NCT00065247.

Trial name or title	Study name: Beat Osteoporosis: Nourish and Exercise Skeletons (BONES) Project
Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: "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” (quote) Study period: study start date: June 1999, study completion date: May 2004 Total number of arms: 3 Description of intervention arms: 1. The BONES Project plus a parent/caregiver component (child + caregiver); 2. The BONES Project (child only); 3. No intervention control (not eligible) Number of clusters per arm: not known Average cluster size: not known Sample size justification and outcome used: not known Unit of allocation: after‐school program Missing data handling: not known Reported limitations: not reported Randomization ratio and stratification: not known Participant compensation or incentives: not known
Participants	Baseline characteristics: not known Recruitment methods: not known Inclusion criteria: clusters: after‐school programs in Massachusetts and Rhode Island, USA; participants: child aged 6 to 9 years, enrolled in a participating after‐school program, and living in Massachusetts or Rhode Island, USA Exclusion criteria: clusters: not known; participants: not known Age of participating children at baseline: 6 to 9 years Total number randomized by relevant group: 1500 children anticipated Baseline imbalances between relevant groups: not known Total number analyzed by relevant group: not known Attrition by relevant group: not known Description of sample for baseline characteristics reported above: not relevant
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): BONES Project plus a parent/caregiver component Focus of intervention: diet and physical activity Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): not known How, where, and when and how much (TIDieR #6 to 8): caregivers will receive a newsletter and worksheet 5 times per year Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: not known, although it appears that a baseline assessment and 2 subsequent assessments will take place Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): not known Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known Child‐only arm (control group) Brief name/description (TIDieR #1): BONES Project Focus of intervention: diet and physical activity Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): osteoporosis is a serious public health concern. Risk of osteoporosis can be reduced by building an adequate bone reserve by optimizing bone development during childhood How, where, and when and how much (TIDieR #6 to 8): each year for 2 years, the curriculum will be implemented 4 days per week over a 20 to 25‐week period Who: providers (TIDieR #5): not known Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: not known, although it appears that a baseline assessment and 2 subsequent assessments will take place Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): not known Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known Sensitivity analyses: not known
Outcomes	The following relevant outcomes relevant to this review were measured at assessments (time points not specified) Children's physical activity levels (instrument not specified) Children's anthropometry: measured height and weight (instruments not specified)
Starting date	The study began in June 1999, and the trial was registered on July 22, 2003
Contact information	Author's name: Christina Economos Email: christina.economos@tufts.edu Country: USA Setting: after‐school programs in Massachusetts and Rhode Island Types of reports: trial registration Comments: used the following report: (1) trial registration (Clinicaltrials.gov registration number NCT00065247) Conflicts of interest: not known Sponsorship source: National Institute of Child Health and Human Development (R01HD037752)
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