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Behavioral Intervention

Telehealth Lifestyle Program for Stroke (tGLB-CVA Trial)

N/A

Recruiting

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All types of stroke

≥12 months post first stroke

Must not have

Not fluent in the English language

Diagnosed with or taking medication for Type 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 9, 12, 18 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of telehealth delivery of a program called GLB-CVA to a group that will have to wait 6 months before starting the program.

Who is the study for?

This trial is for individuals who have had a stroke or heart attack. Participants should be stable enough to engage in lifestyle changes via telehealth. Specific eligibility details are not provided, but typically, trials require participants to meet certain health criteria.

What is being tested?

The study is testing the effectiveness of a program called Group Lifestyle Balance (GLB-CVA), delivered through telehealth, for people who've had strokes. It's compared against waiting for 6 months without this intervention in a randomized controlled trial setup.

What are the potential side effects?

Since GLB-CVA involves lifestyle modifications delivered via telehealth, side effects may not be as prominent as drug interventions. However, any potential side effects are not detailed here and would depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a stroke.

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It has been over a year since my first stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not fluent in English.

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I have been diagnosed with Type 2 diabetes or am taking medication for it.

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I have been diagnosed with low cognitive function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 9, 12, 18 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 9, 12, 18 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 9, 12, 18 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight

Secondary study objectives

8-year Diabetes Risk

Behavioral Risk Factor Surveillance System (BRFSS)

Blood Glucose

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Telehealth Group LIfestyle Balance for People with Stroke (tGLB-CVA)Experimental Treatment1 Intervention

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 II: Wait List Control (WLC)Active Control1 Intervention

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.

0 / 5Eligibility criteria met