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

NCT ID: NCT06569121

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-07

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

12-month healthy lifestyle and weight loss program modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB)

Interventions

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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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role collaborator

Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Baylor Scott & White Research Institute

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Stephanie Calhoun, BS

Role: primary

214.228.5181

Other Identifiers

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BSW IRB# 024-414

Identifier Type: -

Identifier Source: org_study_id

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