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Protocol Details

Children's Growth and Behavior Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-CH-0096

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 8 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Stress Response;
Binge Eating;
Eating Behavior;
Obesity;
Disordered Eating

Recruitment Keyword(s)

None

Condition(s)

Obesity;
Eating Behaviors;
Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Child Health and Human Development

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.

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Eligibility

INCLUSION CRITERIA:

Volunteers will qualify if they meet the following criteria.

-Age 8 17 years.

-Weight, height and BMI greater than or equal to 5th percentile for age and sex according to Centers for Disease Control and Prevention 2000 US standard.

-Cognitively capable of completing study procedures (FSIQ greater than or equal to 70).

-Good general health based on a normal history and physical examination (with the exception of overweight and minor, well-controlled illnesses).

EXCLUSION CRITERIA:

Individuals will be excluded (and provided treatment referrals as needed) for the following reasons:

-History of major cardiovascular disease or any other serious obesity-related complication as assessed during history and physical exam. Individuals with untreated or major illnesses relating to the endocrine and/or cardiovascular systems 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 with diabetes (fasting glucose > 126 mg/dL).

-Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, 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 hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.

-Current pregnancy or a history of pregnancy. A negative pregnancy test before starting 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 influence performance on neurocognitive measures (i.e., any history of loss of consciousness greater than or equal to 30 minutes associated with a head injury, any history of memory loss or hospitalization associated with a head injury, or greater than or equal to 2 concussions within last year).

-Presence of any significant, full-threshold psychiatric disorder based on DSM criteria such as schizophrenia, bipolar disorder, alcohol or substance abuse, anorexia or bulimia nervosa, or any disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. These individuals will not be permitted to enroll in the current study and will be referred for treatment. Individuals who present with other psychiatric disorders, including sub-threshold psychiatric disorders, will be permitted to enroll in the study. Sub-threshold psychiatric disorders include symptoms that do not meet diagnostic threshold based on the DSM criteria for mental disorders, but which are nevertheless significantly impairing or distressing. If, based on the opinion of the investigators, a participant requires treatment for his/her psychiatric symptoms,, the individual will be referred for treatment. Participants who develop any psychiatric disorder or significant psychiatric symptoms at any follow-up assessment during the 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 of the investigators, would impede compliance or possibly hinder completion of the study (e.g., significant Learning Disorder).

Additional exclusions for (optional) stool sample collection include:

Stool Sample only:

-Diagnosis or history of inflammatory bowel disease, including ulcerative colitis or Crohn's disease, celiac sprue, irritable bowel syndrome, or other inflammatory 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 endocrine functioning, including alpha and beta blockers, oral contraceptives, or prescription 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 body, braces, glasses required to correct vision, presence of non-organic [e.g., cochlear] implants or cerebral clips, permanent tattooed makeup or general tattoos in a dangerous location on the body or made with colors whose content in iron cannot be definitely ruled out.

-Youth will be excluded if they are left-handed.

All participants will receive a written explanation of the purposes, procedures, and potential hazards of the study. Communication of this information and of the participant s assent as well as the consent of the parent or guardian will be documented in the medical record and copies of all signed documents given to each family. All participants will be informed of their right to withdraw from the study.


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Citations:

Tanofsky-Kraff M, Yanovski SZ, Wilfley DE, Marmarosh C, Morgan CM, Yanovski JA. Eating-disordered behaviors, body fat, and psychopathology in overweight and normal-weight children. J Consult Clin Psychol. 2004 Feb;72(1):53-61. doi: 10.1037/0022-006X.72.1.53. PMID: 14756614; PMCID: PMC2630209.

Tanofsky-Kraff M, Shomaker LB, Olsen C, Roza CA, Wolkoff LE, Columbo KM, Raciti G, Zocca JM, Wilfley DE, Yanovski SZ, Yanovski JA. A prospective study of pediatric loss of control eating and psychological outcomes. J Abnorm Psychol. 2011 Feb;120(1):108-18. doi: 10.1037/a0021406.

Tanofsky-Kraff M, Cohen ML, Yanovski SZ, Cox C, Theim KR, Keil M, Reynolds JC, Yanovski JA. A prospective study of psychological predictors of body fat gain among children at high risk for adult obesity. Pediatrics. 2006 Apr;117(4):1203-9. doi: 10.1542/peds.2005-1329. PMID: 16585316; PMCID: PMC1863068.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jack A. Yanovski, M.D.
National Institute of Child Health and Human Development (NICHD)
BG 10-CRC RM 2-3142
10 CENTER DR
BETHESDA MD 20814
(301) 496-0858
jy15i@nih.gov

Esther A. Kwarteng
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 10
Room 2-3152
10 Center Drive
Bethesda, Maryland 20892
(301) 451-8097
esther.kwarteng@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02390765

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