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Obesity as a Risk Factor for Musculoskeletal Diseases in the U.S. Air Force: Associations and Implications for Force Readiness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01613001
First Posted: June 6, 2012
Last Update Posted: October 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul Crawford, Mike O'Callaghan Federal Hospital
  Purpose
To study the first hypothesis, a retrospective cohort analysis of Air Force members from January 2005 to December 2010 will be performed to evaluate the association of obesity as an independent predictor variable with musculoskeletal disease as the dependent variable.

Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Further study details as provided by Paul Crawford, Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • Obesity vs musculoskeletal disease risk [ Time Frame: within 7 years ]

Enrollment: 67904
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
DoD Beneficiaries

Exclusion: Active Duty Air Force members with the following conditions will be excluded from the study:

  • Documented preexisting musculoskeletal injury/disease before onset of obesity
  • Hypothyroidism/Hyperthyroidism
  • Hyperparathyroidism
  • Osteopenia/Osteoporosis
  • Nicotine dependence
  • Alcohol dependence
  • Eating disorders (anorexia nervosa, bulimia nervosa)
  • Cancer requiring chemotherapy or radiation therapy
  • Status-post gastrectomy
  • Status-post bilateral oophorectomy
  • Crohn's Disease
  • Ulcerative Colitis
  • Celiac Disease
  • Cushing's Disease
  • Prior to or during the study period, more than 6 months of taking proton pump inhibitors, medroxyprogesterone acetate, bisphosphonates, methotrexate, selective serotonin reuptake inhibitors, or inhaled/intranasal corticosteroids
  • Prior to or during the study period, more than 1 month of taking fluoroquinolones, oral or intramuscular corticosteroids, oral or intramuscular testosterone, or leuprolide

Detailed Description:

To study the first hypothesis, a retrospective cohort analysis of Air Force members from January 2005 to December 2010 will be performed to evaluate the association of obesity as an independent predictor variable with musculoskeletal disease as the dependent variable. A second analysis will be performed on the same cohort using musculoskeletal disease as an independent predictor variable, as well as evaluating a potential interaction between obesity and musculoskeletal disease, to determine the association of these variables with the dependent variable of service member readiness for duty. The independent variables for the analyses include:

  • Age
  • Sex
  • BMI
  • Fitness data (PIMR: PFT scores, weight, height, BMI, abdominal circumference)
  • Profile data (PIMR: Number of profiles, number of profiles due to musculoskeletal diagnoses, total days on duty limitation, total days on mobility limitation)
  • Total number of deployments served
  • All new musculoskeletal diagnoses (see attached abbreviated ICD-9 list)
  • Incidence of member separation from AF
  • Incidence of disability retirement
  • X-rays
  • Surgeries (orthopaedic, general)
  • Referrals to the Orthopaedic Department
  • Referrals to the Pain Clinic
  • New diagnosis of diabetes mellitus
  • Death

All data will be gathered by SG6H, Healthcare Informatics Division, and de-identified. Then the de-identified data will be coded and sent to the Principal Investigator for analysis. All informational data sets will be totally de-identified prior to releasing to the Principle Investigator to be analyzed by a statistician.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
DoD Beneficiaries
Criteria

Exclusion: Active Duty Air Force members with the following conditions will be excluded from the study:

  • Documented preexisting musculoskeletal injury/disease before onset of obesity
  • Hypothyroidism/Hyperthyroidism
  • Hyperparathyroidism
  • Osteopenia/Osteoporosis
  • Nicotine dependence
  • Alcohol dependence
  • Eating disorders (anorexia nervosa, bulimia nervosa)
  • Cancer requiring chemotherapy or radiation therapy
  • Status-post gastrectomy
  • Status-post bilateral oophorectomy
  • Crohn's Disease
  • Ulcerative Colitis
  • Celiac Disease
  • Cushing's Disease
  • Prior to or during the study period, more than 6 months of taking proton pump inhibitors, medroxyprogesterone acetate, bisphosphonates, methotrexate, selective serotonin reuptake inhibitors, or inhaled/intranasal corticosteroids
  • Prior to or during the study period, more than 1 month of taking fluoroquinolones, oral or intramuscular corticosteroids, oral or intramuscular testosterone, or leuprolide
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613001


Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
Principal Investigator: Nathaniel Nye, MD Mike O'Callaghan Military Hospital
  More Information

Responsible Party: Paul Crawford, Clinical Research Coordinator, Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01613001     History of Changes
Other Study ID Numbers: FWH20120036H
First Submitted: June 4, 2012
First Posted: June 6, 2012
Last Update Posted: October 16, 2014
Last Verified: July 2013

Additional relevant MeSH terms:
Obesity
Musculoskeletal Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms