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

NCT ID: NCT01440738

Last Updated: 2019-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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health workshops

Health promotion group intervention

Group Type EXPERIMENTAL

health workshops

Intervention Type BEHAVIORAL

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

comparison group

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Catalan Institute of Health

OTHER_GOV

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Antonia Campo Osaba

Role: PRINCIPAL_INVESTIGATOR

IDIAP JORDI GOL

Locations

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Institut català de la salut

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 22429693 (View on PubMed)

Related Links

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Other Identifiers

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PI09/90746

Identifier Type: -

Identifier Source: org_study_id

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