StrokeGLB-CVANCT03873467
Group Lifestyle Balance™ for Individuals With Stroke (GLB-CVA)
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 RCT is to examine the efficacy of the Group Lifestyle Balance (GLB) program adapted for people with stroke (CVA) on primary (weight) and secondary outcomes at 3, 6, 12 months from enrollment into the program. 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
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 30 Dec 2027
- 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
- 18 to 85 years of age
- BMI ≥25
- All types of stroke
- At least 12 months post first stroke
- Physician approval
Who cannot join
- Low cognition
- Not fluent in the English language
- Conditions for which physical activity is contraindicated
- Taking medication for type 2 diabetes
- Residing in a hospital, acute rehabilitation setting, or skilled nursing facility
- Pregnancy
- Pre-existing diagnosis of an eating disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, 75246
About this study
Official title: Efficacy of an Evidence-based Healthy Lifestyle Intervention for People Following CVA
The purpose of this RCT is to examine the efficacy of the Group Lifestyle Balance (GLB) program adapted for people with stroke (CVA) on primary (weight) and secondary outcomes at 3, 6, 12 months from enrollment into the program.
Read the detailed description
Weight gain greatly increases the risk of chronic diseases after stroke such as diabetes, metabolic syndrome, pulmonary and heart disease. Approaches to weight-loss are lacking, yet necessary, due to the unique physiological and cognitive needs of persons with CVA. There is evidence that interventions that improve physical activity and healthy eating behaviors concurrently offer greatest potential for weight-loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight-loss program that has been used extensively with the general population, but not with people after CVA. Investigators modified the program to meet the needs of people post stroke (GLB-CVA).
Study Aims:
The study consists of five specific aims.
Specific Aim 1: To create an appropriate adaptation of the DPP-GLB program that meets the unique needs of people post CVA (GLB-CVA) using a Community-Based Participatory Research approach and Advisory Board of key stakeholders (patients, caregivers, clinicians, researchers).
Specific Aim 2: To establish the feasibility of delivering the GLB-CVA intervention.
Specific Aim 3: Conduct a randomized controlled trial (RCT) to examine the effectiveness of the GLB-CVA on primary and secondary outcomes in the intervention group compared to the wait-list control group at 3, 6, and 12 months from baseline.
Specific Aim 4: Describe the effect of the GLB-CVA on metabolic biomarkers in the experimental group compared to the wait-list control group at baseline, 3, and 6 months.
Specific Aim 5: Describe the association between biomarkers of neurodegeneration and physiologic, functional, and patient reported outcomes at baseline, 3, and 6 months.
- Conditions
- Stroke
- Being tested
- Group Lifestyle Balance, Usual Care
- Keywords
- Group Lifestyle Balance, Physical Activity, Stroke, Weight-loss, Dietary Behaviors
- Medical subject headings
- Stroke, Motor Activity, Weight Loss
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, and has resulted in weight-loss in a variety of settings, such as community centers, churches, worksites, and healthcare systems. The GLB curriculum used in this study has been adapted for people with stroke.
Usual CareOther
Participants randomized to the wait-list control group will receive usual care for 6 months before beginning the modified GLB program.
| Study group | Role | What they receive |
|---|---|---|
| GLB Weight-Loss Intervention | Experimental | The GLB program, adapted for individuals with stroke, will be delivered to participants over a 12-month period, divided into 22 in-person or virtual, group sessions. The intervention promotes 5-7% weight-loss by reducing calories and increasing exercise (150 minutes of moderate physical activity per week). Receives: Behavioral: Group Lifestyle Balance |
| Wait-List Control | Other | The wait-list control group will receive no intervention for 6 months after enrollment. After the 6 month control period, the wait-list control group will receive the GLB Intervention. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g., walker; wheelchair).
Measured: Baseline, 3, 6, 12 months
Secondary outcomes (29)
Physical Activity
Accelerometers will be worn by participants for two weeks around each study visit to objectively track physical activity participation (amount and intensity). Participants will be given the Actigraph accelerometer at the beginning of the study and will be provided with verbal and written instructions.
Measured: Baseline, 3, 6, 12 months
Arm Circumference
Arm circumference measured at mid-upper arm following ACSM guidelines. A total of three measurements will be taken and an average of the three will be used. Measurements will be taken in centimeters.
Measured: Baseline, 3, 6, 12 months
Blood Pressure
Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded
Measured: Baseline, 3, 6, 12 months
Cholesterol
Fasting venous sample will be obtained. Coordinators are trained phlebotomists.
