On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients (VIVIR-MEJOR)

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Lifestyle on-line intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lifestyle on-line intervention; The self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules.

Behavioral: Lifestyle on-line intervention; 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.; Other Names: VIVIR MEJOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure levels at 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life variables with the Quality of life-QLI	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	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	- 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	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	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	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®)	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	(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	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.

Collaborators and Investigators

• Sponsor: Universitat Jaume I
• Collaborators: Cardenal Herrera University; University of Valencia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Obesity; Hypertension; Lifestyle intervention; Internet intervention; Weight loss treatment
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: Vivir mejor