Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke.

OBJECTIVES: Although healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors' self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population. MATERIALS AND METHODS: One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence. RESULTS: There were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants. CONCLUSIONS: The HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted. TRIAL REGISTRATION: NCT01550822.

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.