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.

中文翻译：

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中风幸存者生活方式干预试验的结果：中风后的健康饮食和生活方式

目标

尽管健康的生活方式可以减轻中风复发和死亡的风险，但很少有中风幸存者坚持使用，特别是在社会经济上处于不利地位的社区。我们开发并试行了基于职业疗法的生活方式管理干预措施，即“中风后健康饮食和生活方式（HEALS）”，以提高中风幸存者与饮食和身体活动有关的自我管理技能，并在各种安全网人群中对其进行了评估。

材料和方法

一百名患有中风或短暂性脑缺血发作的英语或西班牙语参与者被随机分为6周的职业治疗师主导的小组生活方式干预和常规护理。每六小时2小时的小组会议均包括关于饮食和体育锻炼，同伴交流，设定目标的个人探索以及通过参与相关活动的直接经验的教学演讲。6个月时的主要结局是体重指数，水果/蔬菜摄入量和体育锻炼的变化。次要结果包括腰围，吸烟，血压，高密度脂蛋白，低密度脂蛋白，甘油三酸酯，总胆固醇，糖基化血红蛋白水平，护理质量和护理观念的变化。确定作用大小以准备进行更大的随机对照试验，以检测主要结果的差异。嵌套的形成性评估评估了促进因素以及实施，接受和干预依从性的障碍。

结果

6个月时主要或次要结局无明显变化。所有结果的效应值均很小（<0.2）。焦点小组参与者建议通过更多的会议，中风和血管危险因素的更多信息，跨学科方法，额外的家庭参与和激励措施来延长干预计划的持续时间。提供商建议延长程序持续时间，增加培训，进行保真度检查以确保标准化程序交付，并为参与者提供更多激励措施。

结论

在安全网环境中，HEALS干预是可行的，但效果较小。可能需要进行较长时间的干预，并进行干预保真度检查。

试用注册

NCT01550822。