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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Universitat Jaume I
- Enrollment
- 106
- Primary Endpoint
- Changes in blood pressure levels at 6 and 12 months
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Changes in blood pressure levels at 6 and 12 months
Time Frame: 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)
Secondary Outcomes
- 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.)