ObesityVIVIR-MEJORNCT02445833
On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients
A study testing Lifestyle on-line intervention in people with Obesity, run by Universitat Jaume I.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle on-line intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
Read the 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.
- Conditions
- Obesity
- Being tested
- Lifestyle on-line intervention
- Keywords
- Obesity, Internet intervention, Cardiovascular disease, Hypertension, Lifestyle intervention, Weight loss treatment
- Medical subject headings
- Obesity, Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle on-line interventionBehavioural
Also called VIVIR MEJOR
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle on-line intervention | Experimental | The self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules. Receives: Behavioral: Lifestyle on-line intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure levels at 6 and 12 months
(arterial brachial systolic and diastolic pressure, determined by Omron®; in millimeters of mercury)
Measured: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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®);
Measured: 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 );
Measured: 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).
Measured: 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.
Measured: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startSep 2014
- Primary completionJan 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia, Cardenal Herrera University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445833
- Sponsor's protocol ID
- Vivir mejor
- Acronym
- VIVIR-MEJOR
- Status last verified
- May 2017
- First submitted
- 22 Apr 2015
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26239241
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02445833
- Acronym / sponsor ID
- VIVIR-MEJOR / Vivir mejor
- Conditions
- Obesity
- Keywords
- Obesity, Internet intervention, Cardiovascular disease, Hypertension, Lifestyle intervention, Weight loss treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- University of Valencia, Cardenal Herrera University
- Study start
- Sep 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle on-line intervention | Experimental | Behavioral: Lifestyle on-line interventionThe self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle on-line interventionAlso: VIVIR MEJORThe 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. | Behavioural | Lifestyle on-line intervention |
Primary outcome
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)
9 secondary outcomes
Quality of life variables with the Quality of life-QLI
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Blood preasure
Time frame: 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®)
Time frame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Body Mass Index
Time frame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Satisfaction with treatment
Time frame: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Derived from this study: PubMed 26239241Banos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle on-line intervention in people with Obesity, run by Universitat Jaume I.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02445833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.