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临床试验/NCT01647438
NCT01647438已完成不适用

Translating a Heart Disease Lifestyle Intervention Into the Community

Northwestern University4 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
4
主要终点
Change in Physical Activity (Minutes/Week)

研究概览

简要总结

Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle intervention to improve the cardiovascular health of underserved South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will be randomly assigned to either a group to receive heart disease prevention classes or to another group where they will receive written materials about heart disease prevention.

详细描述

South Asian individuals were recruited from a community based organization in Chicago and randomly assigned to the print health education group or the SAHELI intervention.

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
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • South Asians between 30 and 60 years
  • Have at least one CHD risk factor: obesity (body mass index > 25 kg/m2- cutoff for obesity in South Asians), hyperlipidemia, hypertension, pre-diabetes, or diabetes.

排除标准

  • Inability to speak English, Hindi, or Urdu
  • History of clinically evident CVD (e.g. heart attack, stroke)
  • Pregnant, lactating, or planning to become pregnant during the study period
  • Conditions that inhibit moderate intensity physical activity
  • Systolic blood pressure ≥190 or diastolic blood pressure ≥105; Triglycerides ≥ 400
  • Using insulin for diabetes
  • Significant medical or psychiatric co-morbidities
  • Plans to move out of the area within 2 years
  • Family/household member enrolled in study

结局指标

主要结局

Change in Physical Activity (Minutes/Week)

时间窗: baseline and 6-months

Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.

Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake

时间窗: baseline and 6-months

Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months

次要结局

未报告次要终点

研究者

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

Namratha Kandula

Dr. Namratha Kandula, MD, MPH

Northwestern University

研究点 (4)

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