Group Lifestyle Balance for Stroke

(GLB-CVA Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Must not be taking: Type 2 diabetes medication

Disqualifiers: Low cognition, Pregnancy, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Group Lifestyle Balance, designed to help stroke survivors lose weight and improve health through diet and exercise. The study tracks participants' weight and other health improvements over 3, 6, and 12 months to assess the program's effectiveness. Participants will either start the program immediately or wait six months before joining. This trial is open to individuals who had a stroke at least a year ago, have a BMI of 25 or higher, and have received their doctor's approval. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance post-stroke recovery and improve quality of life.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medication for type 2 diabetes.

What prior data suggests that the Group Lifestyle Balance program is safe for people with stroke?

Research has shown that the Group Lifestyle Balance (GLB) program is generally safe and easy to follow. Designed for people who have had a stroke, this program focuses on weight loss through dietary and exercise changes.

Studies have found that participants in the GLB program can lose weight and improve their health without major safety issues. The program encourages participants to lose 5-7% of their body weight by consuming fewer calories and exercising regularly.

No serious side effects have been reported, making it a safe choice for those wanting to manage their weight and health after a stroke. It is important to consult a healthcare provider to ensure the program is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Group Lifestyle Balance (GLB) program for stroke recovery because it introduces a lifestyle-based approach, rather than relying on medications or surgical interventions. Unlike most treatments that focus on managing stroke symptoms with drugs, this program emphasizes weight loss and increased physical activity, tailoring it specifically for stroke survivors. By promoting a healthy lifestyle, the GLB program aims to reduce the risk of future strokes and improve overall health, offering a proactive and holistic strategy that could complement or even reduce the need for traditional treatments.

What evidence suggests that the Group Lifestyle Balance program is effective for stroke?

Research has shown that the Group Lifestyle Balance (GLB) program can help individuals who have had a stroke lose weight and improve their health. In this trial, participants in the GLB Weight-Loss Intervention arm will engage in the program, which targets a 5-7% weight loss by encouraging reduced calorie intake and increased physical activity—about 150 minutes of moderate exercise each week. One study found that participants in the GLB program lost weight and experienced better overall health. These findings suggest that the GLB program could effectively manage weight in individuals who have experienced a stroke. ^{1 2 3 4 6}

Who Is on the Research Team?

Simon J Driver, PhD

Principal Investigator

Baylor Scott & White Institute for Rehabilitation (BSWIR)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You had a stroke at least 12 months ago.

You have had any type of stroke.

You have a body mass index (BMI) of 25 or higher.

Exclusion Criteria

Not fluent in the English language

Residing in a hospital, acute rehabilitation setting, or skilled nursing facility

You have been diagnosed with an eating disorder before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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.

12 months

22 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Group Lifestyle Balance

Trial Overview 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.

How Is the Trial Designed?

Group I: Wait-List Control Experimental Treatment 1 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 Intervention Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

The Group Lifestyle Balance (GLB-CVA) intervention is a modified 12-month weight loss program specifically designed for stroke survivors, addressing their unique needs and aiming to improve weight and health outcomes.

This randomized controlled trial (RCT) plans to enroll 64 patients over 18 months to evaluate the efficacy of GLB-CVA compared to a waitlist control group, contributing valuable insights into effective weight loss strategies for individuals post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial. Driver, S., Swank, C., Froehlich-Grobe, K., et al.[2020]

A study involving 15 adults with stroke and 10 care-partners identified that stroke-related deficits can hinder participation in the Diabetes Prevention Program-Group Lifestyle Balance (DPP-GLB) program.

Recommendations for adapting the DPP-GLB included modifying session content, adjusting physical activity and dietary guidelines, and involving care-partners to better meet the needs of stroke survivors, which could help reduce their risk of recurrent stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Behavior Change Following Stroke: Recommendations for Adapting the Diabetes Prevention Program-Group Lifestyle Balance Program. Bailey, RR., Stevenson, JL., Driver, S., et al.[2022]

The Diabetes Prevention Program Group Lifestyle Balance intervention was adapted for stroke survivors based on input from an Advisory Board, focusing on heart health, care partner involvement, and tailored physical activity and dietary modifications.

Future research is needed to evaluate the effectiveness of this modified program in preventing weight gain and reducing the risk of chronic conditions like diabetes and heart disease in individuals post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating an appropriate adaptation of a healthy lifestyle intervention for people after stroke. Driver, S., McShan, E., Swank, C., et al.[2021]

A 12-week lifestyle medicine program for poststroke patients led to significant improvements in cardiovascular fitness, with participants increasing their VO2 max by nearly 2 mL O2/min/kg, indicating enhanced aerobic capacity.

The program also resulted in notable reductions in systolic blood pressure among hypertensive participants, with decreases of approximately 9.7 mm Hg when supine and 11.1 mm Hg when standing, suggesting potential benefits for cardiovascular health post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Lifestyle Medicine Program Improves Fitness, Function, and Blood Pressure in Poststroke Veteran Cohort: A Pilot Study. Krauss, J., Frates, E., Parekh, M., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37542523/

Results of a 12-Month Randomized Controlled Trial ... Engagement in the GLB-CVA can result in weight loss and improved health for individuals who are overweight or obese following stroke.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03873467

Group Lifestyle Balance™ for Individuals With Stroke (GLB ... 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 ...

3. researchprotocols.org researchprotocols.org/2019/10/e14338/

Weight Loss After Stroke Through an Intensive Lifestyle ... Objective: This randomized controlled trial (RCT) aims to examine the efficacy of the GLB-CVA on weight and secondary outcomes, compared with ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31628790/

Weight Loss After Stroke Through an Intensive Lifestyle ... This randomized controlled trial (RCT) aims to examine the efficacy of the GLB-CVA on weight and secondary outcomes, compared with that of a waitlist control ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000328

Efficacy of an evidence-based telehealth-delivered weight ... Weight loss after stroke through an intensive lifestyle intervention (group lifestyle balance-cerebrovascular accident): protocol for a randomized controlled ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0939475323003666

Linking biomarkers with healthy lifestyle outcomes after ... Participation in a healthy lifestyle intervention such as the Diabetes Prevention Program Group Lifestyle Balance–adapted for stroke (GLB-CVA) may reduce stroke ...