The BONES Project: Building Healthy Bones in Children | NCT00065247

Studies
The BONES Project: Building Healthy Bones in Children

NCT00065247

Sponsor

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

Status

Unknown status

Last Update Posted

Jun 24, 2005Estimated

Enrollment

1,500

Phase

Not Applicable

Conditions

Osteoporosis

Interventions

Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2003

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1999

Primary Completion Date

Not provided

Completion Date

May 2004

First Submitted Date

Jul 18, 2003

First Submission Date that Met QC Criteria

Jul 21, 2003

First Posted Date

Jul 22, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500

Name	Type	Description	Arm Group Labels	Other Names
Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project	Behavioral

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christina D. Economos, PhD	Tufts University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tufts University Gerald J. and Dorothy R. Friedman School of Nutrition, Science and Policy		Boston	Massachusetts	02111	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32093625	Derived	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.

ID	Term
D010024	Osteoporosis
D009043	Motor Activity

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases