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

NCT ID: NCT01613001

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67904 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-11-30

Brief Summary

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.

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.

Conditions

Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mike O'Callaghan Military Hospital

FED

Sponsor Role: lead

Responsible Party

Paul Crawford

Clinical Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathaniel Nye, MD

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Military Hospital

Other Identifiers

FWH20120036H

Identifier Type: -

Identifier Source: org_study_id