Osteoporosis Prevention: Changes to Exercise and Diet in Children

Osteoporosis Clinical Trial

Official title:

Healthy Children Healthy Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063050
• Other study ID #: R01HD037749
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2003
• Last updated: November 14, 2011
• Start date: April 2000
• Est. completion date: February 2004

Study information

• Verified date: November 2011
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Physical activity and nutrition intervention

Locations

Country	Name	City	State
United States	The Center for Behavioral Epidemiology and Community Health at the Graduate School of Public Health at San Diego State University	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hovell MF, Nichols JF, Irvin VL, Schmitz KE, Rock CL, Hofstetter CR, Keating K, Stark LJ. Parent/Child training to increase preteens' calcium, physical activity, and bone density: a controlled trial. Am J Health Promot. 2009 Nov-Dec;24(2):118-28. doi: 10. — View Citation

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DXA - at baseline and 9 months
Primary	Nutrient Intake Interview - at baseline, 3, 9 and 12 months
Primary	Physical Activity Recall - at baseline, 3, 9 and 12 months
Primary	Strength/Fitness measures - at baseline, 3, 9 and 12 months