NCT01613001

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67,904

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 16, 2014

Status Verified

July 1, 2013

Enrollment Period

1.7 years

First QC Date

June 4, 2012

Last Update Submit

October 15, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Obesity vs musculoskeletal disease risk

    within 7 years

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

DoD Beneficiaries

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nathaniel Nye, MD

    Mike O'Callaghan Military Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Coordinator

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

October 16, 2014

Record last verified: 2013-07