a head injury, any history of memoryloss or hospitalization associated with a head injury, or >=2 concussionswithin last year).

  • Presence of any significant, full-threshold psychiatric disorder based on DSMcriteria such as schizophrenia, bipolar disorder, alcohol or substance abuse,anorexia or bulimia nervosa, or any disorder that, in the opinion of theinvestigators, would impede competence or compliance or possibly hindercompletion of the study. These individuals will not be permitted to enroll inthe current study and will be referred for treatment. Individuals who presentwith other psychiatric disorders, including sub-threshold psychiatricdisorders, will be permitted to enroll in the study. Sub-threshold psychiatricdisorders include symptoms that do not meet diagnostic threshold based on theDSM criteria for mental disorders, but which are nevertheless significantlyimpairing or distressing. If, based on the opinion of the investigators, aparticipant requires treatment for his/her psychiatric symptoms, the individualwill be referred for treatment. Participants who develop any psychiatricdisorder or significant psychiatric symptoms at any follow-up assessment duringthe study will not be excluded, but will be provided with treatment referrals.

  • Any other condition in the child or parents/guardians that, in the opinion ofthe investigators, would impede compliance or possibly hinder completion of thestudy (e.g., significant Learning Disorder). Additional exclusions for (optional) stool sample collection include: Stool Sample only:

  • Diagnosis or history of inflammatory bowel disease, including ulcerativecolitis or Crohn's disease, celiac sprue, irritable bowel syndrome, or otherinflammatory disorders of the intestine.

  • Diarrhea within 1 week prior to sampling.

  • Antibiotic use within 4 weeks prior to sampling. In addition, Experiments 1 and 2 have specific additional exclusions: Experiment 1 only:

  • Regular use of medications that could influence autonomic or endocrinefunctioning, including alpha and beta blockers, oral contraceptives, orprescription pain medication.

  • Scoring as "highly active" on the International Physical Activity Questionnaire (due to decreased cortisol reactivity). Experiment 2 only:

  • Participants will be excluded if MRI and MEG is contraindicated (metal in/onbody, braces, presence of non-organic [e.g., cochlear] implants or cerebralclips, permanent tattooed makeup or general tattoos that are recent and/or in adangerous location on the body or made with colors whose content in iron cannotbe definitely ruled out.

  • Youth will be excluded if they are left-handed. All participants will receive a written explanation of the purposes, procedures, andpotential hazards of the study. Communication of this information and of theparticipant's assent as well as the consent of the parent or guardian will bedocumented in the medical record and copies of all signed documents given to eachfamily. All participants will be informed of their right to withdraw from the study.

Study Design

Total Participants: 1500
Study Start date:
April 21, 2015
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • National Institutes of Health Clinical Center

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • National Institutes of Health Clinical Center

    Bethesda 4348599, Maryland 4361885 20892
    United States

    Site Not Available

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