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

Baylor Research Institute1 site in 1 country94 target enrollmentDecember 7, 2024

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

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stroke, Acute
Sponsor: Baylor Research Institute
Enrollment: 94
Locations: 1
Primary Endpoint: Body Weight
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 7, 2024

End Date

December 31, 2029

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baylor Research Institute

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Body Weight

Time Frame: Baseline, 3, 6, 9, 12, 18 month

Body weight (lbs) will be captured via self-weighing using provided BodyTrace Smart Scale, which includes cellular connectivity so weight will be sent directly to the research team. The scales have demonstrated good concordance rates with self-weighing in previous research. Scales will be setup by the research team before being mailed to participants with instructions.

Secondary Outcomes

Blood Glucose(Baseline, 3, 6, 9, 12, 18 month)
Circumference(Baseline, 3, 6, 9, 12, 18 month)
Height(Baseline, 3, 6, 9, 12, 18 month)
Body Mass Index (BMI)(Baseline, 3, 6, 9, 12, 18 month)
Blood pressure(Baseline, 3, 6, 9, 12, 18 month)
Blood Sugar, Hemoglobin A1c (HbA1c)(Baseline, 3, 6, 9, 12, 18 month)
High Density Lipoprotein (HDL) cholesterol(Baseline, 3, 6, 9, 12, 18 month)
Low Density Lipoprotein (LDL) cholesterol(Baseline, 3, 6, 9, 12, 18 month)
Fasting venous sample(Baseline, 3, 6, 9, 12, 18 month)
8-year Diabetes Risk(Baseline, 3, 6, 9, 12, 18 month)
Metabolic Syndrome Severity Score(Baseline, 3, 6, 9, 12, 18 month)
Behavioral Risk Factor Surveillance System (BRFSS)(Baseline, 3, 6, 9, 12, 18 month)
Substance Use(Baseline, 12, 18 month)
Neighborhood Environment Walkability Scale (NEWS)(Baseline, 3, 6, 9, 12, 18 month)
Social Support for Healthy Eating (SSEH)(Baseline, 3, 6, 9, 12, 18 month)
Quality of Life(Baseline, 3, 6, 9, 12, 18 month)
Self-Rated Abilities for Health Practice(Baseline, 3, 6, 9, 12, 18 month)
Social Support for Physical Activity (SSPA)(Baseline, 3, 6, 9, 12, 18 month)
Care Partner Healthy Lifestyle Support Tool(Baseline, 3, 6, 9, 12, 18 month)
Telehealth Usability and Satisfaction(6, 12, 18 month)
Exit Survey & Interview(12 or 18 month)