The SENSS (Stress, Exercise, Nutrition, Sleep, Self-management) study: study protocol for a randomized controlled trial to evaluate an integrated, personalized and stepped care lifestyle approach for people with Parkinson's disease.

BACKGROUND

Lifestyle interventions have potential to support people with Parkinson's disease (PD) in self-managing their disease and improving quality of life. Growing evidence suggests positive effects of singular lifestyle interventions, such as physical activity, stress or nutrition. However, several challenges remain. First, despite potential additive and perhaps even synergistic effects, research on combining lifestyle interventions is limited. Second, lifestyle interventions are not routinely addressed as part of standard medical care. Finally, there are significant challenges related to changing behavior and adherence to lifestyle interventions. This study aims to evaluate the effectiveness and cost-effectiveness of an integrated, personalized and stepped care lifestyle approach for people with PD.

METHODS

We will perform a 12-month single-blind randomized controlled trial. We aim to include 256 people with PD, randomized in a 1:1 ratio into a control and intervention group. Both groups receive a clinical assessment with a lifestyle coach and can partake in usual care. The intervention group receives an additional lifestyle intervention, consisting of guidance and interventions on different lifestyle domains: stress, exercise, nutrition, sleep and self-management (the SENSS approach). This intervention is offered remotely according to a stepped care model to personalize the intervention to the participants' needs and abilities. The primary endpoint is the between-group difference in quality of life at 12 months (Parkinson's Disease Questionnaire-39). Secondary endpoints include between-group differences in PD symptoms, health-related outcomes, self-management and personal goals. Cost-effectiveness and the experiences of participants and healthcare professionals will also be explored.

DISCUSSION: This study evaluates the effectiveness of an integrated personalized lifestyle intervention for people with PD on both clinical and socio-economic outcomes. We expect this intervention to improve quality of life and self-management of people with PD, without increasing healthcare costs. We also expect to offer valuable insights into how such an intervention can be integrated into current daily care for people with PD.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT06669455.