Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Group Lifestyle Balance.
- Кому может быть актуально
- Состояния в реестре: Stroke. Базовые параметры: 18 лет — 85 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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
Подробное описание
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.
Вмешательства
- Поведенческое 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
Первичные конечные точки
- Change in weight [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
Вторичные конечные точки (12)
- HbA1c [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- Fasting blood glucose [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- Lipid panel [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- Circumference [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- Height [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- Blood pressure [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- 8-year Diabetes Risk [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- 6 Minute Walk Test (6MWT) [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- 10 Meter Walk Test (10MWT) [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- Behavioral Risk Factor Surveillance System (BRFSS) [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- Neighborhood Environment Walkability Scale (NEWS) [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
- Short Assessment of Health Literacy [Срок оценки: [Time Frame: Baseline, 3, 6, and 12 months]]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Contraindications for physical activity
- Low Cognitive Function
- Residing in hospital, acute rehab, SNF
- Not fluent in English or Spanish
- Pre-existing eating disorder
- Pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- Baylor Institute for Rehabilitation — Dallas
Идентификаторы
NCT: NCT06517459 · 024-268