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| Sponsor: | San Diego State University |
|---|---|
| Information provided by (Responsible Party): | Melbourne Hovell, San Diego State University |
| ClinicalTrials.gov Identifier: | NCT00063050 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Behavioral: Physical activity and nutrition intervention |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Healthy Children Healthy Families |
| Enrollment: | 155 |
| Study Start Date: | April 2000 |
| Study Completion Date: | February 2004 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 10 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, California | |
| 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, 92123 | |
| Principal Investigator: | Melbourne F. Hovell, Ph.D., MPH | San Diego State University |
More Information
| Responsible Party: | Melbourne Hovell, Director of CBEACH, Distinguished Professor of Public Health, San Diego State University |
| ClinicalTrials.gov Identifier: | NCT00063050 History of Changes |
| Other Study ID Numbers: | R01HD37749 |
| Study First Received: | June 19, 2003 |
| Last Updated: | November 14, 2011 |
| Health Authority: | United States: Federal Government |
|
Bone density Children Adolescents Behavior Health education |
Health promotion Physical fitness Diet Parent training Injury control |
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |