Background:
Obesity affects 1 in 5 children in the United States. Childhood obesity often persists into adolescence and adulthood. It can also raise the risk of sleep apnea, fatty liver disease, and fluid buildup in the brain and lead to early-onset puberty. This natural history study will explore how factors such as genes, hormones, diet, and chemical exposures affect puberty in children with obesity.
Objective:
To learn which factors predict the early start of puberty in children with obesity vs those of normal weight.
Eligibility:
Children aged 5 to 7 years with obesity or of normal weight.
Design:
Participants will have clinic visits every 6 months until they reach age 12.
Each clinic visit will include these tests and procedures:
A physical exam.
Collection of blood, urine, and saliva samples. Some samples will be used for genetic tests.
Questions about medical history and medications and supplements.
A questionnaire about their physical activity over the previous week.
A silicone wrist band. Participants will wear a soft wristband for a week prior to each visit. It will tell researchers what chemicals the children were exposed to during that time.
Breast ultrasound, for girls. A gel will be applied, and a wand will be pressed against the skin. The wand uses sound waves to see the tissue inside the breast.
DXA whole body scan. Once a year, participants will have a DXA (dual energy X-ray absorptiometry) scan. This scan measures the amount of bone, muscle, and fat in the body.
Optional food diary. Parents may record everything the participant eats for two 24-hour periods
...
Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records
Male or female, aged 5 to 7 years at the screening visit
Normal weight (defined as BMI > 5th percentile and <85th percentile for age and sex) or Obese weight (defined as BMI > 95th percentile for age and sex)
Ability of parent or guardian to understand and willingness to sign a written informed consent document. And ability of the participant (child) to provide verbal assent and/or to sign a written assent document.
Known diagnosis of syndromic/genetic form of obesity
Current use of medications or supplements that affect reproductive hormones (e.g., estrogen, progesterone, testosterone, puberty blockers, regular use of lavender oil or tea tree oil)
Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator
Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator
Children from the community and the Obesity Weight Management Clinic within the greater Raleigh, Durham, Chapell Hill North Carolina area.
Cohort
Prospective
Weight loss intervention
BehavioralPediatric Weight Management Clinic, which utilizes multiple, individualized strategies to effect weight loss (such as nutrition, behavioral therapy, exercise programs)
No Weight loss intervention
BehavioralNo strategies for weight loss
To identify predictors of pubertal timing in 5-12-year-old children with obesity
1\. pubertal markers by questionnaire, physical exam (testicular volume, Tanner breast staging), and 2. ultrasound (breast morphological stage).
To determine the effect of obesity on reproductive hormones and adrenarche.
Tanner pubic hair staging, reproductive hormones
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This trial is not recruiting at the moment. You can still explore other options: