Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBaylor Research Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
Body Mass Index ≥25
All types of stroke
Able to Participate in Physical Activity
≥12 months post first stroke
Disqualifiers
Contraindications for physical activity
Low Cognitive Function
Residing in hospital, acute rehab, skilled nursing facility
Not fluent in the English language
Trial design
Design model
Parallel
Treatments tested in this trial
Group Lifestyle Balance for People Post Stroke (GLB-CVA)
Behavioral12-month healthy lifestyle and weight loss program modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB)
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: Wait List Control (WLC)No intervention 0 interventions
Group B: Telehealth Group LIfestyle Balance for People with Stroke (tGLB-CVA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Body Weight
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.
Time frame
Baseline, 3, 6, 9, 12, 18 monthSecondary outcomes
1
Circumference
Waist and hip circumference (centimeters) will be collected from a local Quest Diagnostics
Time frame
Baseline, 3, 6, 9, 12, 18 month2
Height
Height (inches) will be collected from a local Quest Diagnostics
Time frame
Baseline, 3, 6, 9, 12, 18 month3
Body Mass Index (BMI)
Body Mass Index (BMI, kg/m\^2) will be calculated from height and weight from a local Quest Diagnostics
Time frame
Baseline, 3, 6, 9, 12, 18 month4
Blood pressure
Blood Pressure (mmHg, diastolic and systolic) will be collected at a local Quest Diagnostics
Time frame
Baseline, 3, 6, 9, 12, 18 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baylor Research Institute
Lead sponsor
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
Source ClinicalTrials.gov