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Clinical Trials/NCT00063050
NCT00063050
Completed
Phase 2

Healthy Children Healthy Families

San Diego State University1 site in 1 country155 target enrollmentApril 2000
ConditionsOsteoporosis

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
San Diego State University
Enrollment
155
Locations
1
Primary Endpoint
DXA - at baseline and 9 months
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2000
End Date
February 2004
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Melbourne Hovell

Director of CBEACH, Distinguished Professor of Public Health

San Diego State University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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