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临床试验/NCT04578067
NCT04578067Unknown不适用

Økt Fysisk Aktivitet og Sunnere Livsstil Hos Innvandrer Kvinner (ASLI)

University of Oslo2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年9月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Change in body weight in kilograms

研究概览

简要总结

The study will include overweight and obese otherwise healthy women, recruited from two main borough in Oslo with the highest population of Somali origin. The study comprises two phases: A 12-months controlled trial where the participants in the intervention borough will be compared to participants in the control borough. This is followed by a 12-months maintaining phase for the intervention borough where the control group will be given the same intervention as the intervention group received during the first 12-months.

详细描述

Through a research-based intervention program, the overall goal of this project is to promote immigrant health by improving, evolving and adapting a preventive healthcare in the municipality. There is social inequalities and geographical differences in health in Norway. Immigrant women struggle more with overweight and obesity than ethnic Norwegian women, and immigrant women have an increased susceptibility for diabetes and other lifestyle related diseases. In this study, we will measure the effect of a culturally tailored intervention package (physical activity and nutrition) on weight reduction, and cardio-metabolic outcomes, among overweight and obese Somali women. The study will include women (aged 20-67 years) recruited from two boroughs in Oslo with the highest population of Somali origin.

The intervention program composes a 12-month controlled trial. The core component of the program is to counsel and empower women through individual counseling and group education sessions with emphasis on physical activities and the creation of an enabling environment. The goal is that the participants become more physically active, less sedentary, eat healthy, and maintain these changes long term.

All main analysis will be done at data collected at the one-year follow up. In addition, the control group in intervention phase will after the completion of the one-year follow up be given the same intervention as the intervention group.

User involvement is included in the development, planning, implementation and dissemination of the program results. The program will produce evidence, relevant for policy-makers and stakeholders locally and globally, of how to improve health and nutrition strategies towards immigrants and minorities. The program represents a collaboration between Oslo municipality, the University of Oslo and the Norwegian School of Sport Sciences.

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
20 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women living in the two boroughs in Oslo with Somali background (born in Somali regions or women born in Norway by two Somali parents), aged 20-67 years
  • Being overweight or obese (BMI ≥27 kg/m2)
  • Not planning to move away from the recruitment area within the next 2 years
  • Not physically active on a regular basis
  • Willing and able to participate in all aspects of the study
  • Must be capable and willing to sign written informed consent and thumb-print for illiterate participants -

排除标准

  • Currently pregnant
  • Participating in a formal exercise or weight loss programme
  • Suffering from serious bone or joint problems or difficulty walking
  • Having known chronic diseases such as diabetes, cancer and uncontrolled hypo- or hyperthyroidism
  • Suffering from other illnesses or being on medications that may affect weight loss
  • Suffering from eating disorders
  • Planning to be out of town for more than 6 weeks in the next 12 months

结局指标

主要结局

Change in body weight in kilograms

时间窗: 1 year

Difference in weight change between intervention and control group

次要结局

  • Change moderately intense physical activity (min/day)(1 year)
  • Change in sedentary time (min/day)(1 year)
  • Change the blood concentration of cholesterol (total, LDL and HDL) (mmol/L)(1 year)
  • Change blood pressure(1 year)
  • Change the blood concentration of HbA1c (mmol/mol)(1 year)
  • Change the blood concentration of triglycerides (mmol/L)(1 year)

研究者

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

Ahmed A. Madar

Researcher

University of Oslo

研究点 (2)

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