- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00609713
Bone Health of Obese Adolescents During Weight Loss
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Comprehensive 12-month family-based obesity treatment with separate adolescents and parents group sessions
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Participants will meet weekly for 12 weeks, then every other week for 12 weeks, and once a month thereafter through week 52.
Adolescents and parents will receive manuals that provide lessons and homework assignments for each meeting.
The program for the first 22 weeks includes the following topics: 1) the causes of obesity; 2) components of healthy nutrition; 3) self-monitoring of calories, physical activity, and inactivity; 4) stimulus control procedures; 5) coping with high-risk social or psychological situations that trigger excess eating; 6) increasing physical activity; and 7) minimizing inactivity.
At each session, participants will submit their self-monitoring diaries and completed homework.
Incentives for completion of self-monitoring tasks are an integral part of the behavior modification program and a small gift certificate will be given to subjects for successful completion at each intervention session.
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Active Comparator: 2
Individual 12-month nutrition education program
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The other half of the participants (44 subjects) will be randomized to this arm of the intervention (usual care), which will also start in five waves.
In contrast to the comprehensive behavioral weight control program, the nutrition education program will take place through individual appointments with a clinical dietician to reflect usual care and mimic the present approach used for the treatment of obese adolescents at the Children's Hospital of Philadelphia (CHOP) Nutrition Consultation.
Parents will be required to take part in the consultations.
The first consultation will last 60 minutes and the following consultations of 30 minutes will take place once a month for the first six months, then every other month for the second six months, as is the usual practice in our clinical setting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quantitative computerized tomography (pQCT)
Time Frame: Base line, 6 months, 12 months
|
Base line, 6 months, 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Babette Zemel, PhD, CHOP
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-10-4976
- 1R01HD049701-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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