StrokeNCT06517459
Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
A study testing Group Lifestyle Balance in people with Stroke, run by Baylor Research Institute at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Group Lifestyle Balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications for physical activity
- Low Cognitive Function
- Residing in hospital, acute rehab, SNF
- Not fluent in English or Spanish
- Pre-existing eating disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor Institute for Rehabilitation
Dallas, Texas, 75246
Alvaro Carrera, 4698315321, alvaro.carrera@bswhealth.org
About this study
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
Read the 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:
- : 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).
- : 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.
- : Evaluate the participant compliance (feasibility) and fidelity (adherence to the DPP GLB content) with the GLB-CVA Latino intervention.
- Conditions
- Stroke
- Being tested
- Group Lifestyle Balance
- Keywords
- Weight-loss, Stroke, Group Lifestyle Balance, Dietary Behaviors, Physical Activity
- Medical subject headings
- Stroke, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Lifestyle BalanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Group Lifestyle Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Secondary outcomes (18)
HbA1c
Fasting venous sample will be obtained for hemoglobin a1c to assess average blood sugar level over the past 2-3 months. Fasting venous samples will also be collected for fasting blood glucose, HDL/LDL, total cholesterol, and triglyceride level. Coordinators are trained phlebotomists
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Fasting blood glucose
Fasting venous sample will be obtained for hemoglobin a1c to assess average blood sugar level over the past 2-3 months. Fasting venous samples will also be collected for fasting blood glucose, HDL/LDL, total cholesterol, and triglyceride level. Coordinators are trained phlebotomists
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Lipid panel
Fasting venous sample will be obtained for hemoglobin a1c to assess average blood sugar level over the past 2-3 months. Fasting venous samples will also be collected for fasting blood glucose, HDL/LDL, total cholesterol, and triglyceride level. Coordinators are trained phlebotomists
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Circumference
Waist circumference measured at the umbilicus and mid-upper arm circumference following ACSM guidelines.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Height
Will be collected using a stadiometer and used to calculate BMI
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Blood pressure
Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
8-year Diabetes Risk
The Framingham Heart Study diabetes risk score83 will be calculated using predictors including age, gender, fasting glucose, BMI, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials. The age range for this score is 45 years to 64 years, and therefore only individuals within this age will have calculated scores. Furthermore, the minimum cut-off score is 3.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
6 Minute Walk Test (6MWT)
Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
10 Meter Walk Test (10MWT)
Assesses walking speed in (m/s) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Behavioral Risk Factor Surveillance System (BRFSS)
The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Neighborhood Environment Walkability Scale (NEWS)
NEWS assesses participants' perception of neighborhood features related to physical activity and grocery shopping, including residential density, land use mix (including both indices of proximity and accessibility), street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Short Assessment of Health Literacy
Combined word recognition test and comprehension test using multiple-choice questions. Identifies individuals with low health literacy.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Self-Rated Abilities for Health Practice
Includes 28 items to assess health behaviors among people with disabilities and yields a total Health Practices Score plus 4 subscale scores (Exercise, Nutrition, Health Practices, and Psychological Well Being). Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher self-efficacy for the health behaviors.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Stroke Impact Scale - Quality of Life
Quality of life will be assessed using the Stroke Impact Scale, which assesses 8 dimensions of health-related quality of life specific to people post stroke including subscales (using a 5pt Likert scale) assessing strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand function, and participation/role function.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Change in Exit Survey
Participants will be asked to complete an exit survey at the 12-month assessment, asking about experience in, and satisfaction with, the GLB-CVA Latino (including satisfaction and feasibility with modifications and language translation) and suggestions for improvement.
Measured: [Time Frame: 12 months]
Brief Acculturation Scale for Hispanics
4 item language based measure of acculturation for Hispanic populations.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Social Support for Eating Habits
Questionnaire that assesses the frequency of support received from others for healthy eating habits over the past 3 months.
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Social Support for Physical Activity
Questionnaire that assesses the frequency of support received from others for engaging in physical activity over the past 3 months
Measured: [Time Frame: Baseline, 3, 6, and 12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start19 May 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be assigned to the modified GLB-CVA program, available in Spanish or English.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Librada Callender, PhD, MPH, Principal investigator, Baylor Scott & White The Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517459
- Sponsor's protocol ID
- 024-268
- Status last verified
- Oct 2025
- First submitted
- 18 Jul 2024
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
- ClinicalTrials.gov ID
- NCT06517459
- Acronym / sponsor ID
- 024-268
- Conditions
- Stroke
- Keywords
- Weight-loss, Stroke, Group Lifestyle Balance, Dietary Behaviors, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- : 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).
- : 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.
- : Evaluate the participant compliance (feasibility) and fidelity (adherence to the DPP GLB content) with the GLB-CVA Latino intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be assigned to the modified GLB-CVA program, available in Spanish or English.
| Arm | Type | Receives |
|---|---|---|
| GLB CVA Latino | Experimental | Behavioral: Group Lifestyle BalanceThe 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Contraindications for physical activity
- Low Cognitive Function
- Residing in hospital, acute rehab, SNF
- Not fluent in English or Spanish
- Pre-existing eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Lifestyle BalanceThe 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. | Behavioural | GLB CVA Latino |
Primary outcome
Change in weight
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
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.
18 secondary outcomes
HbA1c
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Fasting blood glucose
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Lipid panel
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Circumference
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Height
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Blood pressure
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
8-year Diabetes Risk
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
6 Minute Walk Test (6MWT)
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
10 Meter Walk Test (10MWT)
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Behavioral Risk Factor Surveillance System (BRFSS)
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Neighborhood Environment Walkability Scale (NEWS)
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Short Assessment of Health Literacy
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Self-Rated Abilities for Health Practice
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Stroke Impact Scale - Quality of Life
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Change in Exit Survey
Time frame: [Time Frame: 12 months]
Brief Acculturation Scale for Hispanics
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Social Support for Eating Habits
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Social Support for Physical Activity
Time frame: [Time Frame: Baseline, 3, 6, and 12 months]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Librada Callender, PhD, MPH principal investigator
Baylor Scott & White The Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Lifestyle Balance in people with Stroke, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Carrera (469-831-5321, alvaro.carrera@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: [Time Frame: Baseline, 3, 6, and 12 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.