A Clinical Trial of SystemCHANGE to Improve Exercise, Diet and Health in HIV-Infected Adults

Completed · Not applicable

Conditions studied: HIV, Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT02553291

Run by

Case Western Reserve University

People needed

109

Starts

2014-11-01

Expected to finish

2016-11-01

Last updated by the study team

2017-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• aged >18 years
• have been diagnosed with HIV
• Receiving HIV antiretroviral therapy for at least 3 months
• have had at least one HIV viral load <400 copies/mL in the past 12 months
• at high lifetime risk for developing CVD (>females with >20% risk and males >30% risk using the Body-Mass Index (BMI) -based Framingham 30-year risk calculator)
• if on statin therapy, must have been on statins for the past 6 months

You may not qualify if…

• have an absolute or relative medical contraindication for exercise determined by the AHA criteria
• currently meet the Department of Health and Human Services recommendations for exercise (i.e.,150 minutes/week of moderate-intensity exercise or 75 minutes of vigorous-intensity exercise)
• have uncontrolled diabetes (HgA1c<8 at screening visit)
• are unable to understand spoken English
• expect to move out of the area within 12 months
• planning on becoming pregnant in the next six months
• are enrolled in a formal exercise, diet, or weight loss programs
• a household member who is or will be enrolled in the study

Where it is running

• Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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