Osteoporosis Prevention: Changes to Exercise and Diet in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00063050
Recruitment Status : Completed
First Posted : June 20, 2003
Last Update Posted : November 16, 2011
Information provided by (Responsible Party):
Melbourne Hovell, San Diego State University

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Behavioral: Physical activity and nutrition intervention Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Healthy Children Healthy Families
Study Start Date : April 2000
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00063050

United States, California
The Center for Behavioral Epidemiology and Community Health at the Graduate School of Public Health at San Diego State University
San Diego, California, United States, 92123
Sponsors and Collaborators
San Diego State University
Principal Investigator: Melbourne F. Hovell, Ph.D., MPH San Diego State University

Publications of Results:
Other Publications:
Schmitz KE, Hovell MF, Nichols JF, Irvin VL, Keating K, Simon GM, Gehrman C, Jones KL. Validation study of adolescents' puberty self-assessments. Journal of Early Adolescence 2004; 24(4): 357-384.
Nichols JF, Irvin V, Schmitz KE, Hovell MF. Body Composition and Fat Distribution in Non-Hispanic White and Hispanic Pre-Adolescents. Int J of Body Comp Res 6(1):9-16, 2008.

Responsible Party: Melbourne Hovell, Director of CBEACH, Distinguished Professor of Public Health, San Diego State University Identifier: NCT00063050     History of Changes
Other Study ID Numbers: R01HD037749 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2003    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

Keywords provided by Melbourne Hovell, San Diego State University:
Bone density
Health education
Health promotion
Physical fitness
Parent training
Injury control

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases