Efficacy of an Evidence-based Telehealth-delivered Weight-loss Intervention to Enhance Access and Reach Underserved Groups After Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Body Weight
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
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.
Intervention: Group Lifestyle Balance for People Post Stroke (GLB-CVA) (Behavioral)
Outcomes
Primary Outcomes
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
- Circumference(Baseline, 3, 6, 9, 12, 18 month)
- Body Mass Index (BMI)(Baseline, 3, 6, 9, 12, 18 month)
- Blood pressure(Baseline, 3, 6, 9, 12, 18 month)
- Blood Glucose(Baseline, 3, 6, 9, 12, 18 month)
- 8-year Diabetes Risk(Baseline, 3, 6, 9, 12, 18 month)
- Self-Rated Abilities for Health Practice(Baseline, 3, 6, 9, 12, 18 month)
- Care Partner Healthy Lifestyle Support Tool(Baseline, 3, 6, 9, 12, 18 month)
- Exit Survey & Interview(12 or 18 month)
- Height(Baseline, 3, 6, 9, 12, 18 month)
- Blood Sugar, Hemoglobin A1c (HbA1c)(Baseline, 3, 6, 9, 12, 18 month)
- High Density Lipoprotein (HDL) cholesterol(Baseline, 3, 6, 9, 12, 18 month)
- Low Density Lipoprotein (LDL) cholesterol(Baseline, 3, 6, 9, 12, 18 month)
- Fasting venous sample(Baseline, 3, 6, 9, 12, 18 month)
- Metabolic Syndrome Severity Score(Baseline, 3, 6, 9, 12, 18 month)
- Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, 3, 6, 9, 12, 18 month)
- Substance Use(Baseline, 12, 18 month)
- Neighborhood Environment Walkability Scale (NEWS)(Baseline, 3, 6, 9, 12, 18 month)
- Social Support for Healthy Eating (SSEH)(Baseline, 3, 6, 9, 12, 18 month)
- Quality of Life(Baseline, 3, 6, 9, 12, 18 month)
- Social Support for Physical Activity (SSPA)(Baseline, 3, 6, 9, 12, 18 month)
- Telehealth Usability and Satisfaction(6, 12, 18 month)