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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:
Information provided by (Responsible Party):
Paul Crawford, Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01613001
First received: June 4, 2012
Last updated: October 15, 2014
Last verified: July 2013
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Obesity vs musculoskeletal disease risk [ Time Frame: within 7 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01613001

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

No publications provided

Responsible Party: Paul Crawford, Clinical Research Coordinator, Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01613001     History of Changes
Other Study ID Numbers: FWH20120036H
Study First Received: June 4, 2012
Last Updated: October 15, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 24, 2014