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| Tracking Information | |||||
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| First Received Date ICMJE | July 18, 2003 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | June 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00065247 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The BONES Project: Building Healthy Bones in Children | ||||
| Official Title ICMJE | Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) | ||||
| Brief Summary | The Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project is an after-school program that includes weight loading physical activity, nutrition and bone health education, and calcium-rich snacks. The program is designed to improve bone health in early elementary school children. |
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| Detailed Description | Osteoporosis is a serious public health concern expected to threaten 52 million Americans by the year 2010. This debilitating disease comes at an annual cost of $17 billion. By optimizing bone development during the growing years, individuals can lower their risk of osteoporosis by building an adequate reserve of bone. This study will implement and evaluate an after-school program with exercise, education, and diet components designed to improve bone quality and muscle strength in early elementary school children. First and second grade children from 84 after school programs in 33 diverse communities throughout Massachusetts and Rhode Island will be enrolled in the study. After-school programs will be randomized to either the BONES Project, to the BONES Project plus a parent/caregiver component, or to a no-intervention control group. The BONES curriculum will be implemented 4 days per week over a 20- to 25-week period; each after-school program will implement the program for 2 years. Participants will be followed for an additional year, assuming they remain in the after-school program or do not withdraw for some other reason. All parents will be asked to complete a Child Medical History survey and a Parent Health Survey at baseline, during the 2-year intervention, and at the end of the follow-up year. Parents in the BONES Project plus parent/caregiver component will receive a newsletter and worksheet 5 times per year. Participants will be assessed by quantitative ultrasound, height, weight, and body composition measurements, muscular strength, self competence, physical activity level, food knowledge and preference, calcium intake, perceived parental support, and sleep habits. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE | Osteoporosis | ||||
| Intervention ICMJE | Behavioral: Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 1500 | ||||
| Completion Date | May 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
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| Gender | Both | ||||
| Ages | 6 Years to 9 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00065247 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01HD37752 | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | June 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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