HEalth Promotion Intervention in MEntal Health Care (HEPIMEC)
2014年12月4日 更新者：University Ghent
Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders
Overweight and obesity have become a serious global public health problem and the prevalence of these conditions is even higher among persons with mental disorders, compared with the general population. Overweight and obesity are partially associated with sedentary lifestyles and unhealthy eating habits.
The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and eating habits in persons with mental disorders.
The study hypothesis is that between baseline and the end of the intervention, and after a 6-month follow up period, significant differences in the primary and secondary outcomes between the intervention and control group will be identified. The investigators also hypothesize that the health promotion intervention will be cost-effective.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
742
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
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Antwerpen、比利时
- Beschut Wonen Antwerpen
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Antwerpen、比利时
- Beschut Wonen Min
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Beernem、比利时
- Beschut Wonen Beernem
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Beigem、比利时
- Beschut Wonen De Raster
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Blankenberge、比利时
- Beschut Wonen Oostkust
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Brugge、比利时
- Beschut Wonen Brugge
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Diest、比利时
- Beschut Wonen De Linde
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Eeklo、比利时
- Beschut Wonen De Wende
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Gent、比利时
- Beschut Wonen Centrum Onderweg
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Gent、比利时
- Beschut Wonen Delta Wonen
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Gent、比利时
- Beschut Wonen Domos
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Gent、比利时
- Beschut Wonen Zagan
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Hasselt、比利时
- Beschut Wonen Basis
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Heusden-Zolder、比利时
- Beschut Wonen West-Limburg
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Izegem、比利时
- Beschut Wonen regio Izegem
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Kortrijk、比利时
- Beschut Wonen De Bolster
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Leuven、比利时
- Beschut Wonen De Hulster
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Maasmechelen、比利时
- Beschut Wonen Het Veer
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Menen、比利时
- Beschut Wonen Eigen Woonst
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Oostende、比利时
- Beschut Wonen Oostende
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Overpelt、比利时
- Beschut Wonen Noord-Limburg
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Roeselare、比利时
- Beschut Wonen Roeselare-Tielt
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Sint-Niklaas、比利时
- Beschut Wonen Pro Mente
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Sint-Niklaas、比利时
- Beschut Wonen Waasland
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Veurne、比利时
- Beschut Wonen Veurne-Diksmuide
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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:
- 18 years of age or older
- living in sheltered housing
- diagnosed according to the Diagnostic and Statistical Manual of mental disorders (DSM-IV manual)
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：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：health promotion program
Psycho education and behavioural group sessions and supervised walking sessions will be performed.
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10 psycho educational and behavioural group sessions on topics like the Food Triangle, healthy eating, the importance of physical activity, healthy eating on a limited budget, implementing physical activity into the daily life, the influence of advertisements...
A weekly supervised walking session (30 minutes) in a 10-week period.
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无干预：Control group
No intervention will be performed in this control group.
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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 |
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change in body weight 10 weeks post-intervention
大体时间：after 10 weeks
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The primary outcome of the study consists of changes in body weight between baseline and 10-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
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after 10 weeks
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change in body weight 26 weeks post-intervention
大体时间：after 26 weeks
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The primary outcome of the study consists of changes in body weight between baseline and 26-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
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after 26 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Body Mass Index 10 weeks post-intervention
大体时间：after 10 weeks
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Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²)
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after 10 weeks
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Body Mass Index, 26 weeks post-intervention
大体时间：after 26 weeks
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Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²).
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after 26 weeks
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Waist circumference, 10 weeks post-intervention
大体时间：After 10 weeks
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Waist circumference, assessed by using a tape measure.
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After 10 weeks
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Waist circumference, 26 weeks post-intervention
大体时间：After 26 weeks
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Waist circumference, assessed by using a tape measure.
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After 26 weeks
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Quality of Life, 10 weeks post-intervention
大体时间：After 10 weeks
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Quality of life, assessed by using the SF-36 Health Survey.
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After 10 weeks
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Quality of Life, 26 weeks post-intervention
大体时间：After 26 weeks
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Quality of life, assessed by using the SF-36 Health Survey.
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After 26 weeks
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Levels of physical activity, 10 weeks post-intervention
大体时间：After 10 weeks
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Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
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After 10 weeks
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Levels of physical activity, 26 weeks post-intervention
大体时间：After 26 weeks
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Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
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After 26 weeks
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Eating habits, 10 weeks post-intervention
大体时间：After 10 weeks
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Eating habits, assessed by using a 24-hour dietary recall.
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After 10 weeks
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Eating habits, 26 weeks post-intervention
大体时间：After 26 weeks
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Eating habits, assessed by using a 24-hour dietary recall.
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After 26 weeks
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Psychiatric symptom severity, 10 weeks post-intervention
大体时间：After 10 weeks
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Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
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After 10 weeks
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Psychiatric symptom severity, 26 weeks post-intervention
大体时间：After 26 weeks
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Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
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After 26 weeks
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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：Lieven Annemans, Ph.D., Professor、University Ghent
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Verhaeghe N, Clays E, Vereecken C, De Maeseneer J, Maes L, Van Heeringen C, De Bacquer D, Annemans L. Health promotion in individuals with mental disorders: a cluster preference randomized controlled trial. BMC Public Health. 2013 Jul 15;13:657. doi: 10.1186/1471-2458-13-657.
- Verhaeghe N, De Maeseneer J, Maes L, Van Heeringen C, Bogaert V, Clays E, De Bacquer D, Annemans L. Health promotion intervention in mental health care: design and baseline findings of a cluster preference randomized controlled trial. BMC Public Health. 2012 Jun 13;12:431. doi: 10.1186/1471-2458-12-431.
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
2011年1月1日
初级完成 (实际的)
2013年5月1日
研究完成 (实际的)
2013年5月1日
研究注册日期
首次提交
2011年4月14日
首先提交符合 QC 标准的
2011年4月15日
首次发布 (估计)
2011年4月18日
研究记录更新
最后更新发布 (估计)
2014年12月5日
上次提交的符合 QC 标准的更新
2014年12月4日
最后验证
2014年12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.