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

Sponsor
Jordi Gol i Gurina Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT01440738
Collaborator
Catalan Institute of Health (Other)
170
1
2
12
14.1

Study Details

Study Description

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
  • Behavioral: health workshops
N/A

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.

Study Design

Study Type:
Interventional
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 :
Sep 1, 2011
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Health Related Quality of life [0, 3, 6 and 12 months]

    Health Ralated Quality of Life (EuroQol 5D-3L)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Institut català de la salut Barcelona Spain 08006

Sponsors and Collaborators

  • Jordi Gol i Gurina Foundation
  • Catalan Institute of Health

Investigators

  • Principal Investigator: Maria Antonia Campo Osaba, IDIAP Jordi Gol

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01440738
Other Study ID Numbers:
  • PI09/90746
First Posted:
Sep 26, 2011
Last Update Posted:
Jun 18, 2019
Last Verified:
Sep 1, 2011
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Jordi Gol i Gurina Foundation

Study Results

No Results Posted as of Jun 18, 2019