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Home > "T" Clinical Trials Conditions > The BONES Project: Building Healthy Bones in Children  The BONES Project: Building Healthy Bones in Children
The BONES Project: Building Healthy Bones in Children
For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 6 Years/9 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Enrolled in participating after-school program - Live in Massachusetts or Rhode Island
Total Enrollment: 1500
Location and Contact Information:
Overall Study Official:
ChristinaEconomos, Principal Investigator, Tufts University
Tufts University Gerald J. and Dorothy R. Friedman School of Nutrition, Science and Policy
Boston, Massachusetts, 02111
United States
Additional Information:
Study ID Numbers: R01HD37752;
Study Start Date: June 1999
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065247
Other Osteoporosis Studies:
1. Zometa - Femara Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women with Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
2. Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis
3. Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major
4. Randomized Study of Human Parathyroid Hormone in Middle-Aged Men with Idiopathic Osteoporosis
5. Once Weekly Parathyroid Hormone for Osteoporosis
Related Studies:
Other Osteoporosis Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
The BONES Project: Building Healthy Bones in Children
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