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

NCT03873467 | Active Not Recruiting

• 1 other identifier: BSWRI 018-714
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Group Lifestyle Balance; Physical Activity; Stroke; Weight-loss; Dietary Behaviors

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g., walker; wheelchair).

  Baseline, 3, 6, 12 months

Secondary Outcomes (29)

• Physical Activity

  Baseline, 3, 6, 12 months

• Arm Circumference

  Baseline, 3, 6, 12 months

• Blood Pressure

  Baseline, 3, 6, 12 months

• Cholesterol

  Baseline, 3, 6, 12 months

• Risk of Diabetes

  Baseline, 3, 6, 12 months

Study Arms (2)

GLB Weight-Loss Intervention

EXPERIMENTAL

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).

Behavioral: Group Lifestyle Balance

Wait-List Control

OTHER

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.

Other: Usual Care

Interventions

Group Lifestyle Balance BEHAVIORAL

The Group Lifestyle Balance (GLB) program is a self-management intervention that has been shown to result in weight-loss and reduce the risk for Type 2 diabetes through increased physical activity and healthy eating behaviors in the general population. The GLB is a direct adaptation of the Diabetes Prevention Program, both developed at the Diabetes Prevention and Support Center at the University of Pittsburgh. The GLB is designed for delivery in a group-based, community setting, and has resulted in weight-loss in a variety of settings, such as community centers, churches, worksites, and healthcare systems. The GLB curriculum used in this study has been adapted for people with stroke.

GLB Weight-Loss Intervention

Usual Care OTHER

Participants randomized to the wait-list control group will receive usual care for 6 months before beginning the modified GLB program.

Wait-List Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location

Related Publications (2)

• Driver S, McShan E, Swank C, Grobe K, Calhoun S, Bailey R, Kramer K. Creating an appropriate adaptation of a healthy lifestyle intervention for people after stroke. Brain Inj. 2020 Sep 18;34(11):1497-1503. doi: 10.1080/02699052.2020.1808703. Epub 2020 Aug 19.

  PMID: 32813569 BACKGROUND

• Driver S, Swank C, Froehlich-Grobe K, McShan E, Calhoun S, Bennett M. Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Oct 18;8(10):e14338. doi: 10.2196/14338.

  PMID: 31628790 BACKGROUND

MeSH Terms

Conditions

Stroke; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon J Driver, PhD

  Baylor Scott & White Institute for Rehabilitation (BSWIR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will be masked to group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (RCT). Participants will be randomized into one of two groups: (1) the GLB Intervention Group and (2) the wait-list controlled group.

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 13, 2019
• Study Start: July 8, 2019
• Primary Completion: December 30, 2022
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

US (1)