COMPLETED

Lifestyle and Cardiometabolic Risk in Post-9/11 Veterans

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Heart disease and diabetes are leading causes of death and disability in the US, especially among Veterans. Posttraumatic stress disorder (PTSD) is a disabling condition that also affects many Veterans. New research suggests that PTSD further increases the risk of developing heart disease and diabetes. What causes this increased risk is unknown. However, individuals with PTSD are often less physically active and make more unhealthy dietary choices than individuals without PTSD. Maintaining a physically active lifestyle, staying physically fit, and eating a healthy diet may be important for reducing the PTSD related risk for heart disease, diabetes and disability. The proposed research seeks to assess how important these lifestyle factors are for reducing the risk of heart disease, diabetes and disability in Veterans with and without PTSD. A better understanding of these lifestyle factors and cardiometabolic health in Veterans will help to clarify how lifestyle interventions can best be applied to the prevention and treatment of long-term disability in Veterans. Aim 1: To examine physical activity participation as a mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans. This study will longitudinally assess associations between PTSD diagnosis, physical activity, cardiometabolic health, and functioning over time in 250 TRACTS participants. H1-1: Total self-report physical activity will mediate the effects of PTSD on cardiometabolic health and functioning over time, such that lower physical activity will increase the detrimental effect of PTSD on cardiometabolic health and functioning. H1-2: physical activity intensity will moderate the effect physical activity has on cardiometabolic health and functioning. Aim 2: To examine diet quality as a mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans. This study will longitudinally assess associations between PTSD diagnosis, diet quality, cardiometabolic health, and functioning over time in 200 TRACTS participants. H2: Self-report dietary intake will mediate the effects of PTSD on cardiometabolic health and functioning over time, such that a poor diet will increase the detrimental effect of PTSD on cardiometabolic health and functioning. Supplemental Aim: To validate the use of a self-report clinical measure of physical activity against objective measure obtained via accelerometry. Objective measurement of physical activity is not often accessible or feasible for VA providers (e.g., time constraints). It is essential that quick self-report physical activity measures accurately reflect the physical activity of Veterans. This study will compare data from a self-report clinical physical activity measure to objectively measured physical activity/sedentary time (i.e., accelerometry), cardiorespiratory fitness, cardiometabolic health, functioning, and PTSD symptom severity in 100 post-9/11 Veterans. H1A-1: Self-report and objective measurement of physical activity will be significantly correlated. H1A-2: Both self-report and objectively measured physical activity/sedentary time will be associated with cardiorespiratory fitness, cardiometabolic health, functioning, and PTSD symptom severity.

Official Title

Impact of Lifestyle on Cardiovascular and Metabolic Risk Factors in Trauma Exposed Post-9/11 Veterans

Quick Facts

Study Start:2022-02-28
Study Completion:2025-06-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04911153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * individuals must be age 18-75
  2. * 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:
  3. * Operation Iraqi Freedom
  4. * Operations Enduring Freedom
  5. * Operation New Dawn
  6. * there are no additional inclusion criteria for Aims 1 and 2
  7. * however, for the Supplemental Aim, to be eligible to participate all interested veterans must have a diagnosis of PTSD (i.e., current or lifetime)
  1. * 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
  2. * additionally, individuals are excluded for a current diagnosis of psychotic disorders, schizophrenia, bipolar disorders, current suicidal or homicidal ideation/intention/planning
  3. * there are no additional exclusionary criteria for Aims 1 and 2
  4. * 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

Contacts and Locations

Principal Investigator

James W Whitworth, PhD
PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Locations (Sites)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • James W Whitworth, PhD, PRINCIPAL_INVESTIGATOR, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-28
Study Completion Date2025-06-09

Study Record Updates

Study Start Date2022-02-28
Study Completion Date2025-06-09

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • Physical activity
  • Diet
  • Cardiovascular disease
  • Metabolic syndrome
  • Veterans

Additional Relevant MeSH Terms

  • PTSD
  • Cardiovascular Disease
  • Metabolic Syndrome