A Clinical Trial of SystemCHANGE to Improve Exercise, Diet and Health in HIV-Infected Adults
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|ClinicalTrials.gov Identifier: NCT02553291|
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : July 19, 2017
HIV was once a fatal diagnosis, but due to treatment advances it is no longer a death sentence. Today, HIV-infected adults face a new challenge to their health; they are developing cardiovascular disease (CVD) earlier and more frequently than those not HIV-infected. Reasons for this include toxic effects of HIV medications and activation of the immune system. Preventing cardiovascular disease in HIV-infected adults will help them live healthier lives; however, there is a lack evidence to help us to achieve this goal. Exercise prevents cardiovascular disease, but it is often not addressed in HIV care, due, in part, to a lack of practical interventions targeting this population. This study will address this problem by testing an intervention to improve and maintain exercise in HIV-infected adults.
This study will examine the impact of an innovative and sustainable intervention, adapted to the unique medical and psychosocial needs of HIV-infected adults, called SystemCHANGE-HIV. It consists of six sessions to help redesign an individual's environment and routines to increase exercise.This is a randomized trial in which half of the subjects will participate in the intervention and half will participate in a control condition. Measures include assessments of exercise, fitness, and the markers of cardiovascular health before and after the intervention to see if, and how, they changed.
|Condition or disease||Intervention/treatment||Phase|
|HIV Cardiovascular Disease||Behavioral: SystemCHANGE Behavioral: Control||Not Applicable|
Emerging evidence suggests that HIV infection is associated with a 1.5-2-fold higher risk of cardiovascular disease. This may be due, in part, to an increase in cardiometabolic risk factors related to the toxic effects of HIV medications, immune activation, and chronic inflammation. Interventions to prevent cardiovascular disease, accounting for the unique medical and psychosocial needs of HIV-infected adults, are needed.
Exercise has been shown to improve cardiometabolic risk and decrease cardiovascular disease. It has further been shown to improve cardiometabolic risk factors in some groups of HIV-infected adults in brief and intensely supervised trials. However, how to sustain exercise in this population with practical and scalable interventions that can be implemented in the home setting (i.e., free-living exercise) is unknown. The purpose of this is to test a novel, evidence-based intervention, SystemCHANGE-HIV, which holds promise for improving exercise in HIV-infected adults.
SystemCHANGE-HIV is a new behavior-change program that is based on a systems re-design model, in which the individual's daily routines are composed of a set of habits (behaviors) that can be changed. The intervention engages participants in a series of self-designed experiments to test ways to change their behaviors. The program involves six weekly group sessions to teach behavior-changing and exercise-improvement strategies, followed by monthly telephone booster sessions to encourage maintenance of beneficial effects. SystemCHANGE has significantly improved exercise adherence and cardiovascular risk factors in HIV-uninfected adults. The specific aims of our study are to (1) evaluate the 3-month and 6-month effects of SystemCHANGE-HIV on the amount and intensity of free-living exercise, and (2) describe the impact of SystemCHANGE-HIV on fitness (VO2 max) and cardiometabolic health.
To accomplish these aims, this is a longitudinal, randomized controlled trial (n=105) comparing the effects SystemCHANGE-HIV to those of an attention-control condition. The outcomes will be assessed for efficacy using biological and behavioral evaluations including: actigraphy, fitness assessments, and clinical laboratory assessments.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Subjects will participate in SystemCHANGE behavioral intervention focusing on diet and exercise. This six-session intervention focuses on system redesign of an individual's interpersonal environment and daily routines using small self-designed experiments to increase healthy behavior.
Other Name: BOBCAT Study
Active Comparator: Control
Subjects randomized to the control group will receive an usual care condition and pamphlets on diet and exercise from the U.S. Department of Agriculture and the American Heart Association (AHA)
- Exercise as Measured by Waist-Worn Actigraph [ Time Frame: 6 months ]Measured by Actigraph
- Cardiorespiratory fitness measured by VO2 max derived from a stress test [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553291
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|