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Brazilian Version of an Intervention to Support Healthy Lifestyle Adoption Post-stroke - iVIDAVC
Sponsor: Federal University of Minas Gerais
Summary
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.
Official title: Brazilian Version of a Behavior Change Intervention to Support Healthy Lifestyle Adoption After Stroke - iVIDAVC: Protocol for a Pilot Randomized Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-09
Completion Date
2027-07
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
iVIDAVC
The 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
Participants 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.
Locations (1)
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil