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

NCT07809269 | Recruiting

• 1 other identifier: CAAE: 95547126.9.0000.5149
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Healthy Lifestyle; Pilot Study; Clinical Trial; Secondary Prevention

Outcome Measures

Primary Outcomes (13)

• 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).

  Baseline, pre-intervention

• 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.

  At baseline and immediately post-intervention

• 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.

  At baseline and immediately post-intervention

• 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.

  At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)

• Feasibility of intervention (adherence to planned session components)

  It will be assessed by comparing the content delivered during each session with the content specified in the intervention protocol. The proportion of planned session components delivered will be recorded.

  At each intervention session, over the 8- to 12-session intervention period

• Feasibility of intervention (safety)

  It will be determined by the number and reasons of adverse events (e.g. pain, falls, hospitalization, and death) identified during the period of intervention and follow-up of the individual.

  During the intervention (8 to 12 sessions) and follow-up (4 weeks after the end of the intervention)

• Acceptability of the intervention

  Acceptability of the intervention will be assessed using participant feedback on five-point Likert scales, with the following response options: "totally agree", "partially agree", "neither agree nor disagree", "partially disagree", and "totally disagree". Participants will rate the following items: (1) overall satisfaction with the activities conducted by the health professional during the intervention; (2) helpfulness of the educational materials in supporting the adoption of a healthy lifestyle; (3) satisfaction with the overall time required for the intervention, considering the total number of weekly sessions; (4) satisfaction with the duration of the intervention sessions, including 1 hour for the educational session, 1 hour for the individual session, and 2 hours for group sessions; and (5) overall satisfaction with the intervention. These scales were informed by previous studies.

  Immediately post-intervention

• Feasibility of intervention (perceived effectiveness: lifestyle)

  It will be determined by the following question: "Comparing how it was before you performed the intervention and now, do you consider your lifestyle to be healthier: strongly agree, partially agree, neither agree nor disagree, partially disagree, strongly disagree".

  Immediately post-intervention and follow-up (4 weeks after the end of the intervention)

• Feasibility of intervention (perceived effectiveness: overall health)

  It will be assessed using participant feedback to the following question: "Compared to before participating in the intervention, how would you rate your overall health now?". Participants will rate their perceived change in overall health using five response options: "much better", "somewhat better", "about the same", "somewhat worse", and "much worse". This assessment will capture participants' perception of changes in their overall health following participation in the iVIDAVC intervention.

  Immediately post-intervention and follow-up (4 weeks after the end of the intervention)

• Feasibility of intervention (perceived effectiveness: healthy lifestyle)

  It will be assessed using participant feedback to the following question: "Compared to before participating in the intervention, how would you rate your lifestyle now?". Participants will rate their perceived change in lifestyle using five response options: "much better", "somewhat better", "about the same", "somewhat worse", and "much worse". This assessment will capture participants' perception of changes in their lifestyle following participation in the iVIDAVC intervention.

  Immediately post-intervention and follow-up (4 weeks after the end of the intervention)

• Feasibility of measurement

  It will be determined by the percentage of clinical outcomes successfully measured (i.e., the ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured).

  At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)

• Feasibility of blinding the outcome assessor

  The feasibility of blinding the outcome assessor will be determined by the number and percentage of participants for whom the blinded outcome assessor correctly guesses the treatment allocation.

  Immediately post-intervention and follow-up (4 weeks after the end of the intervention)

• Cost

  Costs associated with staff training (e.g., materials and transportation), recruitment (e.g., telephone calls and printing of folders), screening, assessment of inclusion and exclusion criteria, outcome assessment (e.g., transportation costs for participants and staff, printing of assessment materials, and material costs), and intervention delivery (e.g., telephone calls) will be recorded.

