Clinical trial NCT06517459: Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
Official title: Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Weight-loss
Stroke
Group Lifestyle Balance
Dietary Behaviors
Physical Activity
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be assigned to the modified GLB-CVA program, available in Spanish or English.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in weight
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
Secondary outcomes:
measure: HbA1c
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Fasting blood glucose
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Lipid panel
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Circumference
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Height
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Blood pressure
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: 8-year Diabetes Risk
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: 6 Minute Walk Test (6MWT)
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: 10 Meter Walk Test (10MWT)
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Behavioral Risk Factor Surveillance System (BRFSS)
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Neighborhood Environment Walkability Scale (NEWS)
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Short Assessment of Health Literacy
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Self-Rated Abilities for Health Practice
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Stroke Impact Scale - Quality of Life
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Change in Exit Survey
timeFrame: [Time Frame: 12 months]
measure: Brief Acculturation Scale for Hispanics
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Social Support for Eating Habits
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
measure: Social Support for Physical Activity
timeFrame: [Time Frame: Baseline, 3, 6, and 12 months]
Other outcomes:
Locations:
Study officials:
affiliation: Baylor Scott and White Research Institute
name: Librada Callender, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: