NCT07809269 Brazilian Version of an Intervention to Support Healthy Lifestyle Adoption Post-stroke - iVIDAVC
| NCT ID | NCT07809269 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Minas Gerais |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-09 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-09 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07809269 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07809269 currently recruiting?
Yes, NCT07809269 is actively recruiting participants. Contact the research team at cdcmf@ufmg.br for enrollment information.
Where is the NCT07809269 trial being conducted?
This trial is being conducted at Belo Horizonte, Brazil.
Who is sponsoring the NCT07809269 clinical trial?
NCT07809269 is sponsored by Federal University of Minas Gerais. The trial plans to enroll 24 participants.
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