Examining lifestyle factors affecting heart disease and diabetes in veterans with PTSD
Impact of Lifestyle on Cardiovascular and Metabolic Risk Factors in Trauma Exposed Post-9/11 Veterans
This study looks at how things like diet and exercise affect heart disease and diabetes risk in veterans with PTSD to see if changing these habits can help improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04911153 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between lifestyle factors, such as physical activity and diet, and the risk of developing cardiometabolic diseases in post-9/11 veterans, particularly those diagnosed with PTSD. It aims to understand how these modifiable factors influence health outcomes and the mechanisms linking PTSD to increased risks of conditions like heart disease and diabetes. By assessing veterans with and without PTSD, the study seeks to identify effective lifestyle interventions that could improve cardiometabolic health and reduce disability among this population.
Who should consider this trial
Good fit: Ideal candidates for this study are military veterans or active service members aged 18-75 who have deployed in support of post-9/11 operations, particularly those with a diagnosis of PTSD.
Not a fit: Patients with neurological illnesses, cognitive disorders, or current psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to targeted lifestyle interventions that significantly reduce the risk of heart disease and diabetes in veterans with PTSD.
How similar studies have performed: Other studies have shown promising results in understanding the impact of lifestyle interventions on health outcomes in veterans, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * individuals must be age 18-75 * a military veteran or active military service member who has deployed or is scheduled to deploy in support of post-9/11 operations, such as: * Operation Iraqi Freedom * Operations Enduring Freedom * Operation New Dawn * there are no additional inclusion criteria for Aims 1 and 2 * however, for the Supplemental Aim, to be eligible to participate all interested veterans must have a diagnosis of PTSD (i.e., current or lifetime) Exclusion Criteria: * individuals will be excluded for a history of neurological illness or cognitive disorders other than TBI (e.g., Huntington's, Parkinson's, dementia, or Multiple Sclerosis), and non-TBI related seizures * additionally, individuals are excluded for a current diagnosis of psychotic disorders, schizophrenia, bipolar disorders, current suicidal or homicidal ideation/intention/planning * there are no additional exclusionary criteria for Aims 1 and 2 * however, for the Supplemental Aim, any participants with an absolute or relative contraindication to exercise testing as recommended by the American Thoracic Society and the American College of Chest Physicians (e.g., acute myocardial infarction, unstable angina, respiratory failure, uncontrolled asthma, orthopedic impairments that compromise exercise performance, uncontrolled heart failure and acute hypertension) will be excluded from the cardiorespiratory exercise test
Where this trial is running
Boston, Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: James W Whitworth, PhD — VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
- Study coordinator: James W Whitworth, PhD
- Email: James.Whitworth@va.gov
- Phone: (617) 232-9500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.