Group Lifestyle Balance™ for Individuals with Stroke (GLB-CVA)

Baylor Scott and White Health (BSWH)

Status: Active, not recruiting

Conditions: Stroke

Treatments: Other: Usual Care; Behavioral: Group Lifestyle Balance

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03873467

BSWRI 018-714

Details and patient eligibility

About

The purpose of this RCT is to examine the efficacy of the Group Lifestyle Balance (GLB) program adapted for people with stroke (CVA) on primary (weight) and secondary outcomes at 3, 6, 12 months from enrollment into the program.

Full description

Weight gain greatly increases the risk of chronic diseases after stroke such as diabetes, metabolic syndrome, pulmonary and heart disease. Approaches to weight-loss are lacking, yet necessary, due to the unique physiological and cognitive needs of persons with CVA. There is evidence that interventions that improve physical activity and healthy eating behaviors concurrently offer greatest potential for weight-loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight-loss program that has been used extensively with the general population, but not with people after CVA. Investigators modified the program to meet the needs of people post stroke (GLB-CVA).

Study Aims:

The study consists of five specific aims.

Specific Aim 1: To create an appropriate adaptation of the DPP-GLB program that meets the unique needs of people post CVA (GLB-CVA) using a Community-Based Participatory Research approach and Advisory Board of key stakeholders (patients, caregivers, clinicians, researchers).

Specific Aim 2: To establish the feasibility of delivering the GLB-CVA intervention.

Specific Aim 3: Conduct a randomized controlled trial (RCT) to examine the effectiveness of the GLB-CVA on primary and secondary outcomes in the intervention group compared to the wait-list control group at 3, 6, and 12 months from baseline.

Specific Aim 4: Describe the effect of the GLB-CVA on metabolic biomarkers in the experimental group compared to the wait-list control group at baseline, 3, and 6 months.

Specific Aim 5: Describe the association between biomarkers of neurodegeneration and physiologic, functional, and patient reported outcomes at baseline, 3, and 6 months.

Enrollment: 65 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 85 years of age
• BMI ≥25
• All types of stroke
• At least 12 months post first stroke
• Physician approval

Exclusion criteria

• Low cognition
• Not fluent in the English language
• Conditions for which physical activity is contraindicated
• Taking medication for type 2 diabetes
• Residing in a hospital, acute rehabilitation setting, or skilled nursing facility
• Pregnancy
• Pre-existing diagnosis of an eating disorder

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

GLB Weight-Loss Intervention

Experimental group

Description:

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:

Behavioral: Group Lifestyle Balance

Wait-List Control

Other group

Description:

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.

Treatment:

Other: Usual Care