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临床试验/NCT03336255
NCT03336255已完成不适用

Community Translation of the South Asian Healthy Lifestyle Intervention

Northwestern University2 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2018年3月15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
550
试验地点
2
主要终点
Participants who receive SAHELI intervention may show greater reduction in clinical risk factors for cardiovascular disease compared to the control group.

研究概览

简要总结

Research show that South Asians (SA) have a high burden of Cardiovascular Disease (CVD) risk factors of which, poor diet and physical inactivity remain the major lifestyle risk factors in SA. Intensive diet and physical activity behavioral interventions have been shown to yield improvements across a variety of intermediate cardiovascular health outcomes (blood pressure, cholesterol, glycated hemoglobin, weight) in persons with CVD risk factors and are recommended by national guidelines. However, the investigators prior research found that existing interventions are not reaching SA. First, the usual framing of behavioral risk factor interventions in terms of the biomedical model of CVD is mismatched to SA explanatory models, which emphasize psychosocial causes of CVD. Next, few interventions are tailored to the sociocultural patterns shared by much of the SA community. Interventions that address the individual and shared sociocultural drivers of CVD risk are needed to maximize reach and effectiveness in the high risk and rapidly growing SA population. The proposed study builds on the strong foundation of the South Asian Healthy Lifestyle Initiative (SAHELI), which has a 9-year history of using community-based participatory research to design and test culturally tailored, community-based interventions to reduce CVD disparities in SA. To date, SAHELI has engaged multi-sectoral partners, established relationships of trust, and defined mutually beneficial goals. The investigators also culturally adapted the SAHELI lifestyle intervention to (a) address the individual and sociocultural determinants of CVD risk in SA; and (b) increase components of self-regulation (motivation, self-monitoring, goal setting) that are most effective in eliciting diet and physical activity changes. Hence, the SAHELI intervention integrates evidence-based behavior change techniques with the shared the sociocultural processes salient to SA. A pilot study (n=63) established feasibility of the SAHELI intervention, had a 100% retention rate, and reduced glycated hemoglobin and weight among intervention participants compared to a control group. The proposed study is based on the pilot study and will use a hybrid trial type 1 design to evaluate the clinical effectiveness and implementation potential of the culturally tailored, community-based lifestyle intervention in a larger, more generalizable at-risk SA population. Study team is uniquely positioned to fill a critical gap in work (a) demonstrating the cultural adaptation of evidence-based lifestyle interventions, and (b) evaluating the effectiveness of the SAHELI intervention in reducing CVD risk in SA living in the U.S.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • South Asian adults (18-65 years)
  • Living within the 22 square mile study area
  • Ability to understand Hindi, Urdu, Gujarati or English. AND
  • Body Mass Index of 25 and over and a diagnosis by a doctor of high cholesterol or pre-diabetes/Diabetes, or High blood pressure. OR Body Mass Index of 23 to 24.9 and one clinical risk factors for Cardiovascular Disease (CVD) (CVD risk factors are: Hypertension (Systolic blood pressure >=130 or diastolic blood pressure >=80), abnormal cholesterol (Total cholesterol ≥200, triglycerides >=150),pre-diabetes (A1c between 5.7-6.4%), or diabetes (A1c 6.5 to 10.9),

排除标准

  • History of a CVD event (stroke or heart attack)
  • Being on insulin
  • Blood pressure ≥180/100 mmHg
  • HbA1c ≥11% BMI ≥ 40
  • Current pregnancy
  • Being ≤ 12 months postpartum
  • Any underlying diseases likely to limit lifespan and/or affects ability to exercise.

研究组 & 干预措施

SAHELI Intervention

Experimental

Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 16 to 20 participants who will attend 16 weekly, 90 minute group education sessions at Metropolitan Asian Family Services or Skokie Health Department. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management.

干预措施: South Asian Healthy Lifestyle Initiative (SAHELI) (Behavioral)

Print Health Education

No Intervention

Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.

结局指标

主要结局

Participants who receive SAHELI intervention may show greater reduction in clinical risk factors for cardiovascular disease compared to the control group.

时间窗: 12 months

Total of 550 participants with 50% randomized to SAHELI intervention arm will show significantly greater improvements in clinical risk factors associated with Cardio Vascular Disease (primary outcomes of systolic and diastolic blood pressure, cholesterol, glycated hemoglobin, and weight) relative to a comparison group that receives print education materials on healthy lifestyle.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Namratha Kandula

Professor

Northwestern University

研究点 (2)

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