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

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: health workshops
    • Health promotion group intervention
  • No Intervention: comparison group
    • usual care

Clinical Trial Outcome Measures

Primary Measures

  • Health Related Quality of life
    • Time Frame: 0, 3, 6 and 12 months
    • Health Ralated Quality of Life (EuroQol 5D-3L)

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fundacio d’Investigacio en Atencio Primaria Jordi Gol i Gurina
  • Collaborator
    • Catalan Institute of Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maria Antonia Campo Osaba, Principal Investigator, IDIAP JORDI GOL

References

Campo Osaba MA, Del Val JL, Lapena C, Laguna V, Garcia A, Lozano O, Martin Z, Rodriguez R, Borras E, Orfila F, Tierno MT. The effectiveness of a health promotion with group intervention by clinical trial. Study protocol. BMC Public Health. 2012 Mar 19;12:209. doi: 10.1186/1471-2458-12-209.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.