Preventing Diabetes in Those at Risk by Having a Facilitator and Family Doctor Encourage Healthy Activity and Eating Habits (FLIP)
2014年3月4日 更新者:University of British Columbia
Preventing Diabetes With Facilitated Lifestyle Intervention Prescriptions.Phase 2: Pilot Study
Nearly six million Canadians are living with an increased risk of diabetes (prediabetes) and approximately 50% of these will develop type 2 diabetes within five years.
The investigators wish to help these people change their lifestyle, to prevent them from getting diabetes.
Trials have shown that by supporting people with prediabetes to be more active and have healthier eating habits they can halve their risk.
However, these interventions were very costly and not performed in Canada.
With the help of local Family Physicians and other health professionals (e.g.
physiotherapy, psychology, endocrinology, nursing) the investigators have created a less expensive intervention suitable for the Canadian population and health system.
The investigators need to perform a study to see whether these modified approaches are practical for Canadians and likely to be effective.
People at risk will be invited to participate from family practices that have helped us in the initial stages of this program.
Family practices will be randomized to giving either the study intervention or continue with the physician's usual care.
People receiving the intervention will have an appointment with their family doctor to discuss their exercise and eating habits and agree changes that are necessary.
A prescription detailing these changes will be completed and signed by the family physician and participant.
Participants will be given the name of a lifestyle change facilitator (LCF) who will receive a copy of the prescription and contact the participant to help them set achievable goals.
The LCF will contact participants once a month for six months to help them achieve these goals.
The investigators eventual aim is to test this intervention in a large-scale randomized control trial.
To achieve this it is necessary to pilot all aspects of the trial.
Information from the pilot study can then be used to design and perform a large-scale study effectively.
The investigators hope that eventually the numbers of Canadians progressing to having diabetes will be reduced.
研究概览
研究类型
介入性
注册 (实际的)
59
阶段
- 阶段2
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
-
-
British Columbia
-
Vancouver、British Columbia、加拿大、V6T 1Z3
- UBC Family Practice
-
-
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
18年 及以上 (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
Inclusion Criteria:
- Adults aged ≥ 18 years
- HbA1c of 5.7 to 6.4% and/or FPG of 6.1 to 6.9 mmol/l and/or a 2hr 75g OGTT of between 7.8 and 11.0 mmol/l
Exclusion Criteria:
- People with Type I or II diabetes
- Unstable angina
- Uncontrolled congestive heart failure
- Unstable arrhythmia
- Heart valvular disease
- Severe hypertension (systolic ≥ 200 or diastolic ≥ 120)
- Pregnant women or planning pregnancy within two years
- Life expectancy < 1 year
- Waiting for major surgery
- High risk of fracture
- Pregnancy or planning pregnancy
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:预防
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:日常护理
|
Green prescription with support from facilitator
|
|
实验性的:Lifestyle counseling
Green prescription with facilitator support
|
Green prescription with support from facilitator
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
HbA1c Progression to diabetes
大体时间:6 months
|
6 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:Martin Dawes、UBC
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
2012年7月1日
初级完成 (实际的)
2013年10月1日
研究注册日期
首次提交
2012年4月30日
首先提交符合 QC 标准的
2012年5月1日
首次发布 (估计)
2012年5月2日
研究记录更新
最后更新发布 (估计)
2014年3月5日
上次提交的符合 QC 标准的更新
2014年3月4日
最后验证
2014年3月1日
更多信息
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.