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临床试验/NCT03914066
NCT03914066终止不适用

A Group-based Treatment of Overweight and Obesity in Primary Care

Region Örebro County1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
39
试验地点
1
主要终点
Weight reduction in kg and % from baseline to 6-8 months and 12 months.

研究概览

简要总结

Overweight and obesity is a growing problem in the world. Today more than 50 % of all people over 18 years in Sweden are overweight or obese. Main reasons for this are changes in lifestyle habits regarding diet and physical exercise. Overweight and obesity increases risk of different diseases such as type 2 diabetes, arthrosis and cancer; it also affects quality of life. Losing 5-10 % of your body weight improves metabolic health and quality of life. Lifestyle changes are very important in order to lose weight but it can be challenging to carry through with these changes on your own without support. In the primary care in Region Orebro län a group treatment, "Step by step", has been in use since 2010. It comprises of six group sessions over 6-8 months with different themes such as diet, physical exercise and stress. Between the group sessions there are home assignments, such as writing a diet or exercise diary. This observational study will evaluate "Step by step" and the effect the group treatment has on the participants' weight, dietary habits, physical activity, quality of life, eating habits and metabolic health.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •18 years and older
  • •BMI 30 or over
  • •BMI over 28 and under 30 with one or more of following: hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidaemia, liver steatosis, sleep apnoea or polycystic ovary syndrome.

排除标准

  • •Severe mental illness
  • •Previous or present eating disorder
  • •Pregnancy
  • •Breast feeding
  • •Serious cancer under treatment
  • •Use of weight-loss drugs
  • •Misuse of alcohol or drugs
  • •Type 1 diabetes
  • •Not being able to speak/read/write Swedish.

研究组 & 干预措施

Group treatment in primary care

Experimental

The intervention is a group treatment of overweight and obesity in primary care inspired by cognitive behavioural therapy. The main goal of the group treatment is for the participants to obtain and maintain healthy lifestyle habits, with emphasis on diet and physical activity. Every group has 8-12 participants and is led by two persons; the main group leader is either a primary care nurse or a physiotherapist with special training. The groups meet six times (2 hours every time) once a month over a 6-8 month period. Every group session has a set agenda with different topics, for example a healthy diet, recommended physical activity or how to deal with setbacks. Between group sessions there are home assignments. The home assignments are followed-up at the next session and participants are encouraged to share experiences with each other in order to inspire, challenge and help fellow group participants. Data is collected prior to the start of group treatment, after 6-8 and 12 months.

干预措施: A group-based treatment of overweight and obesity (Behavioral)

结局指标

主要结局

Weight reduction in kg and % from baseline to 6-8 months and 12 months.

时间窗: Change from baseline to follow-up at 6-8 months and 12 months.

Measured in kilograms

次要结局

  • Change in Systolic and Diastolic Blood pressure(Change from baseline to follow-up at 6-8 months and 12 months.)
  • Change in blood glucose(Change from baseline to follow-up at 6-8 months and 12 months.)
  • Change in blood cholesterol(Change from baseline to follow-up at 6-8 months and 12 months.)
  • Change in blood triglycerides(Change from baseline to follow-up at 6-8 months and 12 months.)
  • Change in Dietary habits(Change from baseline to follow-up at 6-8 months and 12 months.)
  • Change in Physical activity(Change from baseline to follow-up at 6-8 months and 12 months.)
  • Change in general Health-related Quality of Life(Change from baseline to follow-up at 6-8 months and 12 months.)
  • Change in Obesity-specific Health-related Quality of Life(Change from baseline to follow-up at 6-8 months and 12 months.)
  • Change in Eating patterns(Change from baseline to follow-up at 6-8 months and 12 months.)

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Sponsor

研究点 (1)

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