Over 65% of stroke survivors are either overweight or obese, and a projected 4.98 million stroke survivors in the USA have multiple cardiovascular risk factors . Stroke survivors are at significant risk for de-conditioning , elevated inflammatory markers , and insulin resistance , which subsequently increases risk for secondary stroke and cardiovascular disease [5, 6]. Engaging in healthy behaviors, such as physical activity, good sleep hygiene, and nutrition, to facilitate energy balance may help reduce the risk of secondary conditions and ultimately improve physical function and quality of life in stroke survivors [5, 7].
However, stroke survivors can experience many barriers to engaging in a healthy lifestyle to achieve energy balance . Mental and physical impairments interacting with a non-supportive environment can create multiple challenges to engagement in healthy behaviors, which can perpetuate a disabling cycle . Specifically, inactivity, unhealthy eating, and poor sleeping habits can lead to obesity. Obesity can increase mobility problems, fatigue, depression, and further difficulties engaging in healthy behavior. Supporting stroke survivors to achieve energy balance and a healthy body weight may be a strategy to counteract the disablement process.
Most studies examining lifestyle interventions in stroke survivors have focused on promoting physical activity and/or teaching self-management skills , which only partially addresses behaviors associated with achieving energy balance . Thus, effective strategies to promote weight loss in stroke survivors remain elusive. Research in the general population indicates weight management interventions should target both physical activity and nutrition , and that promoting good sleep hygiene may be an additional strategy to facilitate weight loss . Furthermore, research in people with disabling conditions indicates that impairments often create barriers to engagement in healthy behaviors, but that utilizing self-management skills and having ample social support can facilitate overcoming such health-related barriers . Thus, based on research in the general population and in people with disabling conditions, we contend that an effective weight management intervention in stroke survivors should target physical activity, nutrition, sleep, and self-management skills, as well as utilize strategies to foster a supportive social environment.
Shirley Moore recently developed such an intervention approach called SystemCHANGE™ , a new behavior change intervention drawing from social ecological theories [15–17]. SystemCHANGE™ focuses on redesigning the environment using trial-and-error ‘experiments’ to achieve a specific goal. SystemCHANGE™ is in contrast to cognitive-behavioral interventions that focus on changing a person’s viewpoint of a situation and increasing motivation. In SystemCHANGE™, individuals are taught a set of skills to assist them in incorporating habitual lifestyle behaviors into their daily systems so they succeed despite wavering motivation. Strategies include identifying a chain of steps/events that comprise the system in which the desired change is to occur, keeping track of data about the system process to understand it, implementing short trials of possible improvement solutions, evaluating success by reviewing data, and making provisions for holding the gains. Given the novelty of SystemCHANGE™ to focus on an individual’s surrounding environment rather than an individual’s motivation and willpower to change behavior, this approach is now being tested in various population segments (for example, overweight children and patients with HIV). We propose to adapt the SystemCHANGE™ intervention approach to promote weight loss in overweight and obese stroke survivors. This study will represent the first empirically-examined comprehensive lifestyle intervention designed to target physical activity, nutrition, and sleep to promote weight loss in stroke survivors.
The specific aims are to engage stroke survivors and their families as co-designers to adapt the SystemCHANGE™ intervention, and then conduct a randomized controlled pilot study to provide preliminary estimates of the intervention’s efficacy in 35 stroke survivors. Herein, we will focus on describing the methodology for the pilot randomized controlled trial rather than the qualitative methodology. The pilot study will provide effect size estimates on the following primary outcomes: body weight and patient-reported and objective outcomes of health and function. Secondary outcomes include questionnaires on symptoms, healthy behaviors, psychosocial mediators, and biomarkers of cardiovascular risk. The central hypothesis of the study is that the SystemCHANGE™ intervention will help overweight and obese stroke survivors lose 5% of their weight, thereby improving health and function. Hypothesized mechanisms of action will involve significant improvements in healthy behaviors, symptoms, psychosocial constructs, and cardiovascular risk.