On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients (VIVIR-MEJOR)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle on-line intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Internet intervention, Cardiovascular disease, Hypertension, Lifestyle intervention, Weight loss treatment
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle on-line intervention
Arm Description
The self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules.
Outcomes
Primary Outcome Measures
Changes in blood pressure levels at 6 and 12 months
(arterial brachial systolic and diastolic pressure, determined by Omron®; in millimeters of mercury)
Secondary Outcome Measures
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.
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.
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).
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
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.
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®);
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 );
Body Mass Index
(Body Mass Index = kilograms / height 2(meters).
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.
Full Information
NCT ID
NCT02445833
First Posted
April 22, 2015
Last Updated
May 23, 2017
Sponsor
Universitat Jaume I
Collaborators
University of Valencia, Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT02445833
Brief Title
On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients
Acronym
VIVIR-MEJOR
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I
Collaborators
University of Valencia, Cardenal Herrera University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Internet intervention, Cardiovascular disease, Hypertension, Lifestyle intervention, Weight loss treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle on-line intervention
Arm Type
Experimental
Arm Description
The self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle on-line intervention
Other Intervention Name(s)
VIVIR MEJOR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in blood pressure levels at 6 and 12 months
Description
(arterial brachial systolic and diastolic pressure, determined by Omron®; in millimeters of mercury)
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Secondary Outcome Measure Information:
Title
Quality of life variables with the Quality of life-QLI
Description
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.
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Title
Food Intake style with Dutch Eating Behaviour Questionnaire
Description
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.
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Title
Pyshical activity with the International Physical Activity Questionnaire - IPAQ - short
Description
- 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).
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Title
Self-efficacy with the Self-Efficacy Questionnaire General
Description
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
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Title
Regulation of behavior in physical exercise and eating habits with BREQ-2
Description
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.
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Title
Blood preasure
Description
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®);
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Title
Estimation Indirect fitness level / activity energy expenditure using portable accelerometer (Actigraph GT1M®)
Description
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 );
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Title
Body Mass Index
Description
(Body Mass Index = kilograms / height 2(meters).
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Title
Satisfaction with treatment
Description
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.
Time Frame
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26239241
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.
Results Reference
derived
Learn more about this trial
On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients
We'll reach out to this number within 24 hrs