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Home > "O" Clinical Trials Conditions > Osteoporosis Prevention: Changes to Exercise and Diet in Children  Osteoporosis Prevention: Changes to Exercise and Diet in Children
Osteoporosis Prevention: Changes to Exercise and Diet in Children
For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 10 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Participates in organized sports less than 3 days a week and less than 9 months per year - Parent willing to attend weekly training sessions Exclusion Criteria - Serious medical illness - Spends less than 4 days a week with the parent willing to attend classes - Body mass index > 32
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
MelbourneHovell, Principal Investigator, San Diego State University
The Center for Behavioral Epidemiology and Community Health at the Graduate School of Public Health at San Diego State University
San Diego, California, 92123
United States
Additional Information:
Study ID Numbers: R01HD37749;
Study Start Date: April 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063050
Other Osteoporosis Studies:
1. Encouraging Calcium Absorption and Bone Formation During Early Puberty
2. Study of Low Bone Mass in Premenopausal or Perimenopausal Women
3. Efficacy and safety study of intravenous ibandronate to treat postmenopausal osteoporosis as compared to daily oral ibandronate
4. Dietary Phytoestrogens and Bone Metabolism
5. Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis
Related Studies:
Other Osteoporosis Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Osteoporosis Prevention: Changes to Exercise and Diet in Children
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