The BONES Project: Building Healthy Bones in Children
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Bone, Children, After-school program, Osteoporosis, Calcium, Physical activity
Eligibility Criteria
Inclusion Criteria Enrolled in participating after-school program Live in Massachusetts or Rhode Island
Sites / Locations
- Tufts University Gerald J. and Dorothy R. Friedman School of Nutrition, Science and Policy
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00065247
First Posted
July 18, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00065247
Brief Title
The BONES Project: Building Healthy Bones in Children
Official Title
Beat Osteoporosis: Nourish and Exercise Skeletons (BONES)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2003
Overall Recruitment Status
Unknown status
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Bone, Children, After-school program, Osteoporosis, Calcium, Physical activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Enrolled in participating after-school program
Live in Massachusetts or Rhode Island
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina D. Economos, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University Gerald J. and Dorothy R. Friedman School of Nutrition, Science and Policy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32093625
Citation
Economos CD, Hennessy E, Chui K, Dwyer J, Marcotte L, Must A, Naumova EN, Goldberg J. Beat osteoporosis - nourish and exercise skeletons (BONES): a group randomized controlled trial in children. BMC Pediatr. 2020 Feb 21;20(1):83. doi: 10.1186/s12887-020-1964-y.
Results Reference
derived
Learn more about this trial
The BONES Project: Building Healthy Bones in Children
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