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

NCT06517459 | Recruiting

• 1 other identifier: 024-268
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

Weight-loss; Stroke; Group Lifestyle Balance; Dietary Behaviors; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Weight will be measured during in-person assessments at BSWIR using a Seca 664 scale. Height will be measured using a stadiometer. Weight and height will be used to calculate BMI. A BodyTrace Smart Scale will be provided to participants to facilitate self-weighing in the home, which include cellular connectivity at no cost to participants so weight will be sent directly to the research team.

  [Time Frame: Baseline, 3, 6, and 12 months]

Secondary Outcomes (18)

• HbA1c

  [Time Frame: Baseline, 3, 6, and 12 months]

• Fasting blood glucose

  [Time Frame: Baseline, 3, 6, and 12 months]

• Lipid panel

  [Time Frame: Baseline, 3, 6, and 12 months]

• Circumference

  [Time Frame: Baseline, 3, 6, and 12 months]

• Height

  [Time Frame: Baseline, 3, 6, and 12 months]

Study Arms (1)

GLB CVA Latino

EXPERIMENTAL

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

Behavioral: Group Lifestyle Balance

Interventions

Group Lifestyle Balance 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.

GLB CVA Latino

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥25
• Identify as Hispanic or Latino
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Institute for Rehabilitation

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Librada Callender, PhD, MPH

  Baylor Scott and White Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvaro Carrera

CONTACT

469-831-5321; alvaro.carrera@bswhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to the modified GLB-CVA program, available in Spanish or English.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: May 19, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (1)