Brazilian Version of an Intervention to Support Healthy Lifestyle Adoption Post-stroke - iVIDAVC

Brazilian Version of a Behavior Change Intervention to Support Healthy Lifestyle Adoption After Stroke - iVIDAVC: Protocol for a Pilot Randomized Study

Introduction: Stroke presents a high global burden, particularly in low- and middle-income countries such as Brazil. Stroke secondary prevention, in which the adoption of healthy lifestyle behaviors is a key component, is an important strategy for reducing the global burden of stroke. Effective, evidence-based behavioral interventions are needed to support healthy lifestyle adoption after stroke. The "iHELP Stroke: Improving Health and Lifestyle Programme after Stroke", developed in Ireland, is a multimodal behavioral change intervention designed to support healthy lifestyle adoption after stroke. This intervention was adapted to the Brazilian context, following the ADAPT guidance, and was renamed iVIDAVC (Brazilian Portuguese: Intervenção para Melhorar a Saúde e o Estilo de Vida Pós-AVC; corresponding English title: Intervention to Improve Health and Lifestyle After Stroke). A phase I feasibility study of the adapted intervention was completed in July 2025. The next step is to conduct a pilot randomized clinical trial (RCT) to further assess the feasibility of the study procedures and intervention and to obtain preliminary estimates of clinical outcomes.

Objective: To assess the feasibility of a pilot RCT of the iVIDAVC, a Brazilian version of a behavior change intervention to support the adoption of healthy lifestyle behaviors after stroke, and to explore its preliminary effects on goal attainment among individuals with stroke in Brazil.

Methods: This is a prospective, pilot RCT (Phase II), with two parallel groups, 1:1 allocation, concealed allocation, and blinded outcome assessment. Twenty-four adults with a clinical diagnosis of stroke, living in the community and reporting the need to change at least one lifestyle-related behavior will be recruited in Belo Horizonte, Brazil, and randomly allocated to an experimental group or a control group (12 participants per group). The experimental group will receive the iVIDAVC intervention, a Brazilian version of a behavior change intervention to support the adoption of healthy lifestyle behaviors after stroke, consisting of one educational session, one individual session, and initially six weekly group sessions, with the possibility of additional group sessions according to participants' needs. The control group will receive the educational and individual sessions and remote support for six weeks. Feasibility outcomes will include recruitment, intervention, outcome measurement, blinding, and costs. Clinical outcomes will include the degree of attainment of behavioral change goals, knowledge about stroke, and self-efficacy for behavior change. Assessments will be conducted at baseline, immediately after the intervention, and four weeks after the intervention. Descriptive and estimation-based statistics will be used, without formal hypothesis testing.

Conclusions: This pilot RCT will provide information on the feasibility of the study procedures and the delivery of the iVIDAVC, a Brazilian version of a behavior change intervention to support the adoption of healthy lifestyle behaviors after stroke, as well as preliminary estimates of changes in the GAS T-score. The findings will inform refinements to the intervention and study procedures and support the planning of a future larger-scale RCT.

A non-probabilistic sample of 24 participants will be recruited from the community in Belo Horizonte, Brazil. Recruitment strategies will include the distribution of printed flyers in strategic locations, contact with health professionals and researchers, social media and telephone communication, outreach through stroke support groups, dissemination through university and organizational websites and social media, and invitations to participants from a university extension program. All participants will be informed about the study procedures and, upon agreeing to participate, will provide written informed consent. The intervention and outcome assessments will be conducted in a university laboratory setting. A trained researcher blinded to group allocation will be responsible for collecting sociodemographic, anthropometric, and clinical data at baseline, immediately after the intervention, and four weeks after the intervention. Two independent examiners, also blinded to group allocation, will enter the data into statistical software and verify the presence of missing or inconsistent values. Original paper forms will be stored securely, and electronic files will be accessible only to the research team. All participants will be assigned a unique identification code to ensure anonymity. Statistical analyses will be conducted by an independent researcher who will be blinded to group allocation.

Inclusion Criteria:

• Clinical diagnosis of stroke, at any stage;
• Age ≥ 18 years;
• Discharged from hospital and living in the community;
• Ability to walk independently with or without a walking device;
• Self-identified need to change at least one of the following lifestyle-related behaviors: physical inactivity, unhealthy diet, smoking, harmful alcohol use, or non-adherence to prescribed medication, or inadequate management of psychosocial factors, such as anxiety, stress, or depression.

Exclusion Criteria:

• Positive screening test for possible cognitive alterations;
• Pain or other adverse health conditions that compromise the performance of the proposed intervention program, such as vestibular disorders, severe arthritis, or any other diagnosed disease of the nervous system;
• Presence of comprehensive and/or expressive aphasia.