Results of a 12-Month Randomized Controlled Trial Testing the Efficacy of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) for People Post Stroke (GLB-CVA).

BACKGROUND: Experience of stroke is associated with an increased risk for diabetes and metabolic syndrome, yet few interventions exist that have been tailored to the population's unique needs. PURPOSE: To examine adherence and efficacy of the Diabetes Prevention Program Group Lifestyle Balance program (DPP-GLB) modified for individuals post stroke (GLB-CVA) using a randomized controlled trial. METHODS: Adults (18-85 years of age), >12 months post stroke, and body mass index ≥25 kg/m2 were included in this study. Sixty-five individuals were assigned to either the GLB-CVA intervention or a 6-month wait-list control. Participants completed the 12-month GLB-CVA intervention, with attendance and assessment of weight, anthropometric, biomarker, functional, and patient reported outcome data collected at baseline, 3, 6, and 12 months. RESULTS: High attendance (90%) and dietary and activity tracking (71%) suggest high adherence to the 12-month GLB-CVA. Six-month randomized controlled trial data indicate significant weight loss (p = .005) in the GLB-CVA group (7.4 ± 13.6 lbs, 3.65%) compared with the wait-list control (0.1 ± 10.1 lbs, 0%), and improvements in arm circumference (p = .04), high-density lipoprotein (HDL) cholesterol (p = .028), 8-year diabetes risk (p = .011), and pain interference (p < .001). Combined 12-month data showed participants lost 10.1 ± 16.8 lbs (4.88%) and improved waist circumference (p = .001), HbA1c (3.6%), diastolic blood pressure (p < .001), pain (p = .001), social participation (p = .025), and eating practices (p = .01) and habits (p < .001). CONCLUSIONS: Engagement in the GLB-CVA can result in weight loss and improved health for individuals who are overweight or obese following stroke. Future efforts should examine effectiveness in real-world settings and focus on knowledge translation efforts.

Experience of stroke is associated with an added risk for diabetes and metabolic syndrome, yet few interventions exist that have been tailored to the population's unique needs. Our team delivered a health promotion program called the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) modified for individuals post stroke (GLB-CVA) living in the community. We enrolled 65 adults (18­85 years of age), who were at least 12 months post stroke, and had body mass index of at least 25 kg/m2. Participants were randomized to either the GLB-CVA intervention or a 6-month wait-list control. Outcome data were collected at baseline, 3, 6, and 12 months. Results showed high participant attendance (90%) and tracking completion (71%). Participants in the GLB-CVA intervention group lost significantly more weight (3.65%) and had greater improvements in arm circumference, HDL cholesterol, 8-year diabetes risk, and pain than participants in the wait-list control. Combined 12-month data showed participants lost 4.88% of their body weight and improved waist circumference, blood sugar (HbA1c), diastolic blood pressure, pain, social participation, eating practices, and habits. Due to these results, we concluded that engagement in the GLB-CVA can result in weight loss and improved health for individuals who are overweight or obese following stroke.

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

Obesity rates after traumatic brain injury (TBI) are high and are associated with greater risk of morbidity (diabetes, hypertension) and mortality when compared to the general population. Evidence-based interventions for this population are needed and our work modifying and examining the efficacy of the Diabetes Prevention Program Group Lifestyle Balance (GLB-TBI) are promising. Our recent randomized controlled trial included 57 adults with TBI who completed the GLB-TBI in-person and lost 17.8 ± 16.4lbs (7.9% body weight) compared to the attention control (0%). To broaden the accessibility of the intervention we will complete an RCT to assess the efficacy of telehealth delivery (tGLB-TBI) by enrolling 88 participants over a 3 year period. Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health. The long-term goal is to reduce health inequities and broaden program dissemination to people with TBI that lack access due to environmental barriers, including living rurally or lacking transportation.

Efficacy of a group-based education intervention for people with traumatic brain injury: supplementary results from a 12-month randomized controlled trial.

OBJECTIVE: Our team developed an attention control condition, called the Brain Health Group (BHG), for a randomized controlled trial (RCT; NCT03594734). The focus of the BHG was on brain health education and self-management. The objectives of this supplementary analysis are to (1) Describe compliance with the 12-month BHG; (2) Examine efficacy for improving general self-efficacy (GSE, primary) and secondary outcomes; and (3) Describe findings from the program evaluation. DESIGN: English-speaking adults (18-64 years old) who were ≥6 months post a moderate-to-severe TBI were randomized to the BHG (n = 29) or active intervention (n = 28). Data were collected at baseline and 12 months, including GSE, depression, satisfaction with life (SWL), self-rated abilities for health practices (SRAHP), and alcohol use. Program evaluation was conducted at 12 months. RESULTS: Attendance was 89%, and goal tracking was 63%. Within group analysis showed a significant increase in SRAHP scores (p = 0.018). Non-significant increases in GSE and SWL were observed, and participants perceived the BHG as helpful. No significant changes in depression or alcohol use were reported. CONCLUSION: People with TBI can engage in and benefit from the BHG and perceive the program as helpful for improving knowledge about brain health and awareness of self-management skills.

Multisite randomized feasibility study of Problem-Solving Training for care partners of adults with traumatic brain injury during inpatient rehabilitation.

