On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients (VIVIR-MEJOR)
2017年5月23日 更新者：Universitat Jaume I
Design, Development And Validation Of A On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive And Risk For Diabetes Mellitus People With Overweight And Type I Obesity
Efficacy of an Internet-based self-guided intervention for promoting healthy habits and weight loss in hypertensive people with overweight and obesity: A Randomized Controlled Trial
研究概览
详细说明
The prevalence of overweight and obesity is on the rise worldwide with severe physical and psychosocial consequences.
Hypertension is one of the comorbidities associated with obesity.
Changes in lifestyles through eating behavior and physical activity level are the critical components in the prevention and treatment for hypertension and obesity.
Data from several studies indicate that the usual procedures to promote these healthy habits in health services are inadequate.
ICTs has been demonstrated as an effective tool for implementation of psychological interventions focused on this type of population.
This study aims to describe a totally self-applied online program (¨Vivir Mejor¨) to promote healthy lifestyles (eating behavior and physical activity) for obese participants with hypertension.
Participants (BMI=25-35) will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group "Vivir Mejor" and control group (treatment as usual).
"Vivir Mejor" program is composed by 9 modules aimed for promoting healthy eating habits and increase physical activity.
Modules will be sent via Internet periodically.
After 6 months, a follow-up testing phase and a tracking module will be set.
The outcomes variables will include anthropometric data, changes in eating behavior and physical performance and cardiovascular variables.
研究类型
介入性
注册 (实际的)
106
阶段
- 不适用
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:
- Overweight or obese grade I (BMI> 25 and <35)
- Age between 18-65 years
- Being in clinical medical treatment for prevention of metabolic syndrome or Cardiac complications
- Having internet access.
Exclusion Criteria:
- No Internet access; Taking more than 3 antihypertensive drugs
- Have Diabetes diagnosis; Meet the DSM-IV-TR of Eating Disorder
- Submit a serious psychological disorder diagnosed (psychosis, bipolar disorder, major depressive disorder, substance abuse)
- Have a disability which prevents or hinders the exercise and physical activity
- Be receiving any treatment for weight loss in another center.
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Lifestyle on-line intervention
The self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules.
|
The self-applied on-line intervention will comprise a behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating habits and physical activity in participants (Themes: 1.motivation for change; 2. nutrition and physical activity education; 3. barriers to change, healthy eating principles and how to be active; 4. Influence of thoughts; 5. Emotional eating and self-control; 6. Problem solving; 7. Body image and assertiveness; 8. Relapse prevention)..The program will be established as follows: The first day the participant log in the website where can access the processing modules.
A web page was developed specially for this study.
其他名称：
|
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 |
|---|---|---|
|
Changes in blood pressure levels at 6 and 12 months
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
(arterial brachial systolic and diastolic pressure, determined by Omron®; in millimeters of mercury)
|
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life variables with the Quality of life-QLI
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
Quality of life-QLI (Mezzich, Cohen and Ruiperez 1999; Spanish version of Mezzich et al, 2000): It includes 10 items, with multiple-choice Likert response format, consisting of a scale of 1 to 10. Evaluates 10 areas: physical, psychological, self-care and independent functioning welfare, occupational functioning , interpersonal functioning, social-emotional support, community and support services, personal fulfillment, spiritual fulfillment, overall perception of quality of life.
|
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
|
Food Intake style with Dutch Eating Behaviour Questionnaire
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
DEBQ- Dutch Eating Behavior Questionnaire (Van Strien et al, 1986).
Translated into Spanish by Baños, 2011): Evaluates styles posing contribute intake or attenuate the development of overweight.
It is composed of 33 items, with Likert scale of 5 points.
|
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
|
Pyshical activity with the International Physical Activity Questionnaire - IPAQ - short
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
- International Physical Activity Questionnaire - IPAQ - short (Booth, 2000.):
Self-report of 7 items that collects information about PA and sedentary behavior of people in four areas: activity at work, when traveling, at home and during leisure time (leisure).
The IPAQ addresses the number of days and minutes for performing physical activities such as leisure-time occupations, locomotion and housework activities.
The score is derived from the number of days, hours and minutes employed therein (Carral & Perez, 2011).
|
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
|
Self-efficacy with the Self-Efficacy Questionnaire General
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
GSES-12 Self-Efficacy Questionnaire General (Baessler & Schwarcer, 1996): Self-report scale consisting of 10 items with Likert scales of 4 points.
It was designed to assess the overall efficacy and evaluates the stable sense of personal competence to effectively manage a variety of stressful situations
|
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
|
Regulation of behavior in physical exercise and eating habits with BREQ-2
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
BREQ-2 - Scale regulation of behavior in physical exercise and eating habits (Markland & Tobin, 2004.
Validated to the Spanish context by Moreno, Cervellò & Martinez Camacho, 2006): The original questionnaire was developed to measure external regulation, introjected, identified and intrinsic motivation.
The BREQ-2 scale consists of 19 items, compared with 15 of the original scale, measuring stages of the continuum of self-determination.
An adaptation of this scale also be conducted to assess motivation to change eating habits.
|
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
|
Blood preasure
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
Pressure Arterial brachial systolic and diastolic (determined by Omron®; in millimeters of mercury), Central systolic and diastolic blood pressure (measured by MOBIL-O-GRAPH®; augmentation index), speed of the pulse wave; Afectación By vascular arterial stiffness parameters: speed of the pulse wave (PWV) and analysis of the pulse wave, augmentation index and central arterial pressure (measured by oscillometric brachial (MOBIL-O-GRAPH®) and carotid distensibility ultrasound (ESAOTE®);
|
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
|
Estimation Indirect fitness level / activity energy expenditure using portable accelerometer (Actigraph GT1M®)
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
To assess cardiorespiratory endurance test subjects performed the 6MWT (Test of 6-minute walk): cardiorespiratory functional test consists of measuring the maximum distance you can go walking a subject for 6 minutes.
In each participant the routes meters, average heart rate (MHR) during test development (monitored through digital heart rate monitor Polar 610si®) and heart rate recovery phase to post-minute effort was recorded (FCR1 );
|
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
|
Body Mass Index
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
(Body Mass Index = kilograms / height 2(meters).
|
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
|
Satisfaction with treatment
大体时间：It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
|
6-item scale with a 10-point Likert scale.
It evaluates the user's opinion about the program received in terms of satisfaction and usefulness.
|
It will be avaluated before and after a 3 months intervention, and follow up in 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。
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 (实际的)
2014年9月1日
初级完成 (实际的)
2017年1月1日
研究完成 (实际的)
2017年4月1日
研究注册日期
首次提交
2015年4月22日
首先提交符合 QC 标准的
2015年5月12日
首次发布 (估计)
2015年5月15日
研究记录更新
最后更新发布 (实际的)
2017年5月25日
上次提交的符合 QC 标准的更新
2017年5月23日
最后验证
2017年5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.
Lifestyle on-line intervention的临床试验
-
University of HawaiiNational Heart, Lung, and Blood Institute (NHLBI); National Association of Pasifika Organizations 和其他合作者邀请报名血脂异常 | 糖尿病前期 | 2 型糖尿病 (T2DM) | 高血压 (HTN) | 超重（BMI > 25） | 减肥试验 | 心脏代谢状况美国