On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445833
• Other study ID #: Vivir mejor
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: May 23, 2017
• Start date: September 2014
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Universitat Jaume I
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universitat Jaume I	Cardenal Herrera University, University of Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.