The BONES Project: Building Healthy Bones in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2004-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Bone Children After-school program Osteoporosis Calcium Physical activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christina D. Economos, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tufts University Gerald J. and Dorothy R. Friedman School of Nutrition, Science and Policy

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 32093625 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HD037752

Identifier Type: NIH

Identifier Source: org_study_id

View Link