Osteoporosis Prevention: Changes to Exercise and Diet in Children

Phase 2

Completed

• Conditions: Osteoporosis

• Registration Number: NCT00063050
• Lead Sponsor: San Diego State University

Brief Summary

The purpose of this study is to determine whether educating parents about health and behavior management techniques will increase physical activity, calcium intake, fitness, and bone density in their children.

Detailed Description

In recent years, osteoporosis has become a major public health problem in the United States. Osteoporosis can best be prevented by optimizing bone mineral gain and reducing bone loss. Because the rate of bone development reaches its peak during adolescence, fostering bone health in childhood is of critical importance. Although there have been many studies of exercise and nutritional factors that influence bone mass in adults, few randomized, prospective studies have been conducted in children. This study will determine whether parent training is effective in increasing children's calcium intake, strength, and frequency of aerobic exercise.

Families will be randomly assigned to either the physical activity and nutrition intervention group or to the injury prevention control group. Families in both groups will undergo training during 9 weekly classes. The intervention training will emphasize health topics, principles of behavior, and contingency management techniques. Post-training coaching procedures will be provided periodically for 9 months. Coaching procedures will assist parents with problem solving and help them refine and maintain parenting skills. All families will be assessed prior to training and at Months 3, 9, and 12. Outcome measures will include 24-hour recall estimates of change in diet and change in physical activity. Total bone calcium, bone density, body composition, and skeletal age will also be assessed.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2003-06-19
• Study First Submitted QC: 2003-06-19
• Study First Posted: 2003-06-20
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-14
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DXA - at baseline and 9 months
Nutrient Intake Interview - at baseline, 3, 9 and 12 months
Physical Activity Recall - at baseline, 3, 9 and 12 months
Strength/Fitness measures - at baseline, 3, 9 and 12 months

Trial Locations

Locations (1)

The Center for Behavioral Epidemiology and Community Health at the Graduate School of Public Health at San Diego State University; 🇺🇸 San Diego, California, United States