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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00067925 |
The Incorporating More Physical Activity and Calcium in Teens (IMPACT) study was a behaviorally-based middle school nutrition and physical activity program for the prevention of osteoporosis. The goal of IMPACT was to increase calcium intake and physical activity to help build bone mass in girls.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Behavioral: Incorporating More Physical Activity and Calcium in Teens (IMPACT) Program |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Incorporating More Physical Activity and Calcium in Teens (IMPACT): A School-Based Osteoporosis Prevention Program for Adolescent Girls |
Estimated Enrollment: | 718 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | June 2002 |
Peak bone mass is achieved during the first twenty years of life, and dietary and activity patterns that contribute to the formation of peak bone mass are developed during childhood. The IMPACT intervention was designed to increase bone density and ultimately prevent osteoporosis during adulthood.
IMPACT included physical education, food service, and classroom environmental and behavioral components and was delivered by physical education (PE) specialists, food service personnel, and classroom teachers.
A group of 718 sixth grade girls (mean age 11.1) from twelve middle schools in central Texas participated in the study. The group was 72% non-Hispanic white, 12% Hispanic, 5% African American, and 11% other ethnicity. After baseline measurements were completed in the fall of 2000, the twelve middle schools were pair-matched based on school characteristics (ethnicity, % economically disadvantaged, % girls in athletics) to a control (usual health education program) or the IMPACT program. The intervention was implemented for 18 months and consisted of three major components: a PE component, which emphasized daily weight-bearing activities (WBA); a health lessons component consisting of sixteen behaviorally-based lessons which emphasized WBA, calcium-rich foods, and osteoporosis prevention; and a food service component.
Outcome measures included physical properties of the students' heel bones, calcium consumption, physical activity, and psychosocial factors believed to be precursors to these behaviors. Changes at the school environmental level, such as the number of calcium rich foods offered in the cafeteria and the number of opportunities offered for weight-bearing and aerobic activity, were also assessed.
Ages Eligible for Study: | 10 Years to 13 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Study ID Numbers: | R01HD37767 |
Study First Received: | September 3, 2003 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00067925 History of Changes |
Health Authority: | United States: Federal Government |
Weight-bearing physical activity Calcium intake School-based health education |
Adolescent girls Child nutrition Diet |
Body Weight Calcium, Dietary Musculoskeletal Diseases |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |