Effectiveness of a Group Intervention to Promote Health Through a Clinical Trial
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|ClinicalTrials.gov Identifier: NCT01440738|
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : June 18, 2019
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.
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|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|
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
- Health Related Quality of life [ Time Frame: 0, 3, 6 and 12 months ]Health Ralated Quality of Life (EuroQol 5D-3L)
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
|Institut català de la salut|
|Barcelona, Spain, 08006|
|Principal Investigator:||Maria Antonia Campo Osaba||IDIAP Jordi Gol|