Measured: Baseline, 3, 6, 12 months
Risk of Diabetes
The Framingham Heart Study diabetes risk score 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. Risk score calculator and regression model are free and used in GLB weight-loss studies. Each risk predictor is assigned points ranging from 2-10. Risk factors are combined and a total score is calculated, with higher scores designating greater 8-year risk.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: Baseline, 3, 6, 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: Baseline, 3, 6, 12 months
6 Minute Walk Test (6MWT)
Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity. Endurance is essential to participate in community-based activities.
Measured: Baseline, 3, 6, 12 months
Perceived Social Support
The Multidimensional Scale of Perceived Social Support (MSPSS) is comprised of 12 questions with a 4-item subscale. The MSPSS is designed to assess perception of social support from friends, family, and significant others
Measured: Baseline and 12 months
Self-reported activities of health using the Self-Rated Abilities for Health Practice scale
Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices score plus 4 subscales scores regarding 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 exercise self-efficacy.
Measured: Baseline and 12 months
Neighborhood walkability using Walk Score®
Walk Score® is publicly available and measures the walkability of any address using a patented system. For each address, Walk Score ® analyzes hundreds of walking routes to nearby amenities and awards points based on distance to each amenity. Walk Score® also measures pedestrian friendliness by analyzing population density and road metrics such a block length and intersection density. Scores are given on a scale of 0 to 100.
Measured: Baseline
Resting Metabolic Rate
MedGem® is an FDA cleared and validated indirect calorimetry device. It is handheld and measures oxygen consumption (V02) to determine resting metabolic rate (RMR).
Measured: Baseline
Behavioral Risk Factor Surveillance
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: Baseline, 3, 6, 12 months
Participant quality of ife
Quality of life will be assess using the stroke impact scale (SIS), which assesses 8 dimensions of health-related QOL specific to people post CVA 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: Baseline, 6, 12 months
Stressful Life Events using the Holmes and Rahe Stress Inventory
This inventory consists of 40 life events and asks the participant to recall if any of the events happened within the previous year (e.g., death of spouse; personal illness; change in sleep). Endorsement of these events are totaled and higher scores indicate a greater amount of stressful life events. Point values for the Holmes and Rahe Stress Inventory were weighted and summed for each individual based on scoring instructions. Individuals who scored 150 points or less were categorized as low susceptibility to a health breakdown in the next two years, 151-300 points were 50% chance of health breakdown, and 301 points or more were 80% chance of health breakdown.
Measured: Baseline and 12 months
Executive Function and Cognition using the Montreal Cognitive Assessment
The MOCA is a brief, 8-section assessment of various cognitive domains including executive function, memory, language, attention, concentration, orientation, and working memory in neurologic populations.Each item on the MOCA is allocated a set of points adding up to 30.
Measured: Baseline, 3, and 12 months
Habit Formation
The self-reported habit index (SRHI) measures the self-reported perceptions of habit strength for an identified behavior. It consists of 12 items for each selected behavior and uses a 7-point Likert scale from "completely disagree" to "completely agree." Higher totals represent greater perception of habit strength. The SRHI showed high reliability across four studies with alphas of .89, .92, .89, .94, .95, .94, and .85.
Measured: Baseline, 3, and 12 months
Stroke Severity
The Modified Rankin Scale (MRS) measures the degree of disability or dependence for daily activities of people who have had a stroke. The MRS is an ordinal scale with six categories ranging from zero (no symptoms) to five (complete physical dependence). A score of six signifies death.
Measured: Baseline
Pain Interference
The Pain Interference-Short Form is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This measure is used to assess adult self-reported consequences of pain and pain consequences (e.g. interference in social, cognitive, emotional, physical and recreational activities). This measure consists of four questions with five response option ranging from one to five. The sum of all responses creates a total raw score. This measure is normed to the US general population.
Measured: Baseline, 3, 6, and 12 months
Sleep Disturbance
The Sleep Disturbance-Short Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS) and used to assess adult sleep disturbance profiles. This measure has four questions, each with five response options ranging in value from one to five. The sum of each response creates a total raw score. The measure is normed to the US general population.
Measured: Baseline, 3, 6, 12 months
Waist Circumference
Waist circumference will be measured at the umbilicus following ACSM guidelines. A total of three measurements will be taken and an average of the three will be the final measurement used. Measurements will be scored in centimeters.
Measured: Baseline, 3, 6, and 12 months
HbA1c
Fasting venous sample will be obtained for hemoglobin a1c to assess average blood sugar level over the past 2-3 months. Coordinators are trained phlebotomists.
Measured: Baseline, 3, 6, and 12 months
Triglycerides
Fasting venous sample will be obtained. Coordinators are trained phlebotomists.
Measured: Baseline, 3, 6, 12 months
Blood Glucose
Fasting venous sample will be obtained. Coordinators are trained phlebotomists.
