Bone Health of Obese Adolescents During Weight Loss
Completed · Not applicable
Conditions studied: Pediatric Obesity
In brief
The long-term goal of this proposal is to understand the impact of obesity and obesity treatment on bone health during adolescence and how to preserve it. The recent pediatric obesity epidemic raises important clinical and public health questions about the effects of childhood-onset obesity and its treatment on bone health. Osteoporotic fractures are a major cause of morbidity and mortality in the aged, and peak bone mass (PBM), achieved shortly after puberty, is a key determinant of bone strength and lifetime fracture risk. Given the current obesity epidemic, obesity treatment during adolescence will continue to be necessary. The benefits of pediatric obesity treatment are unquestionable. However, the potential detrimental effects of weight loss on bone density and dimensions are not known in adolescents and are the focus of this proposal. This study will focus on the impact of pediatric-onset obesity and its treatment on bone health, using two approaches: comparing obese and non-obese adolescents and comparing obese adolescents before and after weight loss. We hypothesize that (a) compared to non-obese controls, obese adolescents have stronger bones, and that (b) bone strength of obese adolescents decreases during weight loss compared to usual care, which would suggest a need to promote bone health during successful weight loss in obese adolescents.
Key facts
- Study ID
- NCT00609713
- Run by
- Children's Hospital of Philadelphia
- People needed
- 91
- Starts
- 2007-01-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2013-02-18
Who can join
Age: 10 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eligible participants will be 10.0 to 14.9 years of age, with a body mass index (BMI) above the 97th percentile for age (\~ +1.88 SD) and below +3.00 SD or less than 300 lb (\~ 136 kg), whichever is lower.
You may not qualify if…
- Syndromic or secondary obesity,
- Developmental delay requiring special education,
- Depression, psychosis,
- Eating disorders that involve insufficient or excessive food intake, such as anorexia nervosa or bulimia,
- Orthopedic problems interfering with moderate to vigorous physical activity,
- Diabetes,
- Polycystic ovary syndrome,
- History of systemic corticosteroids use for more than three months cumulatively, use of immunomodulators, anticonvulsivants, weight loss medications (including diet supplements) and any other medications, or chronic conditions that could interfere with the intervention or with bone health.
- Weight loss in the preceding six months of 5% or more, participation in another weight loss program,
- Cigarette smoking (smoking and smoking cessation can affect weight and bones),
- Sexual activity without contraception and/or pregnancy,
- Subjects without a primary care provider or with a provider unwilling to provide to the research team medical information on the child will be excluded.
Where it is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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