Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of a Group Intervention to Promote Health Through a Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01440738
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Catalan Institute of Health
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief Summary:

Objectives

Main objective: Assessing the effectiveness of the health workshops, in terms of quality of life.

Secondary: To determine the effectiveness of the health workshops in relation to: Increase knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced diet. Incorporate and maintain regular physical activity; Keep variables related to risk factors (BP, Weight, Cholesterol) within normal limits, reduce cardiovascular risk (RCV). To estimate costs.

Methodology

Design: randomized controlled trial comparing a group of patients who performed the health workshops with a control group with similar characteristics.

Scope of the Study: The study was conducted in 54 health centers of Barcelona city.

Subjects of study: general population between 18 and 65 years who consent to. 188 people with speech (have conducted workshops for health) and 188 people without (not made health workshops. Data Analysis: T- test to compare the differences between quantitative variables or equivalent non-parametric if the distribution of the variable does not meet criteria of normality (Kolmogorov-Smirnov).


Condition or disease Intervention/treatment Phase
Healthy Behavioral: health workshops Not Applicable

Detailed Description:

This is the evaluation of an educational activity to promote health in the general population in order to establish healthy habits and changes in quality of life.

We have designed a proposal for a workshop aimed at general public health which includes biological, psychological, social, cultural and spiritual health related and welfare. It is structured in 12 sessions that will provide tools that facilitate the involvement of people in maintaining their health.

Content of the sessions: Breathing and Snuff. Food. Disposal. Physical activity. Sleep and rest. Appropriate clothing. Hygiene. Avoid danger. Communicate feelings and emotions. Feel useful. Recreational activities. Each participant is given a folder and at the end of each session a summary sheet of the same with the aim that at the end of the course have a reference material.

To validate this material is piloted with the participation of 13 persons. Participants completed the SF36 questionnaire at the beginning and end of the workshop.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Group Intervention to Promote Health Through a Clinical Trial
Study Start Date : September 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: health workshops
Health promotion group intervention
Behavioral: health workshops
health workshops in relation to: Increase knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced diet. Incorporate and maintain regular physical activity

No Intervention: comparison group
usual care



Primary Outcome Measures :
  1. Health Related Quality of life [ Time Frame: 0, 3, 6 and 12 months ]
    Health Ralated Quality of Life (EuroQol 5D-3L)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • General population between 18 and 65 years who consent to participate.

Exclusion Criteria:

  • Difficulty to maintain their participation for 12 months.
  • Difficult to understand and speak Catalan or Spanish language.
  • Severe mental health problems.
  • Other health problems that their participation was not appropriate or fail to follow up planned (terminally ill, serious organic disease).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440738


Locations
Layout table for location information
Spain
Institut català de la salut
Barcelona, Spain, 08006
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Catalan Institute of Health
Investigators
Layout table for investigator information
Principal Investigator: Maria Antonia Campo Osaba IDIAP Jordi Gol
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01440738    
Other Study ID Numbers: PI09/90746
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: September 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jordi Gol i Gurina Foundation:
general population