Measured: Baseline, 3, 6, 12 months
Biomarker Analysis
Isrin, Angiogenic factors (VEGF), Total Homocysteine, Lipoprotein-associated phospholipase A2 (Lp-PLA2), ICF-1, Brain derived neurotrophic factor (BDNF), and Tau proteins (total and phosphorylated) will be drawn to assess relationships with outcome variables.
Measured: Baseline, 3, and 6 months
Stages of Change
A modified version of Prochaska and DiClemente's Stages of Change model will be administered to measure readiness for behavior change. The measure consists of two behaviors (eating and exercise) with five questions each related to a stage of change (precontemplation, contemplation, preparation, action, maintenance).
Measured: Baseline, 3, 6, and 12 months
Metabolic Score Calculator (MetS)
The metabolic score calculator will be used at all time points to determine the risk for metabolic syndrome. The following variables will be used to determine metabolic risk using the free metabolic risk calculator: gender, race and ethnicity, systolic blood pressure, fasting glucose, triglycerides, high-density lipoprotein (HDL), weight, height, and waist circumference. Scores are calculated are standardized to the general population.
Measured: Baseline, 3, 6, and 12 months
CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form
This self-report survey was developed by the National Institute of Mental Health. The full survey consists of 64 questions with an open-ended section at the end to elicit concerns and feedback related to the effects of COVID-19. For this current study, however, only sections on Exposure Status (10 items), Life Changes (15 items), and Emotions/Worries (7 items), and the open-ended question will be asked. Questions are asked "over the past two weeks."
Measured: Up to 12 months
PROMIS Social Isolation Short Form 4a
The Social Isolation Short-Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This form assesses the perceptions of being "avoided, excluded, detached, disconnected from, or unknown by, others. There is no timeframe for the form. The measure is normed to the US population.
Measured: Up to 12 months
Media Questionnaire
To assess media exposure and fear of media exposure during COVID-19 we have added 6 questions. These are asked "over the past two weeks." These questions address time spent watching the television, listening to radio, reading the newspaper, and searching the internet and social media. In addition, a 6th question related to fear is asked using a 5-point Likert scale.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start8 Jul 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (RCT). Participants will be randomized into one of two groups: (1) the GLB Intervention Group and (2) the wait-list controlled group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Simon J Driver, PhD, Principal investigator, Baylor Scott & White Institute for Rehabilitation (BSWIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873467
- Sponsor's protocol ID
- BSWRI 018-714
- Acronym
- GLB-CVA
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Driver S, McShan E, Swank C, Grobe K, Calhoun S, Bailey R, Kramer K. Creating an appropriate adaptation of a healthy lifestyle intervention for people after stroke. Brain Inj. 2020 Sep 18;34(11):1497-1503. doi: 10.1080/02699052.2020.1808703. Epub 2020 Aug 19.
PubMed 32813569Driver S, Swank C, Froehlich-Grobe K, McShan E, Calhoun S, Bennett M. Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Oct 18;8(10):e14338. doi: 10.2196/14338.
PubMed 31628790
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Evidence-based Healthy Lifestyle Intervention for People Following CVA
- ClinicalTrials.gov ID
- NCT03873467
- Acronym / sponsor ID
- GLB-CVA / BSWRI 018-714
- Conditions
- Stroke
- Keywords
- Group Lifestyle Balance, Physical Activity, Stroke, Weight-loss, Dietary Behaviors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Mar 2019 (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 RCT is to examine the efficacy of the Group Lifestyle Balance (GLB) program adapted for people with stroke (CVA) on primary (weight) and secondary outcomes at 3, 6, 12 months from enrollment into the program.
Detailed description
Weight gain greatly increases the risk of chronic diseases after stroke such as diabetes, metabolic syndrome, pulmonary and heart disease. Approaches to weight-loss are lacking, yet necessary, due to the unique physiological and cognitive needs of persons with CVA. There is evidence that interventions that improve physical activity and healthy eating behaviors concurrently offer greatest potential for weight-loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight-loss program that has been used extensively with the general population, but not with people after CVA. Investigators modified the program to meet the needs of people post stroke (GLB-CVA).
Study Aims:
The study consists of five specific aims.
Specific Aim 1: To create an appropriate adaptation of the DPP-GLB program that meets the unique needs of people post CVA (GLB-CVA) using a Community-Based Participatory Research approach and Advisory Board of key stakeholders (patients, caregivers, clinicians, researchers).
Specific Aim 2: To establish the feasibility of delivering the GLB-CVA intervention.
Specific Aim 3: Conduct a randomized controlled trial (RCT) to examine the effectiveness of the GLB-CVA on primary and secondary outcomes in the intervention group compared to the wait-list control group at 3, 6, and 12 months from baseline.
Specific Aim 4: Describe the effect of the GLB-CVA on metabolic biomarkers in the experimental group compared to the wait-list control group at baseline, 3, and 6 months.
