A Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Design of Healthy Eating and Lifestyle after Stroke (HEALS)

Background Stroke survivors have high rates of subsequent cardiovascular and recurrent cerebrovascular events, and mortality. While healthy lifestyle practices - including a diet rich in fruits and vegetables, limited alcohol intake, and regular physical activity - can mitigate these outcomes, few stroke survivors adhere to them. Minorities from socioeconomically disadvantaged communities who obtain care in safety-net health systems experience the most barriers to implementing healthy lifestyle changes after stroke. Purpose To report the design of Healthy Eating and Lifestyle After Stroke (HEALS), a randomized controlled trial (RCT) was designed to test the feasibility of using a manualized, lifestyle management intervention in a safety-net setting to improve lifestyle practices among ethnically diverse individuals with stroke or transient ischemic attack (TIA). Methods Design: Pilot RCT. Participants: Inclusion criteria: 1) Adults (≥40 years) with ischemic stroke or TIA (≥ 90 days prior); 2) English- or Spanish-speaking. Setting: Outpatient clinic, safety-net setting. Intervention: Weekly two-hour small group sessions led by an occupational therapist for six weeks. The sessions focused on implementing nutrition, physical activity, and self-management strategies tailored to each participant's goals. Main Outcome Measures: Body mass index, diet, and physical activity. Conclusions Recruitment for this study is complete. If the HEALS intervention study is feasible and effective, it will serve as a platform for a large-scale RCT that will investigate the efficacy and cost-effectiveness of life management interventions for racially and ethnically diverse, low-income individuals with a history of stroke or TIA who seek healthcare in the safety-net system.