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临床试验/NCT04708574
NCT04708574已完成不适用

Impact of Lifestyle Changes on Reducing Risk Factors for Type 2 Diabetes Among Arab Canadian Muslim Women.

Western University, Canada2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Change from baseline to post intervention for estimated fitness assessment test

研究概览

简要总结

Aim: The purpose was to investigate whether modifiable risk factors for type 2 diabetes can be reduced by an intensive healthy lifestyle intervention designed for Arab Muslim women.

Methods: Women were assigned randomly to either an Exercise and Nutrition Group (ENG) or a Control Group (CG). The ENG attended a women-only supervised exercise program that presented Arabic music and traditional Lebanese Dabka steps three times/week in the Mosque Gym for 12 weeks. A nutritionist was available one hour/week for nutrition education. The CG followed their typical day.

详细描述

Women were assigned randomly using a computer-generated random numbers table to either an Exercise and Nutrition Group (ENG) or a Control Group (CG). The women received step-by-step instructions on how to complete a consecutive 3-day food record (including two week-days and one weekend day) and an exercise log for 7 days using a pedometer (YAMAX SW-200 Digi-Walker) to determine steps/day. The information and instruction were delivered to the women in English or Arabic. Body weight and height were measured to the nearest 0.1 kg and 0.1 cm, respectively. Women came to the lab after a 12 hour fast and a blood sample was drawn. Waist and hip measurements were taken along with resting blood pressure. Estimated fitness levels was measured by a trained kinesiologist using a Step Test (Siconolfi et al. 1985). All baseline measurements, including the 3-day food intake record and the 7-day pedometer step count log were repeated at the end of the 12-week intervention in both groups. The ENG group attended a supervised women-only exercise program that presented Arabic music and traditional dance steps (the Lebanese Dabka) three times a week in the London Muslim Mosque Gym and received nutrition education over the 12 weeks, one session per week.

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
None

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • family history of type 2 diabetes (at least one parent),
  • overweight or obese,
  • been in Canada more than 10 years,
  • mild hypertension,
  • impaired glucose tolerance, or previous gestational diabetes (including giving birth to babies 4.0 kg or more),
  • a sedentary lifestyle

排除标准

  • uncontrolled hypertension,
  • unstable angina,
  • pulmonary and metabolic disease,
  • severe arthritis or rheumatologic problems,
  • already engaged in regular exercise training,
  • pregnancy,
  • menopause,
  • already enrolled in a clinical research trial

结局指标

主要结局

Change from baseline to post intervention for estimated fitness assessment test

时间窗: Baseline and at the end of the 12 weeks

Step test

Change in nutrition assessment from baseline to post intervention

时间窗: Baseline and at the end of the 12 weeks

From a 3-day food intake record

次要结局

  • Change in blood pressure (systolic and diastolic) values from baseline to post intervention(Baseline and at the end of the 12 weeks)
  • Change in blood glucose values from baseline to post intervention(Baseline and at the end of the 12 weeks)
  • Change in steps per day from baseline to post intervention(baseline (7 days) and at the end of the 12 weeks (7 days))
  • Change in waist to hip ratio from baseline to post intervention(Baseline and at the end of the 12 weeks)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Mottola

Professor

Western University, Canada

研究点 (2)

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