Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA)
NCT Number: NCT06569121
Acronym: tGLB-CVA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Acute|Stroke|Stroke, Cardiovascular|Stroke (CVA) or TIA|Stroke/Brain Attack
Interventions: BEHAVIORAL: Group Lifestyle Balance for People Post Stroke (GLB-CVA)
Sponsor: Baylor Research Institute
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-12-31
Locations: Baylor Scott & White Research Institute, Dallas, Texas, 75204, United States

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.

Primary Outcome Measures: 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., Baseline, 3, 6, 9, 12, 18 month
Secondary Outcome Measures: Circumference, Waist and hip circumference (centimeters) will be collected from a local Quest Diagnostics, Baseline, 3, 6, 9, 12, 18 month|Height, Height (inches) will be collected from a local Quest Diagnostics, 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, Baseline, 3, 6, 9, 12, 18 month|Blood pressure, Blood Pressure (mmHg, diastolic and systolic) will be collected at a local Quest Diagnostics, 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., 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., 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, 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, 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, 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, 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., 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., 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., 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., 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., 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., 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., 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., 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., 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). 21 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)., 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, 12 or 18 month