Clinical trial NCT06569121: Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA)
Official title: Efficacy of an Evidence-based Telehealth-delivered Weight-loss Intervention to Enhance Access and Reach Underserved Groups After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Stroke
Stroke, Cardiovascular
Stroke (CVA) or TIA
Stroke/Brain Attack
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2024-08-23
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Body Weight
timeFrame: Baseline, 3, 6, 9, 12, 18 month
Secondary outcomes:
measure: Circumference
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Height
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Body Mass Index (BMI)
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Blood pressure
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Blood Sugar, Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Blood Glucose
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: High Density Lipoprotein (HDL) cholesterol
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Low Density Lipoprotein (LDL) cholesterol
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Fasting venous sample
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: 8-year Diabetes Risk
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Metabolic Syndrome Severity Score
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Behavioral Risk Factor Surveillance System (BRFSS)
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Substance Use
timeFrame: Baseline, 12, 18 month
measure: Neighborhood Environment Walkability Scale (NEWS)
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Quality of Life
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Self-Rated Abilities for Health Practice
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Social Support for Healthy Eating (SSEH)
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Social Support for Physical Activity (SSPA)
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Care Partner Healthy Lifestyle Support Tool
timeFrame: Baseline, 3, 6, 9, 12, 18 month
measure: Telehealth Usability and Satisfaction
timeFrame: 6, 12, 18 month
measure: Exit Survey & Interview
timeFrame: 12 or 18 month
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
Study officials:
References: