Clinical trial NCT02445833: On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Internet intervention
Cardiovascular disease
Hypertension
Lifestyle intervention
Weight loss treatment
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: University of Valencia
name: Cardenal Herrera University
First posted: 2015-05-15
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in blood pressure levels at 6 and 12 months
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Secondary outcomes:
measure: Quality of life variables with the Quality of life-QLI
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
measure: Food Intake style with Dutch Eating Behaviour Questionnaire
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
measure: Pyshical activity with the International Physical Activity Questionnaire - IPAQ - short
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
measure: Self-efficacy with the Self-Efficacy Questionnaire General
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
measure: Regulation of behavior in physical exercise and eating habits with BREQ-2
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
measure: Blood preasure
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
measure: Estimation Indirect fitness level / activity energy expenditure using portable accelerometer (Actigraph GT1M®)
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
measure: Body Mass Index
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
measure: Satisfaction with treatment
timeFrame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Other outcomes:
Locations:
Study officials:
References:
citation: Banos RM, Mensorio MS, Cebolla A, Rodilla E, Palomar G, Lison J, Botella C. An internet-based self-administered intervention for promoting healthy habits and weight loss in hypertensive people who are overweight or obese: a randomized controlled trial. BMC Cardiovasc Disord. 2015 Aug 4;15:83. doi: 10.1186/s12872-015-0078-1.