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Osteoporosis Prevention: Changes to Exercise and Diet in Children - Article


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Osteoporosis

Bone Loss


Clinical Trial: Osteoporosis Prevention: Changes to Exercise and Diet in Children

This study is no longer recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

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 Treatment or Intervention Phase
Osteoporosis
 Behavior: Physical activity and nutrition intervention
Phase II

MedlinePlus related topics:  Osteoporosis

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Healthy Children Healthy Families

Further Study Details: 

Expected Total Enrollment:  150

Study start: April 2000;  Study completion: April 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   -   12 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Location Information


California
      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

Study chairs or principal investigators

Melbourne F. Hovell, Ph.D., MPH,  Principal Investigator,  San Diego State University   

More Information

Study ID Numbers:  R01HD37749
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  June 19, 2003
ClinicalTrials.gov Identifier:  NCT00063050
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: May 11, 2006
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