Action for better brain health among people living with HIV: protocol for a randomized controlled trial

BMC Infect Dis. 2021 Aug 20;21(1):843. doi: 10.1186/s12879-021-06540-7.

Abstract

Background: Lifestyle changes can protect or improve brain health in older adults. However, sustained lifestyle change is difficult for everyone and may be more difficult for those with executive dysfunction, including some people living with HIV. Thus, the key question is how we can improve adherence to the most promising interventions among people living with HIV experiencing cognitive difficulties. Goal management training is a cognitive rehabilitation program that targets executive dysfunction by teaching goal-directed behaviour and self-management. It is a promising means to improve adherence to lifestyle interventions.

Objective: To estimate the extent to which goal management training before a healthy lifestyle program is associated with greater adherence to health recommendations, achievement of health-related goals, and better brain health and health outcomes compared to the healthy lifestyle program alone among people living with HIV.

Methods: Brain Health Now cohort participants with cognitive difficulties or are not aging successfully are eligible. All participants will be given health resources, a health coach, a goal-setting digital application, and access to an online goal-setting workshop. The intervention group will participate in nine 2-h goal management training sessions and then will enter the healthy lifestyle program. Control participants will enter the healthy lifestyle program directly. A total sample of 100 participants will participate for 12 months. The main outcome is adherence to the healthy lifestyle program, defined as the number of weeks where physical activity adherence targets were met (150 min per week, measured with an activity monitor). Weekly social activities will be captured via self-report with confidential photo validation. We will send weekly health state reports to the participants. Downstream outcomes include cognitive ability, health-related quality of life, mobility, vascular risk profile, and social network size. We will analyze the data using a linear regression model.

Discussion: This project is the first to test whether goal management training can augment adherence to health recommendations among individuals with cognitive difficulties. If successful, behavioural interventions such as goal management training could be implemented as an adjunct to lifestyle interventions in other clinical populations.

Trial registration: This trial was registered on clinicaltrials.gov (NCT04345484) on April 14, 2020, https://clinicaltrials.gov/ct2/show/NCT04345484?term=NCT04345484&draw=2&rank=1 .

Keywords: Brain health; Cognitive rehabilitation; Goal management training; HIV; Healthy lifestyle; Physical activity.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Aged
  • Brain
  • Exercise
  • HIV Infections* / complications
  • Humans
  • Life Style
  • Quality of Life*
  • Randomized Controlled Trials as Topic

Associated data

  • ClinicalTrials.gov/NCT04345484