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

65 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Group Lifestyle Balance for stroke patients?

Research shows that intensive lifestyle programs like Group Lifestyle Balance, which focus on diet and physical activity, can help with weight loss and improve health outcomes for stroke survivors. These programs have been adapted to meet the specific needs of people who have had a stroke, and similar lifestyle interventions have shown improvements in fitness, function, and blood pressure, which are important for stroke recovery and reducing the risk of another stroke. ^{1 2 3 4 5}

Is the Group Lifestyle Balance program safe for stroke survivors?

The Group Lifestyle Balance program, adapted for stroke survivors, has been shown to be safe with no reported adverse events. Participants felt safe to exercise, and satisfaction with the program was high. ^{2 3 6 7 8}

How is the Group Lifestyle Balance treatment different for stroke patients?

The Group Lifestyle Balance treatment is unique for stroke patients because it is a lifestyle modification program originally designed for diabetes prevention, but it has been specifically adapted to address the physical, cognitive, and emotional needs of stroke survivors. This includes tailored physical activity and dietary recommendations, as well as the involvement of care-partners, making it distinct from other treatments that may not consider these specific post-stroke challenges. ^{2 3 6 8 9}

Research Team

Simon J Driver, PhD

Principal Investigator

Baylor Scott & White Institute for Rehabilitation (BSWIR)

Eligibility Criteria

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 are between 18 and 85 years old.

You had a stroke at least 12 months ago.

You have had any type of stroke.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Lifestyle Medicine Program Improves Fitness, Function, and Blood Pressure in Poststroke Veteran Cohort: A Pilot Study. [2022]

2. Canada 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Creating an appropriate adaptation of a healthy lifestyle intervention for people after stroke. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Trends in Diet Counseling Among Stroke Versus Non-Stroke Patients: Evidence from the NAMCS, 2011-2016. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Health Behavior Change Following Stroke: Recommendations for Adapting the Diabetes Prevention Program-Group Lifestyle Balance Program. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating Feasibility of a Secondary Stroke Prevention Program. [2023]

8. England pubmed.ncbi.nlm.nih.gov

'Masterstroke: a pilot group stroke prevention program for community dwelling stroke survivors'. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Enjoyable company in sharing stroke experiences; - lifestyle groups after stroke. [2022]