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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 主要终点
- Changes in blood pressure levels at 6 and 12 months
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in blood pressure levels at 6 and 12 months
时间窗: 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)
次要结局
- Pyshical activity with the International Physical Activity Questionnaire - IPAQ - short(It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.)
- Quality of life variables with the Quality of life-QLI(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(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(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(It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.)
- Blood preasure(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®)(It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.)
- Body Mass Index(It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.)
- Satisfaction with treatment(It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.)