ObesityNCT01613001
Obesity as a Risk Factor for Musculoskeletal Diseases in the U.S. Air Force: Associations and Implications for Force Readiness
An observational study of Obesity, run by Mike O'Callaghan Military Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 67,904 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
About this study
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.
Read the 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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity vs musculoskeletal disease risk
Measured: within 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 67,904 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Crawford, Mike O'Callaghan Military Hospital
- Investigators
- Nathaniel Nye, MD, Principal investigator, Mike O'Callaghan Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613001
- Sponsor's protocol ID
- FWH20120036H
- Status last verified
- Jul 2013
- First submitted
- 4 Jun 2012
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity as a Risk Factor for Musculoskeletal Diseases in the U.S. Air Force: Associations and Implications for Force Readiness
- ClinicalTrials.gov ID
- NCT01613001
- Acronym / sponsor ID
- FWH20120036H
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67,904 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- DoD Beneficiaries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obesity vs musculoskeletal disease risk
Time frame: within 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Nye, MD principal investigator
Mike O'Callaghan Military Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Mike O'Callaghan Military Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity vs musculoskeletal disease risk (time frame: within 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.