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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| 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 |
| MedlinePlus related topics: | Exercise and Physical Fitness Osteoporosis |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Healthy Children Healthy Families |
| Estimated Enrollment: | 150 |
| Study Start Date: | April 2000 |
| Estimated Study Completion Date: | February 2004 |
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
|
Schmitz KE, Hovell MF, Nichols JF, Irvin VL, Keating K, Simon GM, Gehrman C, Jones KL. Validation study of adolescents’ puberty self-assessments. Journal of Early Adolescence 2004; 24(4): 357-384.
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| Study ID Numbers: | R01HD37749 |
| First Received: | June 19, 2003 |
| Last Updated: | June 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00063050 |
| Health Authority: | United States: Federal Government |
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