ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Osteoporosis Prevention: Changes to Exercise and Diet in Children

This study is ongoing, but not recruiting participants.

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00063050
  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 II

MedlinePlus related topics:   Exercise and Physical Fitness    Osteoporosis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Healthy Children Healthy Families

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Estimated Enrollment:   150
Study Start Date:   April 2000
Estimated Study Completion Date:   February 2004

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

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.
 

Study ID Numbers:   R01HD37749
First Received:   June 19, 2003
Last Updated:   June 28, 2007
ClinicalTrials.gov Identifier:   NCT00063050
Health Authority:   United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Bone density  
Children  
Adolescents  
Behavior  
Health education  
Health promotion
Physical fitness
Diet
Parent training
Injury control

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Healthy
Bone Diseases

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers