跳至主要内容
临床试验/NCT06517459
NCT06517459招募中不适用

Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino

Baylor Research Institute2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
2
主要终点
Change in weight

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Contraindications for physical activity
  • Low Cognitive Function
  • Residing in hospital, acute rehab, SNF
  • Not fluent in English or Spanish
  • Pre-existing eating disorder
  • Pregnancy

结局指标

主要结局

Change in weight

时间窗: [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.

次要结局

  • Blood pressure([Time Frame: Baseline, 3, 6, and 12 months])
  • Behavioral Risk Factor Surveillance System (BRFSS)([Time Frame: Baseline, 3, 6, and 12 months])
  • Short Assessment of Health Literacy([Time Frame: Baseline, 3, 6, and 12 months])
  • Fasting blood glucose([Time Frame: Baseline, 3, 6, and 12 months])
  • Lipid panel([Time Frame: Baseline, 3, 6, and 12 months])
  • Circumference([Time Frame: Baseline, 3, 6, and 12 months])
  • 6 Minute Walk Test (6MWT)([Time Frame: Baseline, 3, 6, and 12 months])
  • Height([Time Frame: Baseline, 3, 6, and 12 months])
  • 10 Meter Walk Test (10MWT)([Time Frame: Baseline, 3, 6, and 12 months])
  • Social Support for Physical Activity([Time Frame: Baseline, 3, 6, and 12 months])
  • HbA1c([Time Frame: Baseline, 3, 6, and 12 months])
  • 8-year Diabetes Risk([Time Frame: Baseline, 3, 6, and 12 months])
  • Change in Exit Survey([Time Frame: 12 months])
  • Neighborhood Environment Walkability Scale (NEWS)([Time Frame: Baseline, 3, 6, and 12 months])
  • Self-Rated Abilities for Health Practice([Time Frame: Baseline, 3, 6, and 12 months])
  • Social Support for Eating Habits([Time Frame: Baseline, 3, 6, and 12 months])
  • Stroke Impact Scale - Quality of Life([Time Frame: Baseline, 3, 6, and 12 months])
  • Brief Acculturation Scale for Hispanics([Time Frame: Baseline, 3, 6, and 12 months])

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验