Telehealth Lifestyle Program for Stroke

(tGLB-CVA Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Cognitive impairment, Hospitalized, Pregnancy, others

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

Compensation: Varies

Number of Visits: 25

94 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Group Lifestyle Balance for People Post Stroke (GLB-CVA)?

The Group Lifestyle Balance (GLB) program, which has been adapted for people who have had a stroke (GLB-CVA), is based on an effective weight loss program used in the general population. Similar adaptations of the program for other conditions, like traumatic brain injury, have shown promising results in weight loss and health improvement, suggesting potential benefits for stroke survivors as well. ^{1 2 3 4 5}

Is the Telehealth Lifestyle Program for Stroke safe for humans?

The Group Lifestyle Balance program, which the Telehealth Lifestyle Program for Stroke is based on, has been used extensively with the general population and adapted for people with stroke. It has been shown to be effective in weight loss and improving health outcomes, suggesting it is generally safe for humans. ^{1 2 3 4 6}

How is the Telehealth Lifestyle Program for Stroke different from other treatments for stroke?

The Telehealth Lifestyle Program for Stroke, specifically the Group Lifestyle Balance for People Post Stroke (GLB-CVA), is unique because it adapts a proven lifestyle modification program originally designed for diabetes prevention to address the specific needs of stroke survivors. This includes modifications to physical activity and dietary recommendations, as well as the inclusion of care-partners, to help reduce the risk of recurrent stroke. ^{1 2 4 5 7}

What is the purpose of this trial?

Investigators will conduct a randomized controlled trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-CVA (tGLB-CVA) compared to a 6-month wait-list control (WLC) in partnership with a diverse group of patient partners and peer mentors.

Eligibility Criteria

This trial is for individuals who have had a stroke or heart attack. Participants should be stable enough to engage in lifestyle changes via telehealth. Specific eligibility details are not provided, but typically, trials require participants to meet certain health criteria.

Inclusion Criteria

I have had a stroke.

Body Mass Index ≥25

Able to Participate in Physical Activity

Exclusion Criteria

I am not fluent in English.

I have been diagnosed with Type 2 diabetes or am taking medication for it.

Pre-existing eating disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Program

Participants engage in 12 weekly telehealth sessions focused on lifestyle balance and weight-loss

12 weeks

12 visits (virtual)

Transition Phase

Participants attend 2 bi-weekly and 2 monthly telehealth sessions to transition from the core program

8 weeks

4 visits (virtual)

Support Phase

Participants continue with 6 monthly telehealth sessions to maintain weight-loss and healthy lifestyle

6 months

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (virtual)

Treatment Details

Interventions

• Group Lifestyle Balance for People Post Stroke (GLB-CVA)

Trial Overview The study is testing the effectiveness of a program called Group Lifestyle Balance (GLB-CVA), delivered through telehealth, for people who've had strokes. It's compared against waiting for 6 months without this intervention in a randomized controlled trial setup.

Participant Groups

Group I: Telehealth Group LIfestyle Balance for People with Stroke (tGLB-CVA) Experimental Treatment 1 Intervention

The telehealth Group Lifestyle Balance for People post stroke (tGLB-CVA) is a one-year program with 22 sessions. The tGLB-CVA is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) developed by the University of Pittsburgh Diabetes Prevention Support Center (DPSC). It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The goal of the tGLB-CVA program is to help the participant achieve and maintain a 5-7% weight-loss through healthy eating and physical activity.

Group II: Wait List Control (WLC) Active Control 1 Intervention

Participants randomized to the wait list control (WLC) will begin the telehealth Group Lifestyle Balance for People post stroke (tGLB-CVA) intervention 6 months after enrolling into the study and completing a baseline assessment.

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

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]

A randomized controlled trial with 57 adults who had traumatic brain injury (TBI) showed that participants lost an average of 17.8 pounds (7.9% of their body weight) after completing the modified Diabetes Prevention Program Group Lifestyle Balance (GLB-TBI), compared to no weight loss in the control group.

To make this weight-loss intervention more accessible, a new randomized controlled trial will test a telehealth version of the program (tGLB-TBI) with 88 participants over 3 years, aiming to help individuals with TBI who face barriers to accessing traditional programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI). Driver, S., McShan, EE., Bennett, M., et al.[2023]

The Group Lifestyle Balance (GLB) program significantly reduced the long-term risk of diabetes and cardiovascular disease by 25.7% among participants in an urban, medically underserved community, based on a study involving 105 individuals over 24 months.

Over half (52.6%) of participants who lost at least 5% of their body weight during the 12-week intervention successfully maintained that weight loss, averaging about 20 pounds less than their baseline weight, highlighting the program's effectiveness in promoting sustainable health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year results of translating the diabetes prevention program into an urban, underserved community. Piatt, GA., Seidel, MC., Chen, HY., et al.[2018]

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 community-based modified Diabetes Prevention Program, called Group Lifestyle Balance (GLB), effectively helped individuals with metabolic syndrome lose weight, with 46.4% of participants losing at least 5% of their body weight after a 12-week intervention.

Improvements in metabolic syndrome components were observed, with 43.5% of participants showing positive changes, and many of these improvements were sustained at a 6-month follow-up, indicating the potential for long-term benefits in reducing the risk of type 2 diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into an urban medically underserved community: a nonrandomized prospective intervention study. Seidel, MC., Powell, RO., Zgibor, JC., et al.[2022]

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]

References

1. 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]

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI). [2023]

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

Two-year results of translating the diabetes prevention program into an urban, underserved community. [2018]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Translating the Diabetes Prevention Program into an urban medically underserved community: a nonrandomized prospective intervention study. [2022]

7. 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]