Osteoporosis Prevention: Changes to Exercise and Diet in Children
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Physical activity and nutrition intervention
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Bone density, Children, Adolescents, Behavior, Health education, Health promotion, Physical fitness, Diet, Parent training, Injury control
Eligibility 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
Sites / Locations
- The Center for Behavioral Epidemiology and Community Health at the Graduate School of Public Health at San Diego State University
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00063050
First Posted
June 19, 2003
Last Updated
November 14, 2011
Sponsor
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT00063050
Brief Title
Osteoporosis Prevention: Changes to Exercise and Diet in Children
Official Title
Healthy Children Healthy Families
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Bone density, Children, Adolescents, Behavior, Health education, Health promotion, Physical fitness, Diet, Parent training, Injury control
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Physical activity and nutrition intervention
Primary Outcome Measure Information:
Title
DXA - at baseline and 9 months
Title
Nutrient Intake Interview - at baseline, 3, 9 and 12 months
Title
Physical Activity Recall - at baseline, 3, 9 and 12 months
Title
Strength/Fitness measures - at baseline, 3, 9 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melbourne F. Hovell, Ph.D., MPH
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Behavioral Epidemiology and Community Health at the Graduate School of Public Health at San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
19928484
Citation
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: 10.4278/ajhp.08021111.
Results Reference
result
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Osteoporosis Prevention: Changes to Exercise and Diet in Children
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