A Clinical Trial of SystemCHANGE to Improve Exercise, Diet and Health in HIV-Infected Adults
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, HIV / AIDS |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/20/2017 |
| Start Date: | November 2014 |
| End Date: | November 2016 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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