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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke, Acute; Stroke, Cardiovascular; Stroke (CVA) or TIA; Stroke/Brain Attack
• Intervention / Treatment: Behavioral: Group Lifestyle Balance for People Post Stroke (GLB-CVA)

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75204
      • Recruiting
      • Baylor Scott & White Research Institute
      • Principal Investigator: Evan E McShan, PhD
      • Contact: Stephanie Calhoun, BS; Phone Number: 214.228.5181; Email: Stephanie.Calhoun1@BSWHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait List Control (WLC); 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.
Experimental: Telehealth Group LIfestyle Balance for People with Stroke (tGLB-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.	Behavioral: Group Lifestyle Balance for People Post Stroke (GLB-CVA); 12-month healthy lifestyle and weight loss program modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
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).	6, 12, 18 month

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Stroke; Myocardial Infarction
• Other Study ID Numbers: BSW IRB# 024-414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No