Osteoporosis Prevention: Changes to Exercise and Diet in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2004-02-29

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Physical activity and nutrition intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Melbourne Hovell

Director of CBEACH, Distinguished Professor of Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melbourne F. Hovell, Ph.D., MPH

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

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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

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

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.