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Osteoporosis Prevention: Changes to Exercise and Diet in Children
This study is ongoing, but not recruiting participants.
Study NCT00063050   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: June 19, 2003   Last Updated: June 28, 2007   History of Changes

June 19, 2003
June 28, 2007
April 2000
 
  • DXA - at baseline and 9 months
  • Nutrient Intake Interview - at baseline, 3, 9 and 12 months
  • Physical Actvity Recall - at baseline, 3, 9 and 12 months
  • Strength/Fitness measures - at baseline, 3, 9 and 12 months
Same as current
Complete list of historical versions of study NCT00063050 on ClinicalTrials.gov Archive Site
 
 
 
Osteoporosis Prevention: Changes to Exercise and Diet in Children
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.

Phase II
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Osteoporosis
Behavioral: Physical activity and nutrition intervention
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
150
February 2004
 

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
Both
10 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00063050
 
R01HD37749
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Melbourne F. Hovell, Ph.D., MPH San Diego State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP