Overview

This trial is active, not recruiting.

Condition obesity
Treatment lifestyle on-line intervention
Sponsor Universitat Jaume I
Collaborator University of Valencia
Start date September 2014
End date July 2015
Trial size 150 participants
Trial identifier NCT02445833, Vivir mejor

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules.
lifestyle on-line intervention 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.

Primary Outcomes

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.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Universitat Jaume I.