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Group Lifestyle Balance for Stroke (GLB-CVA Trial)

N/A

Waitlist Available

Led By Simon J Driver, PhD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the Group Lifestyle Balance program can help people with stroke lose weight and improve other health outcomes.

Who is the study for?

This trial is for individuals aged 18-85 who have had any type of stroke at least a year ago, with a BMI of 25 or higher. They must be able to understand English and not live in a hospital or similar facility. Pregnant individuals, those with eating disorders, low cognition, or conditions that make physical activity unsafe are excluded.

What is being tested?

The study tests the Group Lifestyle Balance (GLB) program tailored for stroke survivors against usual care practices. It measures the effectiveness on weight management and other health outcomes after 3, 6, and 12 months from starting the program.

What are the potential side effects?

Since this trial involves lifestyle changes rather than medication, side effects may include muscle soreness or fatigue due to increased physical activity. Emotional distress could also occur as participants adjust to new diet and exercise routines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 12 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Change in weight

Secondary study objectives

10 Meter Walk Test (10MWT)

6 Minute Walk Test (6MWT)

Arm Circumference

+26 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

Group I: Wait-List ControlExperimental Treatment1 Intervention

The wait-list control group will receive no intervention for 6 months after enrollment. After the 6 month control period, the wait-list control group will receive the GLB Intervention.

Group II: GLB Weight-Loss InterventionExperimental Treatment1 Intervention

The GLB program, adapted for individuals with stroke, will be delivered to participants over a 12-month period, divided into 22 in-person or virtual, group sessions. The intervention promotes 5-7% weight-loss by reducing calories and increasing exercise (150 minutes of moderate physical activity per week).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Group Lifestyle Balance

2015

N/A

~130

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