Recruiting

Telehealth Delivered Group Lifestyle Balance

Sponsor:

Baylor Research Institute

Code:

NCT06569121

Conditions

Stroke, Acute

Stroke

Stroke, Cardiovascular

Stroke (CVA) or TIA

Stroke/Brain Attack

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Group Lifestyle Balance for People Post Stroke (GLB-CVA)

Study Details

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.

Conditions

Stroke, Acute

Stroke

Stroke, Cardiovascular

Stroke (CVA) or TIA

Stroke/Brain Attack

Study ID

NCT06569121

Start date

Dec 7, 2024

Status verified date

Jan, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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)

Primary outcome measure

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

Central Contacts and Locations

Locations

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75204

Contacts

Stephanie Calhoun, BS

214.228.5181Stephanie.Calhoun1@BSWHealth.org

Principal Investigator:

Evan E McShan, PhD

More Information

Sponsor

Baylor Research Institute

Last update posted

Jan 21, 2026

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-01-21.