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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: health workshops

• Registration Number: NCT01440738
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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).

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 Timeline

• Study First Submitted: 2010-06-21
• Status Verified: 2011-09
• Study Start: 2011-09
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Primary Completion: 2011-10
• Study Completion: 2012-09
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
health workshops	health workshops	Health promotion group intervention

Primary Outcome Measures

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

Trial Locations

Locations (1)

Institut català de la salut; 🇪🇸 Barcelona, Spain