Osteoporosis Prevention: Changes to Exercise and Diet in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melbourne Hovell, San Diego State University
ClinicalTrials.gov Identifier:
NCT00063050
First received: June 19, 2003
Last updated: November 14, 2011
Last verified: November 2011
  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 Intervention Phase
Osteoporosis
Behavioral: Physical activity and nutrition intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Healthy Children Healthy Families

Resource links provided by NLM:


Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • DXA - at baseline and 9 months
  • Nutrient Intake Interview - at baseline, 3, 9 and 12 months
  • Physical Activity Recall - at baseline, 3, 9 and 12 months
  • Strength/Fitness measures - at baseline, 3, 9 and 12 months

Enrollment: 155
Study Start Date: April 2000
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063050

Locations
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
Investigators
Principal Investigator: Melbourne F. Hovell, Ph.D., MPH San Diego State University
  More Information

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.

Responsible Party: Melbourne Hovell, Director of CBEACH, Distinguished Professor of Public Health, San Diego State University
ClinicalTrials.gov Identifier: NCT00063050     History of Changes
Other Study ID Numbers: R01HD37749
Study First Received: June 19, 2003
Last Updated: November 14, 2011
Health Authority: United States: Federal Government

Keywords provided by San Diego State University:
Bone density
Children
Adolescents
Behavior
Health education
Health promotion
Physical fitness
Diet
Parent training
Injury control

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

ClinicalTrials.gov processed this record on April 22, 2014