The BONES Project: Building Healthy Bones in Children

Osteoporosis Clinical Trial

Official title:

Beat Osteoporosis: Nourish and Exercise Skeletons (BONES)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00065247
• Other study ID #: R01HD037752
• Status: Active, not recruiting
• Phase: N/A
• First received: July 18, 2003
• Last updated: June 23, 2005
• Start date: June 1999
• Est. completion date: May 2004

Study information

• Verified date: June 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: May 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria

• Enrolled in participating after-school program

• Live in Massachusetts or Rhode Island

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project

Locations

Country	Name	City	State
United States	Tufts University Gerald J. and Dorothy R. Friedman School of Nutrition, Science and Policy	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States,