Brazilian Adaptation of an Intervention Developed in Ireland to Promote Healthy Lifestyle Behaviors Post-stroke: Protocol for a Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Introduction: Low- and middle-income countries, such as Brazil, are most impacted by the high burden of recurrent stroke. These countries also lack structured interventions to promote the adoption of healthy lifestyle behaviors in the context of stroke secondary prevention. In contrast, high-income countries, such as Ireland, which invest more in research, have more advanced studies on this topic. However, before implementing interventions developed in countries like Ireland in middle-income countries like Brazil, it is necessary to adapt them to account for cultural and socioeconomic differences. Furthermore, once the adaptation is made, it is essential to investigate the feasibility of implementing the intervention in the new context.

Objective: To investigate the feasibility of implementing the Brazilian adaptation of the Irish intervention iHELP Stroke: Improving Health and Lifestyle Programme, which aims to promote the adoption of healthy lifestyle behaviors post-stroke. Methodology: This is a phase 1 interventional feasibility study, using a pre- and post-intervention design, to be conducted with ten individuals post-stroke, residing in Belo Horizonte, MG, Brazil. The intervention will consist of eight sessions: one educational session, one individual session, and six group sessions, held weekly. The outcomes of interest will include feasibility (recruitment, intervention, and measurement) and clinical outcomes (achievement of the main goal defined by the participants and the number/proportion of participants who meet this goal). Descriptive statistics will be used for analysis.

Conclusions: The results of this feasibility study will provide valuable insights for designing subsequent phases of a clinical trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinical diagnosis of subacute or chronic stroke;

• Age ≥ 18 years;

• Discharged from hospital and living in the community;

• 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.

Locations
Other Locations
Brazil
Universidade Federal de Minas Gerais
RECRUITING
Belo Horizonte
Contact Information
Primary
Christina Faria, PhD
cdcmf@ufmg.br
+55 (31) 34097448
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 10
Treatments
Experimental: A Brazilian adaptation of the Irish intervention iHELP Stroke
The adaptation process of the Irish intervention iHELP Stroke: Improving Health and Lifestyle Programme for the Brazilian context followed the recommendations outlined in the ADAPT guidance (Moore et al., 2021). The adaptations proposed, discussed, and implemented aimed to tailor the intervention to Brazilian specificities, including geographic, cultural, economic, ethical, legal, political, organizational, service-related, and practice-related factors. Participants will undergo the Brazilian version of the adapted iHELP Stroke intervention over eight weeks. This includes one educational session (one hour), an initial individual session (one hour), and six group sessions (two hours each), totaling eight weeks of intervention.
Related Therapeutic Areas
Sponsors
Collaborators: Coordenaçao de Aperfeiçoamento de Pessoal de Nível Superior, FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais, Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Worldwide Universities Network
Leads: Federal University of Minas Gerais

This content was sourced from clinicaltrials.gov