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临床试验/NCT04911153
NCT04911153已完成不适用

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

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2022年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
230
试验地点
1
主要终点
Aim 1: Total Physical Activity (self-report)

研究概览

简要总结

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.

详细描述

Cardiometabolic disease (e.g., type 2 diabetes or cardiovascular disease) is a leading cause of disability and mortality in the United States, and especially so among Veterans. Posttraumatic stress disorder (PTSD) - a salient health concern for many Veterans and their families - is linked to an increased risk of cardiometabolic disease and premature mortality. The precise mechanisms of this relationship are not fully understood. However, recent research suggests that a diagnosis of PTSD increases the risk for hypertension, dyslipidemia and obesity, all of which are known predictors of cardiometabolic disease. A better understanding of what modifiable factors (e.g., lifestyle) influence the link between PTSD and cardiometabolic health and functioning will aid in the development of novel rehabilitative nonpharmacological interventions (e.g., exercise) for cardiometabolic disease and disability in Veterans with PTSD. Physical activity and diet are promising examples of modifiable lifestyle factors. For instance, regular physical activity and a healthy diet strongly reduce the risk for cardiometabolic disease through numerous pathways, such as reductions in blood pressure, blood lipids, adiposity, and by promoting blood glucose control. Simply put, 80% of all new cases of type 2 diabetes are attributed to physical inactivity and poor diet. Low cardiorespiratory fitness is also a critical factor in the risk for disability and mortality due to cardiovascular disease. Despite the clear value and potential impact, there is little research examining relationships between physical activity and diet, cardiometabolic health, and functioning in Veterans with PTSD. This is a critical research gap. Physical inactivity and poor diet increase the risk of cardiometabolic disease and PTSD likely compounds this risk. Veterans with PTSD often lead sedentary lives and make unhealthy dietary choices placing them in a perfect storm for developing cardiometabolic disease and related disability. The purpose of this project is to examine the influence of several modifiable yet understudied lifestyle factors (i.e., physical activity and diet quality) on indicators of cardiometabolic health, and functioning in post-9/11 Veterans. The aims of this project are:

Aim 1 will examine physical activity participation as a potential mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans from the TRACTS longitudinal cohort study. This study uses self-report physical activity data that is part of the standard TRACTS assessment battery (see below for details). Measurement of self-report physical activity was added to the TRACTS assessments in October of 2018. At this time, physical activity data has been collected from a total of 55 participants at their first Follow-up. Based on past recruitment and current retention rates, there will be about 250 cases with complete physical activity data by the end of the third year of this project.

Aim 2 examines diet quality as a potential mechanism linking PTSD to cardiometabolic health and functioning in post-9/11 Veterans from that TRACTS longitudinal cohort study. Similar to Aim 1, data that is being collected by TRACTS to accomplish this aim. A self-administered web-based 24-hour dietary recall will be used to capture dietary intake and assess diet quality (see below for details). There will be approximately 200 cases with complete dietary intake data by the end of year 4 of the study.

Supplemental Aim, consecutively enrolled TRACTS participants will be invited to participate in this pilot study separately from their standard TRACTS visits. This pilot study will consist of two onsite visits at VABHS, approximately 1-2 weeks apart. In Visit 1, participants will complete a physical activity questionnaire, several mental and physical health assessments, and receive training on how to properly wear an accelerometer. Participants will then be instructed to wear an accelerometer for at least 7 days before returning to VABHS for Visit 2, approximately 9-14 days later. In Visit 2, participants will return the accelerometers, complete a physical activity questionnaire, and a cardiorespiratory fitness test. The goal is to recruit at least 25 participants a year for this study and aim to obtain 100 participants with complete data by the end of year 4 of the study.

Aims 1 and 2 Data Analytic Plan. This aims will use regression-based methods for mediation analysis to explore whether physical activity and/or diet quality mediates the relationship between PTSD and cardiometabolic health and functioning in post-9/11 Veterans. Given the modest sample size, the investigators will use bootstrapped standard errors to reduce potential bias. The investigators will conduct these analyses using the SAS statistical platform. Importantly, the procedures for conducting the proposed analyses using SAS has been previously established. Below, the investigators propose a hypothesized model to test (i.e., physical activity/diet quality as a mediator). However, there are many plausible alternative models (e.g., physical activity/diet quality as a moderator), as well as numerous potential confounders (e.g., age, gender, past or current mental illness, combat exposure, and TBI history). As such, in addition to this proposed model the investigators will evaluate potential alternative models in exploratory analyses.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Aim 1: Total Physical Activity (self-report)

时间窗: 1 year follow-up

Self-reported physical activity over the past year, using the International Physical Activity Questionnaire (IPAQ)

Aims 1 and 2: Cardiometabolic Health

时间窗: Baseline and 1 year follow-up

Cardiometabolic health will be determined by a positive or negative diagnosis of metabolic syndrome

Aim 2: Diet Quality

时间窗: 1 year follow-up

Diet quality over the past year, using the Healthy Eating Index (2015 version)

次要结局

  • Supplement aim: PTSD symptoms(Visit 1 (day 1))
  • Supplemental aim: Physical Activity(Starting at Visit 1 (day 1) and continuing until Visit 2 (9-14 days later))
  • Supplemental aim: Cardiorespiratory fitness(Visit 2 (9-14 days after Visit 1))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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