[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06517459":3,"trial-entities:NCT06517459":144,"trial-summary:NCT06517459":147},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":13,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":41,"sex":95,"minimum_age":96,"maximum_age":97,"healthy_volunteers":14,"eligibility_criteria":98,"std_ages":115,"locations":118,"central_contacts":134,"overall_officials":137,"references":142,"see_also_links":143},"NCT06517459","024-268","Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic\u002FLatino","RECRUITING","2026-10-31","2025-10","2025-10-15","2025-05-19","Baylor Research Institute","OTHER",false,"The purpose of this trial is to examine weight loss for Hispanic\u002FLatino people with stroke (CVA) who take part in a healthy lifestyle program that has been culturally modified for Hispanic\u002FLatino people","Weight gain greatly increases the risk of chronic diseases such as diabetes, metabolic syndrome, pulmonary and heart disease. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight-loss program that has been used extensively with the general population and with people after CVA, however, it is not adapted to be linguistically and culturally appropriate for Latino persons post stroke. We will modified the program to meet the needs of Latino people with a CVA (GLB-CVA Latino).\n\nAims:\n\n1. : To create a modification of the CDC-recognized, evidence-based GLB-CVA to be culturally appropriate to meet the unique needs of people who identify as Hispanic\u002FLatino, available in English and Spanish languages, using a Community-Based Participatory Research approach and AB of key stakeholders (patients, caregivers, clinicians, researchers).\n2. : Conduct a single-arm trial to describe the effect of participation in the GLB-CVA Latino on primary and secondary outcomes for 24 individuals who identify as Hispanic\u002FLatino (12 English speakers and 12 Spanish speakers) at 3, 6, and 12 months from baseline.\n3. : Evaluate the participant compliance (feasibility) and fidelity (adherence to the DPP GLB content) with the GLB-CVA Latino intervention.",[18],"Stroke",[20,18,21,22,23],"Weight-loss","Group Lifestyle Balance","Dietary Behaviors","Physical Activity","INTERVENTIONAL",[26],"NA",{"count":28,"type":29},24,"ESTIMATED",[31],{"type":32,"name":21,"description":33,"armGroupLabels":34},"BEHAVIORAL","The Group Lifestyle Balance (GLB) program is a self-management intervention that has been shown to result in weight-loss and reduce the risk for Type 2 diabetes through increased physical activity and healthy eating behaviors in the general population. The GLB is a direct adaptation of the Diabetes Prevention Program, both developed at the Diabetes Prevention and Support Center at the University of Pittsburgh. The GLB is designed for delivery in a group-based, community setting,4 and has resulted in weight-loss in a variety of settings, such as community centers, churches, worksites, and healthcare systems.",[35],"GLB CVA Latino",[37],{"measure":38,"description":39,"timeFrame":40},"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]",[42,45,47,49,52,55,58,61,64,67,70,73,76,79,82,86,89,92],{"measure":43,"description":44,"timeFrame":40},"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\u002FLDL, total cholesterol, and triglyceride level. Coordinators are trained phlebotomists",{"measure":46,"description":44,"timeFrame":40},"Fasting blood glucose",{"measure":48,"description":44,"timeFrame":40},"Lipid panel",{"measure":50,"description":51,"timeFrame":40},"Circumference","Waist circumference measured at the umbilicus and mid-upper arm circumference following ACSM guidelines.",{"measure":53,"description":54,"timeFrame":40},"Height","Will be collected using a stadiometer and used to calculate BMI",{"measure":56,"description":57,"timeFrame":40},"Blood pressure","Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded",{"measure":59,"description":60,"timeFrame":40},"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.",{"measure":62,"description":63,"timeFrame":40},"6 Minute Walk Test (6MWT)","Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity.",{"measure":65,"description":66,"timeFrame":40},"10 Meter Walk Test (10MWT)","Assesses walking speed in (m\u002Fs) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline.",{"measure":68,"description":69,"timeFrame":40},"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.",{"measure":71,"description":72,"timeFrame":40},"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\u002Fcycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction.",{"measure":74,"description":75,"timeFrame":40},"Short Assessment of Health Literacy","Combined word recognition test and comprehension test using multiple-choice questions. Identifies individuals with low health literacy.",{"measure":77,"description":78,"timeFrame":40},"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.",{"measure":80,"description":81,"timeFrame":40},"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\u002Frole function.",{"measure":83,"description":84,"timeFrame":85},"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]",{"measure":87,"description":88,"timeFrame":40},"Brief Acculturation Scale for Hispanics","4 item language based measure of acculturation for Hispanic populations.",{"measure":90,"description":91,"timeFrame":40},"Social Support for Eating Habits","Questionnaire that assesses the frequency of support received from others for healthy eating habits over the past 3 months.",{"measure":93,"description":94,"timeFrame":40},"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","ALL","18 Years","85 Years",{"inclusion":99,"exclusion":107,"raw_text":114},[100,101,102,103,104,105,106],"BMI ≥25","Identify as Hispanic or Latino","18-85 years of age","All types of stroke","Medically able to participate in a weight-loss program","Physical Activity Readiness Questionnaire +","≥12 months post first stroke",[108,109,110,111,112,113],"Contraindications for physical activity","Low Cognitive Function","Residing in hospital, acute rehab, SNF","Not fluent in English or Spanish","Pre-existing eating disorder","Pregnancy","Inclusion Criteria:\n\n* BMI ≥25\n* Identify as Hispanic or Latino\n* 18-85 years of age\n* All types of stroke\n* Medically able to participate in a weight-loss program\n* Physical Activity Readiness Questionnaire +\n* ≥12 months post first stroke\n\nExclusion Criteria:\n\n* Contraindications for physical activity\n* Low Cognitive Function\n* Residing in hospital, acute rehab, SNF\n* Not fluent in English or Spanish\n* Pre-existing eating disorder\n* Pregnancy",[116,117],"ADULT","OLDER_ADULT",[119],{"facility":120,"status":7,"city":121,"state":122,"zip":123,"country":124,"contacts":125,"geoPoint":131},"Baylor Institute for Rehabilitation","Dallas","Texas","75246","United States",[126],{"name":127,"role":128,"phone":129,"email":130},"Alvaro Carrera","CONTACT","4698315321","alvaro.carrera@bswhealth.org",{"lat":132,"lon":133},32.78306,-96.80667,[135],{"name":127,"role":128,"phone":136,"email":130},"469-831-5321",[138],{"name":139,"affiliation":140,"role":141},"Librada Callender, PhD, MPH","Baylor Scott & White The Heart Hospital","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":145,"biomarkers":146},[18],[],{"nct_id":4,"found":148,"summary":149,"prompt_version":159},true,{"design":150,"status":151,"heading":152,"summary":153,"follow_up":154,"word_count":155,"commitments":156,"compensation":157,"drugs_mentioned":158},"This is a single-arm study, meaning all 24 participants will receive the Group Lifestyle Balance (GLB-CVA Latino) intervention. The study will observe participants over 12 months.","completed","Healthy Lifestyle Program for Hispanic\u002FLatino Stroke Survivors","This study is testing a healthy lifestyle program called Group Lifestyle Balance (GLB), which has been changed to better fit the culture and language of Hispanic\u002FLatino people who have had a stroke. The program aims to help you lose weight through healthy eating and physical activity. Researchers want to see how well this modified program, called GLB-CVA Latino, helps with weight loss over 12 months. You might be able to join if you are 18-85 years old, identify as Hispanic or Latino, have a Body Mass Index (BMI) of 25 or higher, and had a stroke at least 12 months ago. The study will enroll 24 participants.","Participants will be followed for 12 months after starting the program, with weight measurements taken at 3, 6, and 12 months.",107,"You would participate in the Group Lifestyle Balance (GLB-CVA Latino) program. Your weight will be measured at the beginning, and again at 3, 6, and 12 months.","Not stated in the trial record.",[21],"v2"]