Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
NCT Number: NCT06517459
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: BEHAVIORAL: Group Lifestyle Balance
Sponsor: Baylor Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2025-01-01
Completion Date: 2026-08-31

Summary:
The purpose of this trial is to examine weight loss for Hispanic/Latino people with stroke (CVA) who take part in a healthy lifestyle program that has been culturally modified for Hispanic/Latino people

Primary Outcome Measures: Change in weight, Weight will be measured during in-person assessments at BSWIR using a Seca 664 scale. Height will be measured using a stadiometer. Weight and height will be used to calculate BMI. A BodyTrace Smart Scale will be provided to participants to facilitate self-weighing in the home, which include cellular connectivity at no cost to participants so weight will be sent directly to the research team., [Time Frame: Baseline, 3, 6, and 12 months]
Secondary Outcome Measures: HbA1c, Fasting venous sample will be obtained for hemoglobin a1c to assess average blood sugar level over the past 2-3 months. Fasting venous samples will also be collected for fasting blood glucose, HDL/LDL, total cholesterol, and triglyceride level. Coordinators are trained phlebotomists, [Time Frame: Baseline, 3, 6, and 12 months]|Fasting blood glucose, Fasting venous sample will be obtained for hemoglobin a1c to assess average blood sugar level over the past 2-3 months. Fasting venous samples will also be collected for fasting blood glucose, HDL/LDL, total cholesterol, and triglyceride level. Coordinators are trained phlebotomists, [Time Frame: Baseline, 3, 6, and 12 months]|Lipid panel, Fasting venous sample will be obtained for hemoglobin a1c to assess average blood sugar level over the past 2-3 months. Fasting venous samples will also be collected for fasting blood glucose, HDL/LDL, total cholesterol, and triglyceride level. Coordinators are trained phlebotomists, [Time Frame: Baseline, 3, 6, and 12 months]|Circumference, Waist circumference measured at the umbilicus and mid-upper arm circumference following ACSM guidelines., [Time Frame: Baseline, 3, 6, and 12 months]|Height, Will be collected using a stadiometer and used to calculate BMI, [Time Frame: Baseline, 3, 6, and 12 months]|Blood pressure, Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded, [Time Frame: Baseline, 3, 6, and 12 months]|8-year Diabetes Risk, The Framingham Heart Study diabetes risk score83 will be calculated using predictors including age, gender, fasting glucose, BMI, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials. The age range for this score is 45 years to 64 years, and therefore only individuals within this age will have calculated scores. Furthermore, the minimum cut-off score is 3., [Time Frame: Baseline, 3, 6, and 12 months]|6 Minute Walk Test (6MWT), Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity., [Time Frame: Baseline, 3, 6, and 12 months]|10 Meter Walk Test (10MWT), Assesses walking speed in (m/s) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline., [Time Frame: Baseline, 3, 6, and 12 months]|Behavioral Risk Factor Surveillance System (BRFSS), The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items., [Time Frame: Baseline, 3, 6, and 12 months]|Neighborhood Environment Walkability Scale (NEWS), NEWS assesses participants' perception of neighborhood features related to physical activity and grocery shopping, including residential density, land use mix (including both indices of proximity and accessibility), street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction., [Time Frame: Baseline, 3, 6, and 12 months]|Short Assessment of Health Literacy, Combined word recognition test and comprehension test using multiple-choice questions. Identifies individuals with low health literacy., [Time Frame: Baseline, 3, 6, and 12 months]|Self-Rated Abilities for Health Practice, Includes 28 items to assess health behaviors among people with disabilities and yields a total Health Practices Score plus 4 subscale scores (Exercise, Nutrition, Health Practices, and Psychological Well Being). Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher self-efficacy for the health behaviors., [Time Frame: Baseline, 3, 6, and 12 months]|Stroke Impact Scale - Quality of Life, Quality of life will be assessed using the Stroke Impact Scale, which assesses 8 dimensions of health-related quality of life specific to people post stroke including subscales (using a 5pt Likert scale) assessing strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand function, and participation/role function., [Time Frame: Baseline, 3, 6, and 12 months]|Change in Exit Survey, Participants will be asked to complete an exit survey at the 12-month assessment, asking about experience in, and satisfaction with, the GLB-CVA Latino (including satisfaction and feasibility with modifications and language translation) and suggestions for improvement., [Time Frame: 12 months]|Brief Acculturation Scale for Hispanics, 4 item language based measure of acculturation for Hispanic populations., [Time Frame: Baseline, 3, 6, and 12 months]|Social Support for Eating Habits, Questionnaire that assesses the frequency of support received from others for healthy eating habits over the past 3 months., [Time Frame: Baseline, 3, 6, and 12 months]|Social Support for Physical Activity, Questionnaire that assesses the frequency of support received from others for engaging in physical activity over the past 3 months, [Time Frame: Baseline, 3, 6, and 12 months]