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Completed

NCT Number: NCT00063050

Osteoporosis Prevention: Changes to Exercise and Diet in Children

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.

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Key information

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity and nutrition intervention

Behavioral

Primary outcomes

  1. DXA - at baseline and 9 months

  2. Nutrient Intake Interview - at baseline, 3, 9 and 12 months

  3. Physical Activity Recall - at baseline, 3, 9 and 12 months

  4. Strength/Fitness measures - at baseline, 3, 9 and 12 months

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Official study title

Healthy Children Healthy Families

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Jun 20, 2003
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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