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The BONES Project: Building Healthy Bones in Children - Article


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Osteoporosis

Bone Loss


Clinical Trial: The BONES Project: Building Healthy Bones in Children

This study is no longer recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

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.

Condition Treatment or Intervention
Osteoporosis
 Behavior: Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project

MedlinePlus related topics:  Osteoporosis

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study

Official Title: Beat Osteoporosis: Nourish and Exercise Skeletons (BONES)

Further Study Details: 

Expected Total Enrollment:  1500

Study start: June 1999;  Study completion: May 2004

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

Ages Eligible for Study:  6 Years   -   9 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria

  • Enrolled in participating after-school program
  • Live in Massachusetts or Rhode Island

Location Information


Massachusetts
      Tufts University Gerald J. and Dorothy R. Friedman School of Nutrition, Science and Policy, Boston,  Massachusetts,  02111,  United States

Study chairs or principal investigators

Christina D. Economos, PhD,  Principal Investigator,  Tufts University   

More Information

Study ID Numbers:  R01HD37752
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  July 18, 2003
ClinicalTrials.gov Identifier:  NCT00065247
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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Page Updated: May 11, 2006
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