The BONES Project: Building Healthy Bones in Children
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|ClinicalTrials.gov Identifier: NCT00065247|
Recruitment Status : Unknown
Verified June 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Active, not recruiting
First Posted : July 22, 2003
Last Update Posted : June 24, 2005
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|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Behavioral: Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1500 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Beat Osteoporosis: Nourish and Exercise Skeletons (BONES)|
|Study Start Date :||June 1999|
|Study Completion Date :||May 2004|
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||6 Years to 9 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Enrolled in participating after-school program
- Live in Massachusetts or Rhode Island
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065247
|United States, Massachusetts|
|Tufts University Gerald J. and Dorothy R. Friedman School of Nutrition, Science and Policy|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Christina D. Economos, PhD||Tufts University|
|Other Study ID Numbers:||
R01HD037752 ( U.S. NIH Grant/Contract )
|First Posted:||July 22, 2003 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||June 2003|
Bone Diseases, Metabolic