Children s Growth and Behavior Study

NCT02390765 | Recruiting

• 2 other identifiers: 15009615-CH-0096
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Eating Behaviors; Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Differences in eating behavior of pediatric participants

  Multiple outcome measures

  up to 6 years of follow-up

Secondary Outcomes (8)

• 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 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

• 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

• Experiment 2 (Hormone and Brain Development Study): oscillatory power activity in hypothesized brain regions-of-interest

  During social threat attention bias paradigm

Study Arms (2)

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

Eligibility Criteria

• Age: 8 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• Parents/Guardians will qualify if they meet the following criteria.
• Age \>=18 years
• Have a child enrolled in this protocol (15-CH-0096).

You may not qualify if:

• 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:
• 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).
• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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.

  PMID: 21114355 BACKGROUND

• 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 BACKGROUND

• Parker MN, Tanofsky-Kraff M, Bloomer BF, Te-Vazquez J, Adekola PE, Nwosu EE, Lazareva J, Jones JL, Moore A, Schvey NA, Brady SM, Yang SB, Turner SA, Yanovski JA, Kelly NR. The Effect of Experimentally Induced Cognitive Fatigue on Energy Intake Among Youth With and Without Recent Reported Dietary Restraint. Int J Eat Disord. 2025 Oct;58(10):2003-2008. doi: 10.1002/eat.24508. Epub 2025 Jul 16.

  PMID: 40878932 DERIVED

• Parker MN, Kelly NR, Moore A, Loch LK, Vazquez JT, Bloomer BF, Nwosu EE, Lazareva J, Yang SB, Courville AB, Moursi NA, Brady SM, Olsen CH, Shank LM, Tanofsky-Kraff M, Yanovski JA. Cognitive fatigue did not significantly influence youth's total energy intake or snack food consumption during a randomized trial. J Behav Med. 2025 Aug;48(4):683-693. doi: 10.1007/s10865-025-00577-8. Epub 2025 Jun 9.

  PMID: 40489009 DERIVED

• Smith MR, Bittner JMP, Loch LK, Haynes HE, Bloomer BF, Te-Vazquez J, Bowling AI, Brady SM, Tanofsky-Kraff M, Chen KY, Yanovski JA, Cheon BK. Independent and Interactive Associations of Subjective and Objective Socioeconomic Status With Body Composition and Parent-Reported Hyperphagia Among Children. Child Obes. 2024 Sep;20(6):394-402. doi: 10.1089/chi.2023.0086. Epub 2023 Nov 9.

  PMID: 37943608 DERIVED

• Rubin AG, Schvey NA, Shank LM, Altman DR, Swanson TN, Ramirez E, Moore NA, Jaramillo M, Ramirez S, Davis EK, Broadney MM, LeMay-Russell S, Byrne ME, Parker MK, Brady SM, Kelly NR, Tanofsky-Kraff M, Yanovski JA. Associations between weight-based teasing and disordered eating behaviors among youth. Eat Behav. 2021 Apr;41:101504. doi: 10.1016/j.eatbeh.2021.101504. Epub 2021 Mar 29.

  PMID: 33831812 DERIVED

• Schvey NA, Shank LM, Tanofsky-Kraff M, Ramirez S, Altman DR, Swanson T, Rubin AG, Kelly NR, LeMay-Russell S, Byrne ME, Parker MN, Broadney MM, Brady SM, Yanovski SZ, Yanovski JA. Weight-based teasing in youth: Associations with metabolic and inflammatory markers. Pediatr Obes. 2021 Mar;16(3):e12729. doi: 10.1111/ijpo.12729. Epub 2020 Oct 15.

  PMID: 33059389 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Feeding Behavior; Fractures, Stress; Bulimia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Fractures, Bone; Wounds and Injuries; Hyperphagia; Signs and Symptoms, Digestive

Study Officials

• Bobby K Cheon

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bobby K Cheon

CONTACT

(301) 827-1857; bobby.cheon@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 18, 2015
• Study Start: April 21, 2015
• Primary Completion (Estimated): December 12, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: NIH subject data will become available starting 6 months after publication of a results paper and will be available from the NIH site for 2 years.
• Access Criteria: NIH data with personal identifiers removed will be shared upon reasonable request to the PI, who will review requests. A data sharing agreement will be required to be negotiated with NICHD before sharing takes place.

Locations

US (1)