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
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedStudy Start
First participant enrolled
December 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
January 21, 2026
January 1, 2025
2.7 years
August 20, 2024
January 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (21)
Circumference
Baseline, 3, 6, 9, 12, 18 month
Height
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 Sugar, Hemoglobin A1c (HbA1c)
Baseline, 3, 6, 9, 12, 18 month
- +16 more secondary outcomes
Study Arms (2)
Wait List Control (WLC)
NO INTERVENTIONParticipants 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)
EXPERIMENTALThe 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.
Interventions
12-month healthy lifestyle and weight loss program modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor Scott & White Research Institute
Dallas, Texas, 75204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 23, 2024
Study Start
December 7, 2024
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
January 21, 2026
Record last verified: 2025-01