Stroke, AcutetGLB-CVANCT06569121
Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA)
A study testing Group Lifestyle Balance for People Post Stroke (GLB-CVA) in people with Stroke, Acute and Stroke, run by Baylor Research Institute at 1 site in United States.
Trial summary
Investigators will conduct a randomized controlled trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-CVA (tGLB-CVA) compared to a 6-month wait-list control (WLC) in partnership with a diverse group of patient partners and peer mentors. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Acute, Stroke, Stroke, Cardiovascular
- What is being tested?
- Group Lifestyle Balance for People Post Stroke (GLB-CVA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2024to 31 Dec 2029
- Phase
- Interventional
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
- Body Mass Index ≥25
- All types of stroke
- Able to Participate in Physical Activity
- ≥12 months post first stroke
- Have internet, phone, or computer access, or be willing to use one provided by the study team
Who cannot join
- Contraindications for physical activity
- Low Cognitive Function
- Residing in hospital, acute rehab, skilled nursing facility
- Not fluent in the English language
- 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 Scott & White Research Institute
Dallas, Texas, 75204
Stephanie Calhoun, BS, 214-228-5181, Stephanie.Calhoun1@BSWHealth.org
Evan E McShan, PhD
About this study
Official title: Efficacy of an Evidence-based Telehealth-delivered Weight-loss Intervention to Enhance Access and Reach Underserved Groups After Stroke
Investigators will conduct a randomized controlled trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-CVA (tGLB-CVA) compared to a 6-month wait-list control (WLC) in partnership with a diverse group of patient partners and peer mentors.
- Being tested
- Group Lifestyle Balance for People Post Stroke (GLB-CVA)
- Medical subject headings
- Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Lifestyle Balance for People Post Stroke (GLB-CVA)Behavioural
12-month healthy lifestyle and weight loss program modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB)
| Study group | Role | What they receive |
|---|---|---|
| Wait List Control (WLC) | No intervention | Participants randomized to the wait list control (WLC) will begin the telehealth Group Lifestyle Balance for People post stroke (tGLB-CVA) intervention 6 months after enrolling into the study and completing a baseline assessment. |
| Telehealth Group LIfestyle Balance for People with Stroke (tGLB-CVA) | Experimental | The telehealth Group Lifestyle Balance for People post stroke (tGLB-CVA) is a one-year program with 22 sessions. The tGLB-CVA is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) developed by the University of Pittsburgh Diabetes Prevention Support Center (DPSC). It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The goal of the tGLB-CVA program is to help the participant achieve and maintain a 5-7% weight-loss through healthy eating and physical activity. Receives: Behavioral: Group Lifestyle Balance for People Post Stroke (GLB-CVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight (lbs) will be captured via self-weighing using provided BodyTrace Smart Scale, which includes cellular connectivity so weight will be sent directly to the research team. The scales have demonstrated good concordance rates with self-weighing in previous research. Scales will be setup by the research team before being mailed to participants with instructions.
Measured: Baseline, 3, 6, 9, 12, 18 month
Secondary outcomes (21)
Circumference
Waist and hip circumference (centimeters) will be collected from a local Quest Diagnostics
Measured: Baseline, 3, 6, 9, 12, 18 month
Height
Height (inches) will be collected from a local Quest Diagnostics
Measured: Baseline, 3, 6, 9, 12, 18 month
Body Mass Index (BMI)
Body Mass Index (BMI, kg/m^2) will be calculated from height and weight from a local Quest Diagnostics
Measured: Baseline, 3, 6, 9, 12, 18 month
Blood pressure
Blood Pressure (mmHg, diastolic and systolic) will be collected at a local Quest Diagnostics
Measured: Baseline, 3, 6, 9, 12, 18 month
Blood Sugar, Hemoglobin A1c (HbA1c)
Fasting venous sample will be obtained for Hemoglobin A1c (HbA1c) at a local Quest Diagnostics and recorded as a parentage.
Measured: Baseline, 3, 6, 9, 12, 18 month
Blood Glucose
Fasting venous sample will be obtained for blood glucose (mg/dL) at a local Quest Diagnostics.
