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

NCT ID: NCT02445833

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-04-30

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle on-line intervention

The self-applied on-line intervention will received acces to the web and the "Vivir mejor" modules.

Group Type: EXPERIMENTAL

Lifestyle on-line intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

VIVIR MEJOR

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: collaborator

Cardenal Herrera University

OTHER

Sponsor Role: collaborator

Universitat Jaume I

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 26239241 (View on PubMed)

Other Identifiers

Vivir mejor

Identifier Type: -

Identifier Source: org_study_id