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| Tracking Information | |||||
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| First Received Date ICMJE | June 19, 2003 | ||||
| Last Updated Date | June 28, 2007 | ||||
| Start Date ICMJE | April 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00063050 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Osteoporosis Prevention: Changes to Exercise and Diet in Children | ||||
| Official Title ICMJE | Healthy Children Healthy Families | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Osteoporosis | ||||
| Intervention ICMJE | Behavioral: Physical activity and nutrition intervention | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 150 | ||||
| Completion Date | February 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 10 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00063050 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01HD37749 | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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