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

NCT02553291 | Completed DMC

• 1 other identifier: CaseWestern
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Exercise as Measured by Waist-Worn Actigraph

  Measured by Actigraph

  6 months

Secondary Outcomes (1)

• Cardiorespiratory fitness measured by VO2 max derived from a stress test

  6 months

Study Arms (2)

SystemCHANGE

EXPERIMENTAL

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.

Behavioral: SystemCHANGE

Control

ACTIVE COMPARATOR

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)

Behavioral: Control

Interventions

SystemCHANGE BEHAVIORAL

Also known as: BOBCAT Study

SystemCHANGE

Control BEHAVIORAL

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Case Western Reserve University: lead
• American Heart Association: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.

  PMID: 32205788 DERIVED

• Moore SM, Musil CM, Jack AI, Alder ML, Fresco DM, Webel A, Wright KD, Sattar A, Higgins P. Characterization of Brain Signatures to Add Precision to Self-Management Health Information Interventions. Nurs Res. 2019 Mar/Apr;68(2):127-134. doi: 10.1097/NNR.0000000000000331.

  PMID: 30540702 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: September 17, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

US (1)