Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group Lifestyle Balance.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Group Lifestyle Balance
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 resulte
Primary outcome measures
- Change in weight [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
Secondary outcome measures (12)
- HbA1c [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- Fasting blood glucose [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- Lipid panel [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- Circumference [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- Height [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- Blood pressure [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- 8-year Diabetes Risk [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- 6 Minute Walk Test (6MWT) [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- 10 Meter Walk Test (10MWT) [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- Behavioral Risk Factor Surveillance System (BRFSS) [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- Neighborhood Environment Walkability Scale (NEWS) [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
- Short Assessment of Health Literacy [Time frame: [Time Frame: Baseline, 3, 6, and 12 months]]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Contraindications for physical activity
- Low Cognitive Function
- Residing in hospital, acute rehab, SNF
- Not fluent in English or Spanish
- Pre-existing eating disorder
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Baylor Institute for Rehabilitation — Dallas
Identifiers
NCT: NCT06517459 · 024-268