跳至主要内容
临床试验/NCT06643806
NCT06643806已完成不适用

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 Jersey1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
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 cardiovascular disease (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 New Jersey (N.J.)? 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
是

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.

研究组 & 干预措施

Experimental

Experimental

Twenty marital dyads from the site randomly assigned as the intervention site(s) will receive the 12- week peer leader-facilitated dyadic intervention. Topics over the 12 week intervention will address stress management, family history and genetic risk, dietary habits, physical activity and social support/community engagement.

干预措施: CHAI dyad study (Behavioral)

Control

Active Comparator

Twenty dyads from the site randomly assigned as the "usual care" control group site will receive a basic cardiovascular lifestyle modification program. This program will be similar to a classic cardiac rehabilitation program and will consist of diet, physical activity and medical management.

干预措施: CHAI dyad study (Behavioral)

结局指标

主要结局

Risk of CVD

时间窗: 10 weeks

Measured by the QRISK3- The score estimates the likelihood (percentage) of a person developing CVD over the next 10 years. The higher the percentage, the greater the likelihood that they will suffer a heart attack or stroke in the next ten years. A 10-year risk \<10% is considered low, 10-20% moderate, and \>20% high. Collected data are entered into the QRISK3 calculator online Factors involved in the calculation include age, gender, ethnicity, smoking status, history of T2DM, history of hypertension, systolic BP, cholesterol/HDL. ratio, and BMI. Data are entered into Citation- Development and validation of QRISK3 risk prediction algorithms to estimate future risk of cardiovascular disease: prospective cohort study, BMJ 2017;357:j2099

Risk of CVD

时间窗: 13 weeks

Measured by the QRISK3

次要结局

  • Acculturation Stress(10 weeks)
  • Perceived Stress(10 weeks)
  • Body Composition(10 weeks)
  • Waist Circumference(10 weeks)
  • Hemoglobin A1c(10 weeks)
  • Lipid Panel(10 weeks)
  • Inflammation(10 weeks)
  • Genetic Risk of CVD(10 weeks)
  • 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 D'Alonzo

Professor

Rutgers, The State University of New Jersey

研究点 (1)

Loading locations...

相似试验