The feasibility and acceptability of a web-based physical activity for the heart (PATH) intervention designed to reduce the risk of heart disease among inactive African Americans: Protocol for a pilot randomized controlled trial

Contemp Clin Trials. 2021 May:104:106380. doi: 10.1016/j.cct.2021.106380. Epub 2021 Mar 31.

Abstract

Background: Many studies have used the internet to promote physical activity (PA) in several settings, including the home environment, but few have been tailored for African Americans (AAs). To address this research gap, we conducted focus groups with AAs to inform the development of a web-based intervention, Physical Activity for The Heart (PATH), that leverages openly accessible platforms, such as YouTube, to promote PA in any setting.

Purpose: To describe the rationale and design of a pilot randomized clinical trial (RCT), that examines the feasibility and acceptability of the PATH intervention among 30 AA adults aged 40--70 years without history of cardiovascular disease.

Methods: A 12-week, single-site, wait-listed RCT with subjects randomized 1:1 to either: 1) treatment group - participants receive the PATH intervention, including the online portal and twice a month phone calls from a PA coach, or 2) attention control group - participants receive a self-help PA handout and twice a month general health newsletter. All participants self-monitor step count using actigraphy. The primary outcomes of this 12-week, pilot RCT are recruitment, retention, and adherence to self-monitoring (Actigraph wear time) and the intervention protocol (PATH utilization). The secondary outcomes include changes in PA (step count, moderate-to-vigorous PA, exercise self-efficacy), and cardiometabolic risk (HbA1C, HDL, LDL, total cholesterol, type 2 diabetes risk score, percent body fat, weight, and waist circumference) from baseline to 12 weeks.

Conclusions: This study will provide PATH intervention feasibility and acceptability data among inactive AA adults and will inform a future, full-scale RCT testing efficacy.

Keywords: Cardiometabolic risk; Physical activity; Physical activity tracker; Randomized controlled trial; Self-monitoring; Technology; Web-based.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Black or African American
  • Exercise
  • Feasibility Studies
  • Heart Diseases*
  • Humans
  • Internet-Based Intervention*
  • Pilot Projects
  • Randomized Controlled Trials as Topic