Osteoporosis Clinical Trial
Official title:
Healthy Children Healthy Families
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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