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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telehealth lifestyle program called Group Lifestyle Balance for People Post Stroke (GLB-CVA), designed for individuals who have experienced a stroke. The goal is to determine if this program can help participants lose 5-7% of their body weight through healthy eating and physical activity, compared to those who wait six months to start. It is ideal for those who had a stroke over a year ago, have a BMI of 25 or more, and can engage in physical activities. Participants must also have access to a phone, computer, or the internet.

As an unphased trial, this study offers a unique opportunity to explore a new lifestyle program that could significantly enhance health and well-being.

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 prior data suggests that the telehealth lifestyle program for stroke is safe?

Research shows that the Group Lifestyle Balance program for people who have had a stroke (GLB-CVA) is generally easy to follow. Previous studies on the GLB-CVA have shown positive results, with participants losing weight and improving their health without major side effects. The program emphasizes healthy eating and physical activity to help individuals lose 5-7% of their weight.

Since this trial is in the "Not Applicable" phase, it evaluates the program's effectiveness rather than testing a new drug, resulting in few safety concerns. Delivered through telehealth, the program offers convenience and reduces risks associated with in-person visits. Overall, evidence supports the safety and benefits of the GLB-CVA for people who have had a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Lifestyle Program for Stroke because it offers a unique approach to stroke recovery and management. Unlike traditional in-person rehabilitation programs, this program is delivered through telehealth, making it accessible to more people, especially those with mobility challenges. The program adapts the proven Diabetes Prevention Program's lifestyle balance techniques specifically for stroke survivors, aiming to achieve a 5-7% weight loss through healthy eating and physical activity. This combination of weight management and remote delivery could potentially improve recovery outcomes and quality of life for stroke patients, offering a convenient and effective alternative to standard care.

What evidence suggests that the telehealth lifestyle program is effective for stroke recovery?

Research shows that the Group Lifestyle Balance for People Post Stroke (GLB-CVA) program, which participants in this trial may receive, can help individuals who are overweight or obese after a stroke lose weight and improve their health. Studies have found that participants in this program can lose about 5-7% of their body weight by reducing calorie intake and increasing exercise to about 150 minutes of moderate activity each week. Specifically, one study found that people in the program lost about 7.4 pounds, while those not in the program did not lose any weight. This program is based on a successful method used to prevent diabetes and has been adapted to help stroke survivors achieve similar health benefits. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Contraindications for physical activity

Pre-existing eating disorder

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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-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 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 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]

Citations

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Through network meta-analysis, this study compared 8 rehabilitation training exercises effective for balance recovery after stroke, including core muscle group ...