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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Jordi Gol i Gurina Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Catalan Institute of Health
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01440738
First received: June 21, 2010
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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 Intervention
Healthy
Behavioral: health workshops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Group Intervention to Promote Health Through a Clinical Trial

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 0, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 376
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: health workshops 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440738

Contacts
Contact: Maria Antonia Campo-Osaba, Masters +34619591906 macampo@gencat.cat

Locations
Spain
Institut català de la salut Recruiting
Barcelona, Spain, 08006
Contact: Maria Antonia Campo-Osaba, Masters    +34619591906    macampo@gencat.cat   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Catalan Institute of Health
Investigators
Principal Investigator: Maria Antonia Campo Osaba IDIAP Jordi Gol
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01440738     History of Changes
Other Study ID Numbers: PI09/90746
Study First Received: June 21, 2010
Last Updated: September 23, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Jordi Gol i Gurina Foundation:
general population

ClinicalTrials.gov processed this record on September 22, 2014