Trial record 1 of 1 for:    NCT 00729378
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Jump-In - Building Better Bones

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00729378
First received: August 5, 2008
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

The Jump-In study will prospectively assess the effects of impact exercise on skeletal development in young girls, including bone mass, bone mineral density, and bone geometry. We hypothesize that girls who regularly participate in impact loading exercise will accrue greater skeletal mass, increase bone density and undergo structural adaptations that in combination will improve bone strength compared to girls who do not participate in impact exercise.


Condition Intervention
Skeletal Development
Other: skeletal loading

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Exercise and Bone Development in Young Girls

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bone density, geometry and strength from peripheral quantitative computed tomography (pQCT). [ Time Frame: Baseline, 6 months, one year; yearly thereafter for 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity, soft tissue composition [ Time Frame: Baseline, 6 months, one year, yearly thereafter for 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2007
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: skeletal loading
impact activities, 3 times per week, increasing (up to 40) of jumps and height (from 6 inches to 18 inches per repetition) over the initial 2 months. New activities will be introduced approximately every 2-3 months and continually stress the skeleton over 2 years.
No Intervention: 2 Other: skeletal loading
impact activities, 3 times per week, increasing (up to 40) of jumps and height (from 6 inches to 18 inches per repetition) over the initial 2 months. New activities will be introduced approximately every 2-3 months and continually stress the skeleton over 2 years.

Detailed Description:

Jump-In is a school-based, block-randomized, trial of the effects of impact-loading exercise on skeletal development in prepubescent and early pubescent girls. Fourth (n=~200) and sixth (n=~200) grade girls in 14 Tucson (Arizona) schools with no contraindication to physical exercise will be enrolled. Girls in intervention schools will participate in impact activities 3 times per week at school, progressively increasing the number (up to 40) of jumps and their height (from 6 inches to 18 inches per repetition) over the initial 2 months. Thereafter, new activities will be introduced approximately every 2-3 months to maintain interest and motivation, and continually stress the skeleton in novel ways, over 2 years of intervention. Physical and behavioral assessments will be done in both intervention and control groups at baseline, end of the initial school year, and yearly thereafter for 5 years. Assessments include height and weight, selected skeletal lengths, fat, lean soft tissue, bone mineral content and areal density from dual energy x-ray absorptiometry (DXA), and bone geometry (e.g., cortical thickness, periosteal circumference and cortical and trabecular density) and muscle area from peripheral quantitative computed tomography (pQCT). Also, maturation will be assessed via the Tanner Stage (self-assessment against standardized drawings of stages of physical development), diet from the Harvard Youth Food Frequency Questionnaire, and physical activity using pedometers and standardized questionnaires. We hypothesize that girls in intervention schools will demonstrate enhanced skeletal development, including greater mineral mass and density, and enhanced bone geometry, leading to greater bone strength compared to girls in control schools. We further hypothesize that younger (Tanner State 1) girls will experience greater adaptations than older girls (Tanner 2 and 3), and that positive adaptations will be maintained throughout the 3-year follow-up period.

  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

female; entering 4th or 6th grade at enrollment; and willing and able to undergo all of the testing requirements; no physical activity limitations; able to read and write English.

Exclusion Criteria:

Girls with severe learning disabilities (identified by schools), who are unable to complete questionnaires or otherwise comply with assessment protocols will be excluded. Any subjects (or potential subjects) suffering from medical conditions and/or disabilities that would limit their participation in exercise will be excluded from the study, following the American Academy of Pediatrics (AAP) guidelines. Further, any volunteers who are taking medications that would limit exercise and/or alter bone mineral accrual will also be excluded from the study. Girls with a positive pregnancy screening test at the time of the lab visit before DXA scanning will be excluded.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729378

Contacts
Contact: Michele Graves 520-626-2639 mgraves@u.arizona.edu

Locations
United States, Arizona
University of Arizona-Ina Gittings Bldg. #93 Recruiting
Tucson, Arizona, United States, 85721
Contact: Rob Blew, M.S.    520-626-3067    rblew@u.arizona.edu   
Sponsors and Collaborators
Investigators
Principal Investigator: Scott Going, Ph.D. University of Arizona-Dept. of Nutritional Sciences
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00729378     History of Changes
Other Study ID Numbers: HD050775
Study First Received: August 5, 2008
Last Updated: February 24, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 22, 2014