此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Effects of Physical Activity Coaching on Health and Behaviour Parameters in Diabetic Persons

2016年6月3日 更新者:Prof Filip Boen、Universitaire Ziekenhuizen KU Leuven

Short and Long Term Effects of Physical Activity Coaching on Physical Activity, Physical Fitness, Subjective Well Being and Health in Diabetic Persons

In this project the investigators like to develop a methodology to stimulate more physical activity in inactive diabetic persons by an adapted physical activity program. An individually oriented and medically adapted exercise plan will be set up. Participants will be stimulated to be physically active in the long term, even when the coaching has been finished.

In a randomized controlled trial the health effects of the coaching are studied in the short and long term. This trial, in addition to a process evaluation by all stakeholders, gives more information about the implementation of the project in Flanders.

研究概览

地位

完全的

条件

详细说明

Being physically active on a regular base makes part of a healthy lifestyle. Research has shown several positive effects of physical activity on physical and mental health. This is also the case in diabetic persons, who are more vulnerable for certain diseases (e.g. cardiovascular diseases).

However, a lot of people are not interested and motivated to participate in the local exercise activities. The offer often does not satisfy the different needs of those subjects or the barriers for participating are too high. Diabetic persons are also confronted with these problems. However, physical activity is an important part in the treatment of the disease. There is an urgent need for accessible physical activity programs which motivate diabetic persons to adapt a healthy lifestyle, in the short and long term.

A physical activity coach can set up a physical activity plan, individually adapted and according to the medical needs of a diabetic person. This program is created, based on the principles of need supportive coaching.

In this project the researchers will investigate the effects of an individually adapted physical activity plan on health and behavior in diabetic persons. The focus of this project will be on the tertiary prevention. For the recruitment of the subjects, there will be a collaboration with a health insurance company in Belgium (CM).

Communication: Possible participants (cfr database CM) will receive a letter with the invitation of an information session. This information session handles about the importance of being physically active enough in diabetic persons and will present the project where participants are guided by a physical activity coach.

Information session: In the end of the session, participants can register for the physical activity coaching.

Screening: All General Practitioners in the neighborhood were informed about the project, several weeks before the information sessions took place.

Before starting the physical activity coaching, participants have to visit their General Practitioner. The doctor will perform a screening and will decide if the subject is able to participate. For this screening, a fixed protocol is set up by the investigators.

Set up: This study is a randomized controlled trial. An intervention (60 subjects) - and control (40 subjects) group will be included in the study. CM will recruit these people by looking in the database (only people with type 2 diabetes and intake of oral antidiabetic medications will be included). The control group will operate as a waiting group. It means that in the first 6 months of the project, the subjects of the control group will only be measured and will not receive any intervention.

Following measure moments will take place:

Intervention group: pretesting (start), posttest (after 6 weeks), follow up 1 (after 6 months), follow up 2 (after 12 months).

Control group: baseline 1 (start), baseline 2 (after 6 weeks), pretesting (after 6 months), posttest (after 6 months + 6 weeks).

The intervention and control group receive an intervention (group sessions + physical activity plan) between pretest and posttest.

研究类型

介入性

注册 (实际的)

48

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Vlaams Brabant
      • Leuven、Vlaams Brabant、比利时、3000
        • KU Leuven

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

In this project, there is a collaboration with a health insurance company in Flanders (CM). CM will use a database of possible participants for the communication of the project.

Participants have to meet the following inclusion criteria:

  • Suffering from diabetes type 2, with minimal 3 months of intake of oral antidiabetics.
  • Member of CM
  • Owner of a Global Medical File
  • Above 18 years of age

Exclusion Criteria:

In this project, we aim for inactive diabetic subjects. Persons who have more than 30 minutes of moderate exercise a day, will be excluded

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention group

Physical activity coaching: Participants will be coached by a professional physical activity coach through individual and group sessions.

Intake: This talk (1 hour) is the start of the coaching. A physical activity plan will be set up, according to the needs and possibilities of the participant. Activities in leisure time and daily physical activity will be included.

Group sessions: During 5 weeks and one time a week, the subjects will take part in the exercise lessons. About 5 subjects will be in one group and all sessions are supervised by a professional physical activity coach. Activities are walking, Nordic walking and conditional fitness.

Evaluation: After the 5 weeks of group sessions, an evaluation moment will take place between each participant and the physical activity coach. The physical activity plan will be refined.

Comparison the effects of physical activity coaching and no coaching on different health parameters in diabetic subjects
无干预:Control group
The control group will operate as a waiting group. It means that in the first 6 months of the project, the subjects of the control group will only be measured and will not receive any intervention.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Weight
大体时间:Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)
Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write weight
Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)
Psychological parameters
大体时间:change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Psychological parameters are determined by psychological questionnaires. The researchers will investigate motivation, well being, self-efficacy and social support.
change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Blood pressure
大体时间:change in blood pressure between different time points: pre, post (6 weeks), follow-up 1 (6 months), follow-up 2 (12 months)
Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write blood pressure
change in blood pressure between different time points: pre, post (6 weeks), follow-up 1 (6 months), follow-up 2 (12 months)
HbA1c
大体时间:change in HbA1c between different time points: pre, post (6 weeks), follow up 1 (6 months), follow up 2 (12 months)
Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write down HbA1C value, taken by a blood sample
change in HbA1c between different time points: pre, post (6 weeks), follow up 1 (6 months), follow up 2 (12 months)
Sedentary behavior
大体时间:change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Subjective sedentary behavior is determined by a questionnaire.
change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Physical activity
大体时间:change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Level of physical activity is determined by means of an objective physical activity monitor which has to be carried on the upper arm for 1 week.
change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Physical fitness
大体时间:change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)
Physical fitness is determined by means of the 6 minutes walking test.
change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Filip Boen, Prof、KU Leuven

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年2月1日

初级完成 (实际的)

2015年8月1日

研究完成 (实际的)

2015年9月1日

研究注册日期

首次提交

2014年2月11日

首先提交符合 QC 标准的

2014年2月13日

首次发布 (估计)

2014年2月17日

研究记录更新

最后更新发布 (估计)

2016年6月6日

上次提交的符合 QC 标准的更新

2016年6月3日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