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

NCT01440738 | Completed DMC

• 1 other identifier: PI09/90746
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

general population

Outcome Measures

Primary Outcomes (1)

• Health Related Quality of life

  Health Ralated Quality of Life (EuroQol 5D-3L)

  0, 3, 6 and 12 months

Study Arms (2)

health workshops

EXPERIMENTAL

Health promotion group intervention

Behavioral: health workshops

comparison group

NO INTERVENTION

usual care

Interventions

health workshops 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

health workshops

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General population between 18 and 65 years who consent to participate.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Catalan Institute of Health: collaborator

Study Sites (1)

Institut català de la salut

Barcelona, 08006, Spain

Location

Related Publications (1)

• 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.

  PMID: 22429693 BACKGROUND

Related Links

• Related Info

Study Officials

• Maria Antonia Campo Osaba

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: September 26, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: September 1, 2012
• Last Updated: June 18, 2019

Record last verified: 2011-09

Locations

ES (1)