- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01613001
Obesity as a Risk Factor for Musculoskeletal Diseases in the U.S. Air Force: Associations and Implications for Force Readiness
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
DoD Beneficiaries
Exclusion: Active Duty Air Force members with the following conditions will be excluded from the study:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Obesity vs musculoskeletal disease risk
Time Frame: within 7 years
|
within 7 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nathaniel Nye, MD, Mike O'Callaghan Military Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWH20120036H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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