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NCT Number: NCT06569121

Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA)

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

Location status: Recruiting

Location contact

Evan E McShan, PhD

PRINCIPAL_INVESTIGATOR

Stephanie Calhoun, BS

CONTACT

[email protected]

214.228.5181

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Group Lifestyle Balance for People Post Stroke (GLB-CVA)

Behavioral

12-month healthy lifestyle and weight loss program modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB)

Primary outcomes

  1. Body Weight

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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.

Secondary outcomes

  1. Circumference

    Time frame: Baseline, 3, 6, 9, 12, 18 month

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

  2. Height

    Time frame: Baseline, 3, 6, 9, 12, 18 month

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

  3. Body Mass Index (BMI)

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    Body Mass Index (BMI, kg/m^2) will be calculated from height and weight from a local Quest Diagnostics

  4. Blood pressure

    Time frame: Baseline, 3, 6, 9, 12, 18 month

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

  5. Blood Sugar, Hemoglobin A1c (HbA1c)

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    Fasting venous sample will be obtained for Hemoglobin A1c (HbA1c) at a local Quest Diagnostics and recorded as a parentage.

  6. Blood Glucose

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    Fasting venous sample will be obtained for blood glucose (mg/dL) at a local Quest Diagnostics.

  7. High Density Lipoprotein (HDL) cholesterol

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    Fasting venous sample will be obtained for High Density Lipoprotein (HDL, mg/dL) cholesterol at a local Quest Diagnostics

  8. Low Density Lipoprotein (LDL) cholesterol

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    Fasting venous sample will be obtained for Low Density Lipoprotein (LDL, mg/dL) cholesterol at a local Quest Diagnostics

  9. Fasting venous sample

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    Fasting venous sample will be obtained for triglyceride level (mg/dL) at a local Quest Diagnostics

  10. 8-year Diabetes Risk

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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

  11. Metabolic Syndrome Severity Score

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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.

  12. Behavioral Risk Factor Surveillance System (BRFSS)

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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.

  13. Substance Use

    Time frame: Baseline, 12, 18 month

    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.

  14. Neighborhood Environment Walkability Scale (NEWS)

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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.

  15. Quality of Life

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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.

  16. Self-Rated Abilities for Health Practice

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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.

  17. Social Support for Healthy Eating (SSEH)

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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.

  18. Social Support for Physical Activity (SSPA)

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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.

  19. Care Partner Healthy Lifestyle Support Tool

    Time frame: Baseline, 3, 6, 9, 12, 18 month

    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.

  20. Telehealth Usability and Satisfaction

    Time frame: 6, 12, 18 month

    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).

  21. Exit Survey & Interview

    Time frame: 12 or 18 month

    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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

Efficacy of an Evidence-based Telehealth-delivered Weight-loss Intervention to Enhance Access and Reach Underserved Groups After Stroke

Acronym: tGLB-CVA

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Aug 23, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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