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临床试验/NCT06643806
NCT06643806尚未招募不适用

Implementation of a Peer Leader-facilitated Dyadic Intervention to Decrease Cardiovascular Disease Risk Among First Generation Asian Indian Immigrants

Rutgers, The State University of New Jersey0 个研究点目标入组 80 人开始时间: 2025年2月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Risk of CVD

研究概览

简要总结

This Pilot Study Large Application builds upon the results of our prior work to 1) Implement and pilot test a peer leader-facilitated 12-week dyadic intervention (Community Health among Asian Indian immigrants (CHAI) Dyad study) using a cluster randomization design, to decrease CVD risk among first generation AI immigrants; and 2) Assess the feasibility/acceptability of a full-scale intervention. Twenty marital dyads from the site randomly assigned as the intervention site will receive the 12- week peer leader-facilitated dyadic intervention, while 20 dyads from the site randomly assigned as the "usual care" control group site will receive a basic cardiovascular lifestyle modification program. Both groups will meet weekly (90 min. classes) for 12 weeks in a hybrid format (a combination of face to face and remote learning). The intervention is designed to address factors that we identified in our previous study as contributing to a syndemic of cardiovascular disease among AI immigrants including acculturation stress, family history and genetic risk, physical inactivity, as well as a high fat, high-carbohydrate, high-calorie diet.

详细描述

Asian Indian (AI) immigrants, the second largest immigrant group in the US, have a high prevalence of abdominal obesity and premature cardiovascular disease (CVD). Despite ample epidemiological evidence of the need to reduce CVD risk in AIs, few published interventions have addressed this population, primarily focusing on dietary measures and promotion of physical activity, and none of these address immigrant AIs.

This Pilot Study Large Application builds upon the results of our prior work to 1) Implement and pilot test a peer leader-facilitated 12-week dyadic intervention (Community Health among Asian Indian immigrants (CHAI) Dyad study) using a cluster randomization design, to decrease CVD risk among first generation AI immigrants; and 2) Assess the feasibility/acceptability of a full-scale intervention. Twenty marital dyads from the site randomly assigned as the intervention site will receive the 12- week peer leader-facilitated dyadic intervention, while 20 dyads from the site randomly assigned as the "usual care" control group site will receive a basic cardiovascular lifestyle modification program. Both groups will meet weekly (90 min. classes) for 12 weeks in a hybrid format (a combination of face to face and remote learning). The intervention is designed to address factors that we identified in our previous study as contributing to a syndemic of cardiovascular disease among AI immigrants including acculturation stress, family history and genetic risk, physical inactivity, as well as a high fat, high-carbohydrate, high-calorie diet.

Unlike a hypothesis generating study, a pilot study is designed to assess the feasibility/accessibility of an approach to be used in a larger scale study. The following research questions are designed to address feasibility and accessibility of this pilot cluster randomized controlled trial intervention:

Q1 Can the target population of AI immigrant dyads be recruited from faith-based or AI community-based organizations in Central and Northern NJ? Q2 Can the target population of AI immigrant dyads be randomized in a cluster randomized controlled trial? Q3 Can the target population of AI immigrant dyads be retained? Q4 Can the treatments be delivered per protocol? Q5 Will AI immigrant dyads adhere to the treatment protocol? Q6 Are the treatment conditions of the intervention acceptable to AI immigrant dyads?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

We will attempt to enforce community level blinding/masking in this study, but other forms of blinding/masking are not entirely possible in a cluster randomized trial

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • community-dwelling first generation Asian Indian (AI) immigrants (in marital dyads) between the ages of 18-70 years of age who can read and write English and are technology literate.

排除标准

  • AIs not in a marital dyad, those below the age of 20 or above 70 years or those born in the US or visiting the US from India.

结局指标

主要结局

Risk of CVD

时间窗: 13 weeks

Measured by the QRISK3

次要结局

  • Acculturation stress(13 weeks)
  • Perceived stress(13 weeks)
  • Body composition(13 weeks)
  • waist circumference(13 weeks)
  • Hemoglobin A1c(13 weeks)
  • Lipid panel(13 weeks)
  • Inflammation(13 weeks)
  • Genetic risk of CVD(13 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen T. D'Alonzo PhD RN APN-cc.

Associate Professor

Rutgers, The State University of New Jersey

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