Clinical trial NCT03873467: Group Lifestyle Balance™ for Individuals with Stroke (GLB-CVA)
Official title: Efficacy of an Evidence-based Healthy Lifestyle Intervention for People Following CVA
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Group Lifestyle Balance
Physical Activity
Stroke
Weight-loss
Dietary Behaviors
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2019-03-13
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in weight
timeFrame: Baseline, 3, 6, 12 months
Secondary outcomes:
measure: Physical Activity
timeFrame: Baseline, 3, 6, 12 months
measure: Arm Circumference
timeFrame: Baseline, 3, 6, 12 months
measure: Blood Pressure
timeFrame: Baseline, 3, 6, 12 months
measure: Cholesterol
timeFrame: Baseline, 3, 6, 12 months
measure: Risk of Diabetes
timeFrame: Baseline, 3, 6, 12 months
measure: 10 Meter Walk Test (10MWT)
timeFrame: Baseline, 3, 6, 12 months
measure: 6 Minute Walk Test (6MWT)
timeFrame: Baseline, 3, 6, 12 months
measure: Perceived Social Support
timeFrame: Baseline and 12 months
measure: Self-reported activities of health using the Self-Rated Abilities for Health Practice scale
timeFrame: Baseline and 12 months
measure: Neighborhood walkability using Walk Score®
timeFrame: Baseline
measure: Resting Metabolic Rate
timeFrame: Baseline
measure: Behavioral Risk Factor Surveillance
timeFrame: Baseline, 3, 6, 12 months
measure: Participant quality of ife
timeFrame: Baseline, 6, 12 months
measure: Stressful Life Events using the Holmes and Rahe Stress Inventory
timeFrame: Baseline and 12 months
measure: Executive Function and Cognition using the Montreal Cognitive Assessment
timeFrame: Baseline, 3, and 12 months
measure: Habit Formation
timeFrame: Baseline, 3, and 12 months
measure: Stroke Severity
timeFrame: Baseline
measure: Pain Interference
timeFrame: Baseline, 3, 6, and 12 months
measure: Sleep Disturbance
timeFrame: Baseline, 3, 6, 12 months
measure: Waist Circumference
timeFrame: Baseline, 3, 6, and 12 months
measure: HbA1c
timeFrame: Baseline, 3, 6, and 12 months
measure: Triglycerides
timeFrame: Baseline, 3, 6, 12 months
measure: Blood Glucose
timeFrame: Baseline, 3, 6, 12 months
measure: Biomarker Analysis
timeFrame: Baseline, 3, and 6 months
measure: Stages of Change
timeFrame: Baseline, 3, 6, and 12 months
measure: Metabolic Score Calculator (MetS)
timeFrame: Baseline, 3, 6, and 12 months
measure: CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form
timeFrame: Up to 12 months
measure: PROMIS Social Isolation Short Form 4a
timeFrame: Up to 12 months
measure: Media Questionnaire
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation
state: Texas
Study officials:
affiliation: Baylor Scott & White Institute for Rehabilitation (BSWIR)
name: Simon J Driver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.