BACKGROUND: Problem-Solving Training (PST) during inpatient rehabilitation could provide care partners the skills needed to manage their life roles after discharge. OBJECTIVE: Determine the feasibility of PST+ Education versus Education for care partners of adults with traumatic brain injury (TBI) during inpatient rehabilitation. METHODS: We conducted a multisite randomized feasibility trial across three sites. We present recruitment rates, reasons for refusal to participate, and reasons for non-completion of interventions. We measured client satisfaction, participant engagement, and fidelity for both interventions. We compared change in depressive symptoms and caregiver burden between PST and Education groups. RESULTS: Though the interventions were generally feasible, recruitment and retention rates were lower than anticipated largely due to the COVID-19 pandemic. Participants who completed >3 sessions were less likely to be employed full-time and more often spouses and co-residing. Length of inpatient rehabilitation stay was correlated with number of sessions completed. We observed potential benefits of PST over Education, specifically for reducing depression symptoms and caregiver burden. CONCLUSION: High satisfaction, engagement, and fidelity, overall recruitment and retention, and positive change in outcomes suggest that PST is generally feasible and beneficial for care partners of persons with TBI. Adaptations, such as developing a 3-session version of PST, could improve feasibility.

Efficacy of the Diabetes Prevention Program Group Lifestyle Balance Program Modified for Individuals with TBI (GLB-TBI): Results from a 12-month Randomized Controlled Trial.

BACKGROUND: Obesity after traumatic brain injury (TBI) is a public health issue and no evidence-based weight loss interventions exist to meet the unique needs of individuals after TBI. PURPOSE: To (a) examine the efficacy of the Diabetes Prevention Program Group Lifestyle Balance for TBI (GLB-TBI) weight-loss intervention compared to an attention control for primary (weight-loss) and secondary health outcomes; (b) determine participant compliance with the GLB-TBI; and (c) determine if compliance is associated with improved outcomes. METHODS: Individuals with moderate to severe TBI, age 18-64 years, ≥6 months postinjury, and body mass index of ≥25 kg/m2 were randomized to a 12-month, 22-session GLB-TBI intervention or attention control condition. Weight-loss (lbs.), anthropometric, biomarkers, and patient-reported outcomes were collected at baseline, 3, 6, and 12 months. RESULTS: The GLB-TBI group (n = 27) lost 17.8 ± 41.4lbs (7.9%) over the 12-month program and the attention control group (n = 27) lost 0 ± 55.4lbs (0%). The GLB-TBI group had significant improvements in diastolic blood pressure, triglycerides, and HDL cholesterol. GLB-TBI attendance was 89.6% and weekly self-monitoring of diet and activity was 68.8%. Relative to baseline, the GLB-TBI compliant group (≥80% attendance; ≥85% self-monitoring; n = 10) had a statistically significant decrease in weight at each assessment, the noncompliant group had a significant decrease between 6 and 12 months (n = 17), with no change in weight in the attention control group (n = 27). CONCLUSIONS: Findings suggest for adults with TBI who are overweight or obese, participation in the GLB-TBI can significantly reduce weight and metabolic risk factors and increase self-reported habits for diet and exercise.

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

PRIMARY OBJECTIVE: To describe (1) an evidence-based approach to promoting a healthy lifestyle, the Diabetes Prevention Program Group Lifestyle Balance intervention, and (2) our work with input from an Advisory Board of stakeholders to modify the program to meet the unique needs of people post stroke. RESEARCH DESIGN: Community-Based Participatory Research. METHODS AND PROCEDURES: An Advisory Board of stakeholders was convened to modify the Group Lifestyle Balance intervention to meet the unique needs of people post stroke. MAIN OUTCOMES AND RESULTS: The primary adaptations that emerged from the Advisory Board included (1) curriculum emphasis on heart health after stroke, (2) care partner participation, (3) physical activity, dietary, and weight loss modifications specific to people after stroke, and (4) general programmatic recommendations (e.g., wider age range of participants; eligibility based on time since stroke; alternative modes of delivery). CONCLUSIONS: Feedback from the diverse group of stakeholders provides the basis for modifying an evidence-based healthy lifestyle intervention to meet the unique needs of people after stroke. Future research efforts should examine the efficacy and effectiveness of the adapted program to prevent weight gain after stroke and reduce the risk of chronic conditions including diabetes, metabolic syndrome, and heart disease.

Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial.

BACKGROUND: Weight gain can be a consequence of stroke, or cerebrovascular accident (CVA), because of impaired mobility, behavioral and emotional disorders, and sensory losses. Weight gain increases the patient's risk of recurrent stroke and chronic diseases, such as diabetes, metabolic syndrome, and pulmonary and heart disease. Approaches to weight loss in this population are lacking, although necessary because of the unique physiological and cognitive needs of persons after a stroke. Evidence shows that intensive behavioral therapy interventions that address both physical activity and diet offer the 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; this program was modified to meet the needs of people who have had a stroke (GLB-CVA). OBJECTIVE: 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 group. METHODS: This RCT will enroll and randomize 64 patients over an 18-month period. RESULTS: Currently, 51 people are waitlisted, with 23 out of 51 screened and 16 out of 23 eligible. CONCLUSIONS: It is anticipated that the findings from this RCT will contribute to the evidence base regarding weight loss strategies for people living with stroke. CLINICAL TRIAL: ClinicalTrials.gov NCT03873467; https://clinicaltrials.gov/ct2/show/NCT03873467.