Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino

NCT ID: NCT06517459

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2026-10-31

Brief Summary

The purpose of this trial is to examine weight loss for Hispanic/Latino people with stroke (CVA) who take part in a healthy lifestyle program that has been culturally modified for Hispanic/Latino people

Detailed Description

Weight gain greatly increases the risk of chronic diseases such as diabetes, metabolic syndrome, pulmonary and heart disease. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight-loss program that has been used extensively with the general population and with people after CVA, however, it is not adapted to be linguistically and culturally appropriate for Latino persons post stroke. We will modified the program to meet the needs of Latino people with a CVA (GLB-CVA Latino).

Aims:

1. : To create a modification of the CDC-recognized, evidence-based GLB-CVA to be culturally appropriate to meet the unique needs of people who identify as Hispanic/Latino, available in English and Spanish languages, using a Community-Based Participatory Research approach and AB of key stakeholders (patients, caregivers, clinicians, researchers).

2. : Conduct a single-arm trial to describe the effect of participation in the GLB-CVA Latino on primary and secondary outcomes for 24 individuals who identify as Hispanic/Latino (12 English speakers and 12 Spanish speakers) at 3, 6, and 12 months from baseline.

3. : Evaluate the participant compliance (feasibility) and fidelity (adherence to the DPP GLB content) with the GLB-CVA Latino intervention.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

GLB CVA Latino

The GLB program, adapted for Latino individuals with stroke, will be delivered to participants over a 12-month period, divided into 22 in-person or virtual, group sessions. The goal of the GLB program is to help the participant achieve and maintain a 5-7% weight-loss using a two-pronged approach:

1. Physical activity: This is based upon recommendations by the American Heart Association and the American College of Sports Medicine (ACSM) to achieve 150 minutes of moderate intensity activity each week. Walking is the primary activity recommended.

2. Healthy eating: Based on United States Department of Agriculture guidelines, the GLB emphasizes healthy eating patterns and tracking dietary intake. Key recommendations include individuals consuming (1) a variety of vegetables, (2) whole fruits, (3) whole grains, (4) fat-free or low-fat dairy, (5) a variety of lean proteins, and (6) oils at every meal

Group Type: EXPERIMENTAL

Group Lifestyle Balance

Intervention Type: BEHAVIORAL

The Group Lifestyle Balance (GLB) program is a self-management intervention that has been shown to result in weight-loss and reduce the risk for Type 2 diabetes through increased physical activity and healthy eating behaviors in the general population. The GLB is a direct adaptation of the Diabetes Prevention Program, both developed at the Diabetes Prevention and Support Center at the University of Pittsburgh. The GLB is designed for delivery in a group-based, community setting,4 and has resulted in weight-loss in a variety of settings, such as community centers, churches, worksites, and healthcare systems.

Interventions

Group Lifestyle Balance

The Group Lifestyle Balance (GLB) program is a self-management intervention that has been shown to result in weight-loss and reduce the risk for Type 2 diabetes through increased physical activity and healthy eating behaviors in the general population. The GLB is a direct adaptation of the Diabetes Prevention Program, both developed at the Diabetes Prevention and Support Center at the University of Pittsburgh. The GLB is designed for delivery in a group-based, community setting,4 and has resulted in weight-loss in a variety of settings, such as community centers, churches, worksites, and healthcare systems.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI ≥25
• Identify as Hispanic or Latino
• 18-85 years of age
• All types of stroke
• Medically able to participate in a weight-loss program
• Physical Activity Readiness Questionnaire +
• ≥12 months post first stroke

Exclusion Criteria

• Contraindications for physical activity
• Low Cognitive Function
• Residing in hospital, acute rehab, SNF
• Not fluent in English or Spanish
• Pre-existing eating disorder
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Librada Callender, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott and White Research Institute

Locations

Baylor Institute for Rehabilitation

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alvaro Carrera

Role: CONTACT

alvaro.carrera@bswhealth.org

469-831-5321

Facility Contacts

Alvaro Carrera

Role: primary

alvaro.carrera@bswhealth.org

4698315321

Other Identifiers

024-268

Identifier Type: -

Identifier Source: org_study_id