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Osteoporosis Prevention: Changes to Exercise and Diet in Children

San Diego State University logo

San Diego State University

Status and phase

Completed
Phase 2

Conditions

Osteoporosis

Treatments

Behavioral: Physical activity and nutrition intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT00063050
R01HD037749

Details and patient eligibility

About

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.

Full 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.

Enrollment

155 patients

Sex

All

Ages

10 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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