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

23 maggio 2017 aggiornato da: Universitat Jaume I

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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

106

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Lifestyle on-line intervention
The self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules.
Comportamentale: 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.
Altri nomi:
  • VIVIR MEJOR

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in blood pressure levels at 6 and 12 months
Lasso di tempo: 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)
It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of life variables with the Quality of life-QLI
Lasso di tempo: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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
Lasso di tempo: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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
Lasso di tempo: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
- 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
Lasso di tempo: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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
Lasso di tempo: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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
Lasso di tempo: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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®)
Lasso di tempo: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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
Lasso di tempo: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
(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
Lasso di tempo: It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.
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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universitat Jaume I

Collaboratori

Cardenal Herrera University
University of Valencia

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2014

Completamento primario (Effettivo)

1 gennaio 2017

Completamento dello studio (Effettivo)

1 aprile 2017

Date di iscrizione allo studio

Primo inviato

22 aprile 2015

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2015

Primo Inserito (Stima)

15 maggio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Vivir mejor

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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