Measured: Baseline, 3, 6, 9, 12, 18 month
High Density Lipoprotein (HDL) cholesterol
Fasting venous sample will be obtained for High Density Lipoprotein (HDL, mg/dL) cholesterol at a local Quest Diagnostics
Measured: Baseline, 3, 6, 9, 12, 18 month
Low Density Lipoprotein (LDL) cholesterol
Fasting venous sample will be obtained for Low Density Lipoprotein (LDL, mg/dL) cholesterol at a local Quest Diagnostics
Measured: Baseline, 3, 6, 9, 12, 18 month
Fasting venous sample
Fasting venous sample will be obtained for triglyceride level (mg/dL) at a local Quest Diagnostics
Measured: Baseline, 3, 6, 9, 12, 18 month
8-year Diabetes Risk
The Framingham Heart Study diabetes risk score will be calculated by combining age, gender, fasting glucose, body mass index, HDL cholesterol and triglyceride levels, blood pressure, and parental history of diabetes. Risk score calculator and regression model are free and used in GLB weight-loss trials
Measured: Baseline, 3, 6, 9, 12, 18 month
Metabolic Syndrome Severity Score
Metabolic Syndrome is a cluster of cardiovascular risk factors that include large waist circumference, high body mass index [BMI]), high blood pressure, high triglycerides, low high density lipoprotein (HDL) cholesterol and high fasting blood sugar (HBA1c). The score is calculated by combining these risk factors into a calculator. Individuals who have ≥3 of these risk factors have metabolic syndrome, placing them at greater risk of developing heart disease and diabetes. Risk scores below 0 indicate a lower degree of metabolic syndrome risk than the average US adult; scores above 0 are associated with greater risk for disease. A score of 1 indicates risk is higher than 84.1% of US adults and a score of 2 is higher than 97.7% of US adults. Z scores are calculated for BMI and waist circumference.
Measured: Baseline, 3, 6, 9, 12, 18 month
Behavioral Risk Factor Surveillance System (BRFSS)
The Behavioral Risk Factor Surveillance System (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. Investigators will use 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, 9, 12, 18 month
Substance Use
Substance use will be assessed using a brief survey of tobacco use (cigarettes, chewing tobacco), drug use (illicit or non-prescription drugs), and alcohol use.
Measured: Baseline, 12, 18 month
Neighborhood Environment Walkability Scale (NEWS)
Neighborhood Environment Walkability Scale (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. Scores provide insight into environmental barriers faced, are sensitive to behavior change, and can be used as a covariate for weight-loss. Scores are calculated in time to walk to local amenities (minutes) as well as Likert Scale from 1 (strongly disagree) to 4 (strongly agree) to ease of access to local amenities. Higher scores on the Likert Scale and lower scores in time suggest greater walkability.
Measured: Baseline, 3, 6, 9, 12, 18 month
Quality of Life
Quality of life (QOL) will be assessed using the Stroke Impact Scale (SIS), 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. Higher scores represent greater quality of life.
Measured: Baseline, 3, 6, 9, 12, 18 month
Self-Rated Abilities for Health Practice
Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices Score plus 4 subscale 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, 3, 6, 9, 12, 18 month
Social Support for Healthy Eating (SSEH)
The Social Support for Healthy Eating (SSEH) scale is a 10-item self-report questionnaire assessing the frequency of support received from others for healthy eating habits over the past 3 months on scale from 1 (none) to 5 (very often). It is comprised of a five-item Encouragement and a five-item Discouragement subscale. Family and friend support is measured separately. Higher scores represent greater support.
Measured: Baseline, 3, 6, 9, 12, 18 month
Social Support for Physical Activity (SSPA)
The Social Support for Physical Activity (SSPA) scale is a 13-item self-report questionnaire assessing the frequency of support received from others for engaging in physical activity over the past 3 months on scale from 1 (none) to 5 (very often). It is comprised of a 10-item Participation and a three-item Rewards and Punishments subscale. Family and friend support is measured separately.
Measured: Baseline, 3, 6, 9, 12, 18 month
Care Partner Healthy Lifestyle Support Tool
The Care Partner Healthy Lifestyle Support Tool was designed by researchers at BSWRI to measure how much care partner support was provided to participants during the healthy lifestyle intervention. Questions use a 4-point Likert Scale from "never" to "always", with higher scores representing higher support.
Measured: Baseline, 3, 6, 9, 12, 18 month
Telehealth Usability and Satisfaction
The Telehealth Usability and Satisfaction Scale is a validated assessment that measures 5 usability factors of telehealth (usefulness, ease of use, effectiveness, reliability, and satisfaction). 9 items are scored on level of agreement from 1-7, with higher scores indicating greater agreement. All subscales have good to excellent reliability (α=.79-.92).
Measured: 6, 12, 18 month
Exit Survey & Interview
Participants will be asked to complete Exit Survey and Focus Group at the 12 or 18-month assessment to provide experience in, and satisfaction with, the telehealth Group Lifestyle Balance for people post stroke (tGLB-CVA) intervention and suggestions for improvement. The focus group questions will focus on their experience, barriers and facilitators to behavior change, and engagement in the program
Measured: 12 or 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start7 Dec 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569121
- Sponsor's protocol ID
- BSW IRB# 024-414
- Acronym
- tGLB-CVA
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided