RECRUITING

Investigating the Impact of Obesity on Pubertal Development in Girls

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Studies suggest that overweight girls may be developing breast tissue, and therefore starting puberty, earlier than normal weight girls. However, it is hard to distinguish breast tissue from fatty tissue. Researchers think that by using breast ultrasound, among other tests, they can do a better job of telling whether an overweight girl has breast tissue. This will help them understand if overweight girls are truly entering puberty before normal weight girls. Objective: To find out if overweight girls go through puberty earlier than normal weight girls. Eligibility: Healthy girls 8-14 years old who: * Are normal weight or overweight * Have some breast development * Have not started their first period Design: Parents of participants will be screened over the phone. Most participants will have 1 visit. However, they can choose to have multiple visits within 4 weeks. The visit will include: * Physical exam that includes examination of the breasts and genital area * Breast ultrasound: A small hand-held device will be passed back and forth over the chest. It uses sound waves to create a picture of the breast tissue. * Pelvic ultrasound: A small, handheld device will be passed back and forth over the lower belly. It uses sound waves to create a picture of the ovaries. * Urine and blood test * A special x-ray called a DXA to measure the amount of fat in the body: The participant will lie still on a table while the x-ray takes pictures of the body. X-ray of the hand: The picture will tell researchers how mature the participant s bones are. Participants may be asked to come back 6 months later to repeat these tests. ...

Official Title

Investigating the Impact of Obesity on Pubertal Development in Girls

Quick Facts

Study Start:2015-12-15
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02583646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 14 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Girls without a chronic medical condition
  2. * Normal weight (BMI 5th-85th%) or overweight/obese (BMI \> 85th%)
  3. * 8-14 years old
  4. * Some breast development
  5. * Pre-menarchal
  1. * Treated with medications that may affect reproductive hormones (e.g. birth control pills).
  2. * Pregnancy

Contacts and Locations

Study Contact

NIEHS Join A Study Recruitment Group
CONTACT
(855) 696-4347
myniehs@nih.gov
Natalie D Shaw, M.D.
CONTACT
(984) 287-3716
natalie.shaw@nih.gov

Principal Investigator

Natalie D Shaw, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Environmental Health Sciences (NIEHS)

Study Locations (Sites)

NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
United States

Collaborators and Investigators

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

  • Natalie D Shaw, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Environmental Health Sciences (NIEHS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-12-15
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2015-12-15
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Obesity
  • Puberty
  • Ultrasound
  • Pediatric
  • Natural History

Additional Relevant MeSH Terms

  • Obesity
  • Puberty
  • Normal Physiology