Status:
COMPLETED
Bone Health of Obese Adolescents During Weight Loss
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pediatric Obesity
Eligibility:
All Genders
10-14 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Context: The childhood obesity epidemic raises important clinical and public health questions about the effects of both obesity and obesity treatment on bone development. Osteoporotic fractures are a ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00609713
Start Date
January 1 2007
End Date
May 1 2012
Last Update
February 18 2013
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104