Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
- Conditions
- Stroke
- Interventions
- Behavioral: Group Lifestyle Balance
- Registration Number
- NCT06517459
- Lead Sponsor
- Baylor Research Institute
- Brief 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
- Detailed Description
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).
Aims:
1. : 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/Latino, available in English and Spanish languages, using a Community-Based Participatory Research approach and AB of key stakeholders (patients, caregivers, clinicians, researchers).
2. : 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/Latino (12 English speakers and 12 Spanish speakers) at 3, 6, and 12 months from baseline.
3. : Evaluate the participant compliance (feasibility) and fidelity (adherence to the DPP GLB content) with the GLB-CVA Latino intervention.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- Contraindications for physical activity
- Low Cognitive Function
- Residing in hospital, acute rehab, SNF
- Not fluent in English or Spanish
- Pre-existing eating disorder
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GLB CVA Latino Group Lifestyle Balance The GLB program, adapted for Latino individuals with stroke, will be delivered to participants over a 12-month period, divided into 22 in-person or virtual, group sessions. The goal of the GLB program is to help the participant achieve and maintain a 5-7% weight-loss using a two-pronged approach: 1. Physical activity: This is based upon recommendations by the American Heart Association and the American College of Sports Medicine (ACSM) to achieve 150 minutes of moderate intensity activity each week. Walking is the primary activity recommended. 2. Healthy eating: Based on United States Department of Agriculture guidelines, the GLB emphasizes healthy eating patterns and tracking dietary intake. Key recommendations include individuals consuming (1) a variety of vegetables, (2) whole fruits, (3) whole grains, (4) fat-free or low-fat dairy, (5) a variety of lean proteins, and (6) oils at every meal
- Primary Outcome Measures
Name Time Method Change in weight [Time Frame: Baseline, 3, 6, and 12 months] 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.
- Secondary Outcome Measures
Name Time Method Blood pressure [Time Frame: Baseline, 3, 6, and 12 months] Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded
Behavioral Risk Factor Surveillance System (BRFSS) [Time Frame: Baseline, 3, 6, and 12 months] 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.
Short Assessment of Health Literacy [Time Frame: Baseline, 3, 6, and 12 months] Combined word recognition test and comprehension test using multiple-choice questions. Identifies individuals with low health literacy.
Fasting blood glucose [Time Frame: Baseline, 3, 6, and 12 months] 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
Lipid panel [Time Frame: Baseline, 3, 6, and 12 months] 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
Circumference [Time Frame: Baseline, 3, 6, and 12 months] Waist circumference measured at the umbilicus and mid-upper arm circumference following ACSM guidelines.
6 Minute Walk Test (6MWT) [Time Frame: Baseline, 3, 6, and 12 months] Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity.
Height [Time Frame: Baseline, 3, 6, and 12 months] Will be collected using a stadiometer and used to calculate BMI
10 Meter Walk Test (10MWT) [Time Frame: Baseline, 3, 6, and 12 months] 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.
Social Support for Physical Activity [Time Frame: Baseline, 3, 6, and 12 months] Questionnaire that assesses the frequency of support received from others for engaging in physical activity over the past 3 months
HbA1c [Time Frame: Baseline, 3, 6, and 12 months] 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
8-year Diabetes Risk [Time Frame: Baseline, 3, 6, and 12 months] 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.
Change in Exit Survey [Time Frame: 12 months] 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.
Neighborhood Environment Walkability Scale (NEWS) [Time Frame: Baseline, 3, 6, and 12 months] 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.
Self-Rated Abilities for Health Practice [Time Frame: Baseline, 3, 6, and 12 months] 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.
Social Support for Eating Habits [Time Frame: Baseline, 3, 6, and 12 months] Questionnaire that assesses the frequency of support received from others for healthy eating habits over the past 3 months.
Stroke Impact Scale - Quality of Life [Time Frame: Baseline, 3, 6, and 12 months] 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.
Brief Acculturation Scale for Hispanics [Time Frame: Baseline, 3, 6, and 12 months] 4 item language based measure of acculturation for Hispanic populations.