Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA)
- Conditions
- Stroke (CVA) or TIAStroke, CardiovascularStroke/Brain AttackStroke, AcuteStroke
- Interventions
- Behavioral: Group Lifestyle Balance for People Post Stroke (GLB-CVA)
- Registration Number
- NCT06569121
- Lead Sponsor
- Baylor Research Institute
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 94
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telehealth Group LIfestyle Balance for People with Stroke (tGLB-CVA) Group Lifestyle Balance for People Post Stroke (GLB-CVA) 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.
- Primary Outcome Measures
Name Time Method Body Weight 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 Outcome Measures
Name Time Method Circumference Baseline, 3, 6, 9, 12, 18 month Waist and hip circumference (centimeters) will be collected from a local Quest Diagnostics
Height Baseline, 3, 6, 9, 12, 18 month Height (inches) will be collected from a local Quest Diagnostics
Body Mass Index (BMI) 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
Blood pressure Baseline, 3, 6, 9, 12, 18 month Blood Pressure (mmHg, diastolic and systolic) will be collected at a local Quest Diagnostics
Blood Sugar, Hemoglobin A1c (HbA1c) 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.
High Density Lipoprotein (HDL) cholesterol 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
Blood Glucose Baseline, 3, 6, 9, 12, 18 month Fasting venous sample will be obtained for blood glucose (mg/dL) at a local Quest Diagnostics.
Low Density Lipoprotein (LDL) cholesterol 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
Fasting venous sample Baseline, 3, 6, 9, 12, 18 month Fasting venous sample will be obtained for triglyceride level (mg/dL) at a local Quest Diagnostics
8-year Diabetes Risk 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
Metabolic Syndrome Severity Score 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.
Behavioral Risk Factor Surveillance System (BRFSS) 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.
Substance Use 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.
Neighborhood Environment Walkability Scale (NEWS) 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.
Social Support for Healthy Eating (SSEH) 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.
Quality of Life 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.
Self-Rated Abilities for Health Practice 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.
Social Support for Physical Activity (SSPA) 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.
Care Partner Healthy Lifestyle Support Tool 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.
Telehealth Usability and Satisfaction 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).
Exit Survey & Interview 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
Trial Locations
- Locations (1)
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States