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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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)
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
  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204

    Stephanie Calhoun, BS, 214-228-5181, Stephanie.Calhoun1@BSWHealth.org

    Evan E McShan, PhD

    Recruiting

Other trials in United States

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 groups in NCT06569121
Study groupRoleWhat they receive
Wait List Control (WLC)No interventionParticipants 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)ExperimentalThe 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.

  1. 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)
  1. Circumference

    Waist and hip circumference (centimeters) will be collected from a local Quest Diagnostics

    Measured: Baseline, 3, 6, 9, 12, 18 month

  2. Height

    Height (inches) will be collected from a local Quest Diagnostics

    Measured: Baseline, 3, 6, 9, 12, 18 month

  3. 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

  4. Blood pressure

    Blood Pressure (mmHg, diastolic and systolic) will be collected at a local Quest Diagnostics

    Measured: Baseline, 3, 6, 9, 12, 18 month

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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.

  1. First posted23 Aug 2024
  2. Study start7 Dec 2024
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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)
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

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