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

https://doi.org/10.1016/j.jstrokecerebrovasdis.2020.105323Get rights and content

Abstract

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.

Section snippets

Background

Adherence to a combination of five healthy lifestyle practices – eating ≥ 5 servings of fruits/vegetables/day, exercising over 12 times per month, maintaining a body mass index (BMI) of 18.5–29.9 mg/kg2, drinking alcohol in moderation (1 drink/day for women and 2 drinks/day for men), and not smoking – lowers the risk of cerebrovascular events1,2 and is independently associated with lower mortality after stroke.3,4 Combinations of these healthy lifestyle factors have been associated with lower

Setting and population

Details of the methods have been published.15 Briefly, individuals were recruited between October 2012 and March 2015 from outpatient clinics at Rancho Los Amigos National Rehabilitation Center (Rancho), one of the US’ largest rehabilitation facilities, and part of the Los Angeles County Department of Health Services safety-net system. Inclusion criteria were: age ≥ 40 years; English- or Spanish- speaking; TIA or ischemic stroke ≥ 3 months prior to enrollment, and ability to participate in

Results

One hundred participants were enrolled; 49 were randomized to intervention and 51 to usual care. Among 100 participants enrolled, mean age was 58 (SD 9) years, 62% were men, 68% were Hispanic; two thirds were born outside of the US and spoke Spanish most of the time, and one out of four did not attend high school (Table 1). Most had mild strokes, minimal disability, and competing needs (Table 2). The intervention and control arms were balanced on most factors, except a higher proportion of

Discussion

In this pilot RCT, we determined that a six-week OT-based lifestyle intervention for improving lifestyle habits after stroke was feasible and well-received. Effect sizes were small for all outcomes. The mid-trial formative evaluation informed development of a formal training manual for OTs in the second phase.

There are numerous potential explanations for the small effect sizes. First, nearly one third of participants randomized to the intervention did not attend any sessions. Second,

Funding

American Heart Association National Scientist Development Award (11SDG7590160). Trial Registration: NCT01550822 (PI: Towfighi).

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Acknowledgments

Dr. Florence Clark, PhD, OTR/L for developing the Lifestyle Redesign® intervention. Karina Martinez, BS and Cynthia Munoz, MSW for recruitment and outcomes collection.

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