NCT02445833

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

April 22, 2015

Last Update Submit

May 23, 2017

Conditions

Obesity

Keywords

ObesityInternet interventionCardiovascular diseaseHypertensionLifestyle interventionWeight loss treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Quality of life variables with the Quality of life-QLI

    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

    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

    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

    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

    It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.

  • +4 more secondary outcomes

Study Arms (1)

Lifestyle on-line intervention

EXPERIMENTAL

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

Behavioral: Lifestyle on-line intervention

Interventions

Lifestyle on-line interventionBEHAVIORAL

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.

Also known as: VIVIR MEJOR
Lifestyle on-line intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26239241DERIVED

MeSH Terms

Conditions

ObesityCardiovascular DiseasesHypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 15, 2015

Study Start

September 1, 2014

Primary Completion

January 1, 2017

Study Completion

April 1, 2017

Last Updated

May 25, 2017

Record last verified: 2017-05