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Recruiting NCT06569121

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

No phase Interventional Stroke, Acute Stroke Stroke, Cardiovascular Stroke (CVA) or TIA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group Lifestyle Balance for People Post Stroke (GLB-CVA).
Who it may be relevant to
Registry conditions: Stroke, Acute, Stroke, Stroke, Cardiovascular, Stroke (CVA) or TIA. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of an Evidence-based Telehealth-delivered Weight-loss Intervention to Enhance Access and Reach Underserved Groups After Stroke

Overview

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.

Interventions

  • Behavioral 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 measures

  • Body Weight [Time frame: Baseline, 3, 6, 9, 12, 18 month]
Secondary outcome measures (12)
  • Circumference [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • Height [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • Body Mass Index (BMI) [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • Blood pressure [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • Blood Sugar, Hemoglobin A1c (HbA1c) [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • Blood Glucose [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • High Density Lipoprotein (HDL) cholesterol [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • Low Density Lipoprotein (LDL) cholesterol [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • Fasting venous sample [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • 8-year Diabetes Risk [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • Metabolic Syndrome Severity Score [Time frame: Baseline, 3, 6, 9, 12, 18 month]
  • Behavioral Risk Factor Surveillance System (BRFSS) [Time frame: Baseline, 3, 6, 9, 12, 18 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Baylor Scott & White Research Institute — Dallas

Identifiers

NCT: NCT06569121 · BSW IRB# 024-414

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