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.
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;
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.
Parallel
iVIDAVC
BehavioralThe iVIDAVC intervention comprises interactive experiential learning activities coordinated by a physiotherapist, with invited healthcare professionals as guest speakers. The educational session aims to provide knowledge about stroke, signs and symptoms, and lifestyle-related risk factors, as well as the importance of adopting healthy behaviors to reduce the risk of recurrent stroke. The individual session aims to (1) identify the participant's self-reported health status after stroke; (2) increase awareness of lifestyle-related risk factors and support the setting of behavior change goals, using the SMART Goals method; and (3) identify the participant's preferences and ability to participate in the intervention. Each group session includes six components: education, goal setting, physical activity, emotional self-regulation, skills training, and peer learning. These components are addressed across the group sessions and are organized in different ways according to each session.
Telephone support
BehavioralParticipants will receive an educational session and an initial individual session. The educational session will provide information about stroke, signs and symptoms, lifestyle-related risk factors and the importance of adopting healthy behaviors. The individual session will aim to (1) identify the participant's self-reported health status after stroke; (2) identify and increase awareness of lifestyle-related risk factors and establish 3 behavior change goals using the SMART Goals method; and (3) identify the participant's preferences and ability to participate in the program. A physiotherapist will call each participant on a fixed day and at a fixed time agreed upon in advance with the participant. Participants will have the opportunity to clarify any questions regarding the achievement of the goals. The number of telephone support contacts will correspond to the total number of group sessions delivered to experimental group. Participants will not participate in the group sessions.
Feasibility of recruitment
It will be determined by the ratio between the total number of eligible individuals (EI) and the total number of screened individuals (SI) (measure=EI/IS), and by the ratio between the total number of eligible individuals (EI) and the total number of recruited individuals (RI) (measure=EI/RI).
Feasibility of intervention (retention)
It will be determined by the ratio between the total number of individuals who completed the proposed intervention program and the total number of individuals who started the proposed intervention program.
Feasibility of intervention (attendance)
It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered.
Feasibility of intervention (follow-up of individuals)
It will be determined the ratio between the total number of individuals who remained in the same group to which they were initially allocated until follow-up and the total number of individuals who were allocated.
Attainment of behavioral change goals
Goal Attainment Scaling (GAS). The GAS T-score will be used to assess the degree of attainment of the participant's behavioral change goals. Changes in the GAS T-score will be assessed from baseline to post-intervention and from post-intervention to the 4-week follow-up to determine whether goal attainment is maintained, increased, or decreased over time.
Knowledge about stroke
Knowledge about stroke will be assessed using six questions addressing participants' knowledge of stroke, its signs and symptoms, risk factors for stroke occurrence, the possibility of experiencing a recurrent stroke, the role of healthy lifestyle behaviors in reducing the risk of recurrent stroke, and how to establish goals to maintain a healthy lifestyle. Participants will provide a yes/no response to each question and describe what they know about each topic. Changes in knowledge will be assessed from baseline to post-intervention and from post-intervention to the 4-week follow-up.
Self-efficacy for behavior change
Self-efficacy for behavior change will be assessed using five statements addressing participants' perceived ability to independently maintain a healthy lifestyle, establish goals, develop action plans to achieve healthy lifestyle goals, develop coping strategies to overcome barriers to maintaining a healthy lifestyle, and self-monitor and record their lifestyle behaviors. Each statement will be rated on a five-point Likert scale ranging from "strongly agree" to "strongly disagree." Changes in self-efficacy will be assessed from baseline to post-intervention and from post-intervention to the 4-week follow-up.
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Federal University of Minas Gerais
Lead sponsor
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Collaborator
Worldwide Universities Network
Collaborator
Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais
Collaborator
