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临床试验/NCT04143737
NCT04143737已完成不适用

Community-Based Lifestyle Intervention for Primary and Secondary Prevention of Diabetes in Arab Women in East-Jerusalem, A Quasi-experimental Study.

Hadassah Medical Organization0 个研究点目标入组 60 人开始时间: 2016年3月7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
60
主要终点
Adherence to Mediterranean diet

研究概览

简要总结

Given the extremely high incidence of diabetes in Arab women and the current lack of interventions, all non-diabetic women can be considered "at risk" and warrant secondary prevention. Creating an effective community-based primary and secondary diabetes prevention program has the potential for nationwide reduction of health disparities for Arab women.

The purpose of this study was to investigate the effectiveness of a lifestyle intervention in reducing risky health behaviors and thus reducing modifiable risk factors associated with diabetes and cardiovascular diseases, through dietary modification, adherence to healthy low-caloric, low-fat diet and engaging in physical activity.

详细描述

Given the extremely high incidence of diabetes in Arab women and the current lack of interventions, all non-diabetic women can be considered "at risk" and warrant secondary prevention.

The purpose of this study was to investigate the effectiveness of lifestyle intervention in reducing risky health behaviors and thus reducing modifiable risk factors associated with diabetes and cardiovascular diseases, through dietary modification, adherence to healthy low-caloric, low-fat diet and engaging in physical activity.

Methods: The invistigators will conduct a quasi-experimental, pre-post intervention study between to investigate the effectiveness of community based intervention to change lifestyle habits and consequently reduce the modifiable risk factors for developing diabetes at all levels of prevention. All members of two targeted Arab women's community centers in East-Jerusalem will be invited to participate in the study. Potential participants will be interviewed for eligibility (over age 25, able to commit to the intervention timetable, and precluding pregnancy or serious mental and physical illness).

Participants who will be included in the control group will not receive any intervention. The intervention group will be located in one community center in Zur-Baher neighborhood, and the control group will be located in one community center in the old city of Jerusalem.

Data will be collected from both groups. Intervention: The Community-Based Lifestyle Intervention (CBLI) was developed based on the gold standard Diabetes Prevention Program (DPP) and adapting all intervention components to the specific culture, language, gender, and religious sensitivities of Palestinian female society. The intervention consisted of 20 weekly sessions and will be taught by professional facilitators (nutritionists, exercise trainers, health coaches, and psychotherapists). The DPP's lifestyle curriculum includes sessions on nutrition, physical activity, stress management skills, and self-monitoring and was culturally adapted, translated into Arabic, and gender tailored.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 25 and above
  • Able to commit to the program timetable

排除标准

  • Age younger than25
  • Unable to commit to the intervention timetable
  • Pregnant with expected delivery during the intervention
  • Women with serious mental or physical illness

研究组 & 干预措施

Intervention

Other

38 women participated in the intervention group which was located in a community center in Zur-Baher neighborhood. The intervention consisted of 20 weekly sessions on nutrition, physical activity, stress management skills, and self-monitoring. All taught by professional facilitators (nutritionists, exercise trainers, health coaches, and psychotherapists). Baseline data was collected

干预措施: Healthy lifestyle intervention (Behavioral)

Control

No Intervention

22 women participated in the control group. They were recruited from a community center in the old city of Jerusalem and did not receive any intervention. Baseline data was collected.

结局指标

主要结局

Adherence to Mediterranean diet

时间窗: 6 months after intervention initiation

Adherence to Mediterranean Diet- Eating behaviors will be assessed through self-reported questionnaire adapted from the Attica study. The questions include an assessment of daily average consumption of whole grains, vegetables, fruits, legumes, and low-fat dairy products. The questionnaire includes also food items assessing the consumption of western diet including sweets, sweet drinks and salty snacks. These questions were adapted from the following study: "A Western dietary pattern is associated with higher blood pressure in Iranian adolescents." European Journal of Nutrition 2017 Feb:56(1)399-408.

Change in average daily steps- measured by Pedometer

时间窗: 6 months after intervention initiation

The participants in the intervention group were given a pedometer and weekly step data were collected by the research team.

次要结局

  • Change in Blood pressure (BP)(6 months after intervention initiation)
  • Change in body Mass Index (BMI)(6 months after intervention initiation)
  • Change in Plasma levels of Hemoglobin A1c (HbA1c)(6 months after intervention initiation)
  • Change in Plasma levels of Glucose, HDL, LDL, triglycerides, and total cholesterol(6 months after intervention initiation)
  • Change in Cardiovascular disease knowledge(6 months after intervention initiation)
  • Change in Leadership self-efficacy scale(6 months after intervention initiation)

研究者

申办方类型
Other
责任方
Sponsor

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