NCT07119047

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A non-probabilistic sample will be recruited from the community. Recruitment strategies include: referrals (e.g, phone numbers obtained from other research projects and university extension programs) and advertisements (e.g. physical folders distributed in public places and electronic pamphlets published on social media). All subjects will be informed about the study procedures and will provide written consent. The intervention and data collection will take place in a university laboratory setting. Two research assistants will enter the data into a statistical software package and verify any missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. All individuals will receive an identification code to ensure anonymity. A researcher, not involved in carrying out the intervention, will be responsible for carrying out the statistical analyses.

Conditions

• Stroke

Interventions

Type	Name	Description
BEHAVIORAL	A Brazilian adaptation of the Irish intervention "iHELP Stroke"	The intervention comprises a set of interactive experiential learning activities. A physiotherapist will serve as the coordinator, and other healthcare professionals will be invited to participate as guest speakers. The educational session aims to provide knowledge about stroke (what stroke and recurrent stroke are, their signs and symptoms, and lifestyle-related risk factors). The individual session aims: (1) to identify the current self-reported health status after stroke; (2) to recognize and raise awareness of risk factors associated with lifestyle-related behaviors, including the setting of behavior change goals, which are structured using the SMART Goals method; and (3) to identify the individual's preferences and ability to participate in the intervention program. Each group session comprises six components covered across the six sessions: education, goal setting, physical activity participation, emotional self-regulation, skill training, and peer learning.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-08-01
• Completion: 2025-10-01
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: Brazil