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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440738
• Other study ID #: PI09/90746
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2011
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

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

Locations

Country	Name	City	State
Spain	Institut català de la salut	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Catalan Institute of Health

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Campo Osaba MA, Del Val JL, Lapena C, Laguna V, García A, Lozano O, Martín Z, Rodriguez R, Borrás 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of life	Health Ralated Quality of Life (EuroQol 5D-3L)	0, 3, 6 and 12 months

External Links

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