Specific Aim 5: Describe the association between biomarkers of neurodegeneration and physiologic, functional, and patient reported outcomes at baseline, 3, and 6 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (RCT). Participants will be randomized into one of two groups: (1) the GLB Intervention Group and (2) the wait-list controlled group.
| Arm | Type | Receives |
|---|---|---|
| GLB Weight-Loss Intervention | Experimental | Behavioral: Group Lifestyle BalanceThe GLB program, adapted for individuals with stroke, will be delivered to participants over a 12-month period, divided into 22 in-person or virtual, group sessions. The intervention promotes 5-7% weight-loss by reducing calories and increasing exercise (150 minutes of moderate physical activity per week). |
| Wait-List Control | Other | Other: Usual CareThe wait-list control group will receive no intervention for 6 months after enrollment. After the 6 month control period, the wait-list control group will receive the GLB Intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 85 years of age
- BMI ≥25
- All types of stroke
- At least 12 months post first stroke
- Physician approval
Key exclusion criteria (7 listed)
- Low cognition
- Not fluent in the English language
- Conditions for which physical activity is contraindicated
- Taking medication for type 2 diabetes
- Residing in a hospital, acute rehabilitation setting, or skilled nursing facility
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, and has resulted in weight-loss in a variety of settings, such as community centers, churches, worksites, and healthcare systems. The GLB curriculum used in this study has been adapted for people with stroke. | Behavioural | GLB Weight-Loss Intervention |
| Usual CareParticipants randomized to the wait-list control group will receive usual care for 6 months before beginning the modified GLB program. | Other | Wait-List Control |
Primary outcome
Change in weight
Time frame: Baseline, 3, 6, 12 months
Will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g., walker; wheelchair).
29 secondary outcomes
Physical Activity
Time frame: Baseline, 3, 6, 12 months
Arm Circumference
Time frame: Baseline, 3, 6, 12 months
Blood Pressure
Time frame: Baseline, 3, 6, 12 months
Cholesterol
Time frame: Baseline, 3, 6, 12 months
Risk of Diabetes
Time frame: Baseline, 3, 6, 12 months
10 Meter Walk Test (10MWT)
Time frame: Baseline, 3, 6, 12 months
6 Minute Walk Test (6MWT)
Time frame: Baseline, 3, 6, 12 months
Perceived Social Support
Time frame: Baseline and 12 months
Self-reported activities of health using the Self-Rated Abilities for Health Practice scale
Time frame: Baseline and 12 months
Neighborhood walkability using Walk Score®
Time frame: Baseline
Resting Metabolic Rate
Time frame: Baseline
Behavioral Risk Factor Surveillance
Time frame: Baseline, 3, 6, 12 months
Participant quality of ife
Time frame: Baseline, 6, 12 months
Stressful Life Events using the Holmes and Rahe Stress Inventory
Time frame: Baseline and 12 months
Executive Function and Cognition using the Montreal Cognitive Assessment
Time frame: Baseline, 3, and 12 months
Habit Formation
Time frame: Baseline, 3, and 12 months
Stroke Severity
Time frame: Baseline
Pain Interference
Time frame: Baseline, 3, 6, and 12 months
Sleep Disturbance
Time frame: Baseline, 3, 6, 12 months
Waist Circumference
Time frame: Baseline, 3, 6, and 12 months
HbA1c
Time frame: Baseline, 3, 6, and 12 months
Triglycerides
Time frame: Baseline, 3, 6, 12 months
Blood Glucose
Time frame: Baseline, 3, 6, 12 months
Biomarker Analysis
Time frame: Baseline, 3, and 6 months
Stages of Change
Time frame: Baseline, 3, 6, and 12 months
Metabolic Score Calculator (MetS)
Time frame: Baseline, 3, 6, and 12 months
CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form
Time frame: Up to 12 months
PROMIS Social Isolation Short Form 4a
Time frame: Up to 12 months
Media Questionnaire
Time frame: Up to 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 16 Oct 2026.
- Background: PubMed 32813569Driver S, McShan E, Swank C, Grobe K, Calhoun S, Bailey R, Kramer K. Creating an appropriate adaptation of a healthy lifestyle intervention for people after stroke. Brain Inj. 2020 Sep 18;34(11):1497-1503. doi: 10.1080/02699052.2020.1808703. Epub 2020 Aug 19.
- Background: PubMed 31628790Driver S, Swank C, Froehlich-Grobe K, McShan E, Calhoun S, Bennett M. Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Oct 18;8(10):e14338. doi: 10.2196/14338.
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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. This study is not recruiting at the moment.
Simon J Driver, PhD principal investigator
Baylor Scott & White Institute for Rehabilitation (BSWIR)
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Baseline, 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03873467, which also lists 2 linked publications.
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 16 Oct 2026.