Group Motivational Intervention in Overweight/Obese Patients (IMOAP)

October 30, 2009 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area (IMOAP)

Overall mortality, such as that caused by cardiovascular disease, increases as weight increases. In the Framingham Study, it was shown that obesity is a cardiovascular risk factor independent of other risk factors such as type 2 diabetes mellitus, dyslipidemia and smoking.

Objectives:

  1. To determine whether a group motivational intervention is more effective than the standard intervention for treatment of overweight and obesity and most importantly to maintain the attained weight loss on a permanent basis.
  2. To assess whether this intervention is more effective than reducing cardiovascular risk factors (lipid profile, apo B-100, apo A-1, fibrinogen, C-reactive protein, hypertension, diabetes mellitus) associated with overweight and obesity, and the overall cardiovascular risk in these patients.

Design: Randomized, multicenter, interventional clinical trial in patients with overweight and obesity. Randomized assignment of the intervention by Basic Health Areas (BHAs). Two groups will be established in geographically separate areas, one of which will receive the group motivational intervention (intervention group) and the other will receive standard follow-up (control group). BHAs located in the same building will be assigned the same group (control or intervention) to avoid potential contamination. hypertensive treatment or with a diagnosis of hypertension in their clinical history.

Study Scope: Primary care. The study will be conducted in 24 BHAs of Hospitalet de Llobregat and Barcelona during 26months follow-up period. Haematic analyses will be in the carried out at the reference laboratory.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08905
        • Recruiting
        • Abs Florida Sur
        • Contact:
          • JUAN JOSE RODRIGUEZ-CRISTOBAL, DR
          • Phone Number: 0034932611672
          • Email: 21002jrc@comb.es
        • Principal Investigator:
          • JUAN JOSE RODRIGUEZ-CRISTOBAL, DR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight (BMI>25) and obese (BMI>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
  • Aged between 30 and 70 years
  • Agreement to participate in the study

Exclusion Criteria:

  • Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
  • Patients with secondary obesity (hypothyroidism, Cushing's disease, etc).
  • Patients with severe sensorial disorders capable of interfering with the motivational intervention
  • Patients with serious psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counseling vs motivational intervention
Behavioral: Motivational intervention
Two groups will be established in geographically separate areas, one of which will receive the group motivational intervention (intervention group) and the other will receive standard follow-up (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
If a group of motivational intervention, together with current clinical practice, is more efficient than the latter in the treatment of overweight and obesity
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Observe whether this intervention is more effective for reducing cardiovascular risk factors (lipid profile, apo B-100, apo A-1, fibrinogen, reactive protein C, hypertension, diabetes mellitus)
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

January 1, 2008

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

November 1, 2009

Last Update Submitted That Met QC Criteria

October 30, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI070087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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