Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor) (CapiCor)
Effectiveness of a Physical Activity and Diet Program, Coordinated Between Primary Care and Mental Health, to Modify Cardiovascular Risk Factors in Patients With Schizophrenia or Bipolar Disorder (CapiCor)
The aim is to evaluate the effectiveness of an intervention based on a program of physical activity and diet coordinated between primary care teams (PCT) and Mental Health Centres (MHC) to modify the weekly physical activity (PA) amount, body mass index (BMI) and waist circumference in patients with severe mental disorder diagnoses.
To assess changes in cardiovascular risk, quality of life and lifestyles, secondarily.
Methods: A randomized clinical trial with a control group, of one year of follow-up, carried out in four MHC Barcelona and Santa Coloma, and PCT of reference.
The investigators studied patients aged 18 - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with antipsychotic medication and a low level of PA. 240 patients will be selected in each group (difference to be detected in the BMI:> 1.89 kg/m2; common SD: 6.2, 30% loss).
Intervention: group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (8 sessions in the first 8 weeks) by nurses and specialists in PA.
Key measurements: level of PA (IPAQ questionnaire), physical examinations: BMI, waist circumference, blood pressure, cardiovascular risk, quality of life (SF-36), smoking habits, dietary habits (PREDIMED questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose.
Evaluations will be masked and conducted at 0, 3, 6 and 12 months.
Analysis of variance for repeated measures to adjust for differences attributable to the effect of the intervention for potential confounders: pharmacological treatment, care level of intervention and mental state.
研究概览
研究类型
介入性
注册 (实际的)
332
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
-
-
-
Barcelona、西班牙、08007
- Jordi Gol i Gurina Foundation
-
-
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 至 65年 (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:
- age between 18 and 65 years old,
- understand Catalan or Spanish
- will be located for at least twelve months.
- Psychiatric disorders with ICD-10 diagnosis codes: F20*, F31* and F25*.
- Taking an antipsychotic drug at, a least, three months
- Low physical activity level
Exclusion Criteria:
- Active addiction to psychoactive drugs, except tobacco.
- Pregnancy
- Diseases that doesn't allow physical activity
- Psychotic acute exacerbation in the last month
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Physical and diet educational group
group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks), carried out by mental health nurses.
|
educational group of: physical activity program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks, carried out by mental health nurses.
|
|
无干预:Usual clinical care
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in weekly level of physical activity (IPAQ questionnaire),
大体时间:: the outcome measure is studied at 3, 6 and 12 months
|
: the outcome measure is studied at 3, 6 and 12 months
|
|
Body mass index (kg/m²)
大体时间:: the outcome measure is studied at 3, 6 and 12 months
|
: the outcome measure is studied at 3, 6 and 12 months
|
|
waist circumference (cm)
大体时间:: the outcome measure is studied at 3, 6 and 12 months
|
: the outcome measure is studied at 3, 6 and 12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
blood pressure (mm hg)
大体时间:the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
|
|
cardiovascular risk with the Regicor coronary risk to 10 years
大体时间:the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
|
|
Quality of life (SF-36 questionnaire)
大体时间:the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
|
|
Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.
大体时间:the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
|
|
Dietary habits (PREDIMED questionnaire)
大体时间:the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
|
|
Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.
大体时间:the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Clinical Global Impression, CGI
大体时间:the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
|
|
BPRS (Brief Psychiatric Rating Scale)
大体时间:the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 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:MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH、Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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。
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6月1日
初级完成 (实际的)
2015年3月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2012年11月14日
首先提交符合 QC 标准的
2012年11月19日
首次发布 (估计)
2012年11月20日
研究记录更新
最后更新发布 (估计)
2016年9月1日
上次提交的符合 QC 标准的更新
2016年8月31日
最后验证
2016年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PI11/01861
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.