  From the beginning of the study planning through the completion of the intervention and follow-up (4 weeks after the end of the intervention)

Secondary Outcomes (3)

• Attainment of behavioral change goals

  At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)

• Knowledge about stroke

  At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)

• Self-efficacy for behavior change

  At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)

Study Arms (2)

iVIDAVC

EXPERIMENTAL

The iVIDAVC intervention is a multimodal behavior change programme adapted from the iHELP Stroke to the Brazilian context. The adaptation process followed the ADAPT guidance (Moore et al., 2021), with adaptations addressing geographic, cultural, economic, ethical, legal, political, organizational, service-related, and practice-related aspects. The intervention aims to support the adoption of healthy lifestyle behaviors after stroke: healthy eating, physical activity, smoking cessation, safe alcohol consumption, medication adherence, and management of psychosocial factors. It consists of 1 educational session (approximately 1 hour), 1 individual session (approximately 1 hour), and initially 6 weekly group sessions (approximately 2 hours each). The group sessions address 6 components: education, goal setting, physical activity, emotional self-regulation, skills training, and peer learning. Additional group sessions may be offered according to participants' needs, up to a maximum of 10.

Behavioral: iVIDAVC

Telephone support

SHAM COMPARATOR

Participants allocated to the control group will receive the educational session and the initial individual session of the intervention but will not participate in the group sessions. The educational and individual sessions will be delivered in person in a university laboratory setting. Participants will subsequently receive remote telephone support. The number of remote support contacts will correspond to the total number of group sessions delivered to participants in the experimental group, thereby maintaining a comparable intervention period between groups.

Behavioral: Telephone support

Interventions

iVIDAVC BEHAVIORAL

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.

iVIDAVC

Telephone support BEHAVIORAL

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.

Telephone support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• 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

Study Sites (1)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

RECRUITING

Related Publications (6)

• Peniche PC. Comportamentos de estilo de vida saudável no contexto da prevenção secundária do acidente vascular cerebral [tese de doutorado]. Belo Horizonte: Universidade Federal de Minas Gerais; 2025 [cited 2026 Aug 17]. Available from: https://repositorio.ufmg.br/items/f3e9a38a-96b6-496c-af9b-87789c089b20

  BACKGROUND

• Hall P, Lawrence M, Kroll T, Blake C, Matthews J, Lennon O. Reducing risk behaviours after stroke: An overview of reviews interrogating primary study data using the Theoretical Domains Framework. PLoS One. 2024 Apr 26;19(4):e0302364. doi: 10.1371/journal.pone.0302364. eCollection 2024.

  PMID: 38669261 BACKGROUND

• da Cruz Peniche P, Faria CDCM, Hall P, Lennon O. Effectiveness of behavior change and self-management theoretically-informed telehealth interventions for stroke secondary prevention: An overview of systematic reviews. J Telemed Telecare. 2025 Aug;31(7):961-990. doi: 10.1177/1357633X241238779. Epub 2024 Apr 16.

  PMID: 38627913 BACKGROUND

• Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.

  PMID: 26978655 BACKGROUND

• Moore G, Campbell M, Copeland L, Craig P, Movsisyan A, Hoddinott P, Littlecott H, O'Cathain A, Pfadenhauer L, Rehfuess E, Segrott J, Hawe P, Kee F, Couturiaux D, Hallingberg B, Evans R. Adapting interventions to new contexts-the ADAPT guidance. BMJ. 2021 Aug 3;374:n1679. doi: 10.1136/bmj.n1679.

  PMID: 34344699 BACKGROUND

• Hall P, Asaba E, Peniche PC, McCartan D, O'Callaghan G, Lennon O. Stakeholder engagement and the co-design of an intervention template to support healthy lifestyle participation after stroke. Design Health. 2025;9(3):257-279. doi:10.1080/24735132.2025.2506311.

  BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Christina Faria, PhD

CONTACT

+55 (31) 34097448; cdcmf@ufmg.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by a previously trained examiner, blinded to the allocation of groups. All participants will be instructed not to comment on information about the intervention received. The therapist responsible for delivering the intervention will be blinded to the results of participants' assessments. All statistical analyzes will be performed by an independent examiner, blinded to all procedures performed in the study, including with regard to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)