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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT06569121
Status
Recruiting
Apply to this trial

Conditions

  • Stroke
  • Stroke (CVA) or TIA
  • Stroke, Acute
  • Stroke, Cardiovascular
  • Stroke/Brain Attack

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Group Lifestyle Balance for People Post Stroke (GLB-CVA) — BEHAVIORAL
    12-month healthy lifestyle and weight loss program modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB)

Study Details

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.

Key Dates

Start date
Dec 7, 2024
Status verified
Jan 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Body Weight [ Time Frame: Baseline, 3, 6, 9, 12, 18 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Scott & White Research InstituteDallasTexas75204
Stephanie Calhoun, BS
[email protected]
214.228.5181
Evan E McShan, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Baylor Scott & White Research Institute· Dallas, TX

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