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Group Motivational Intervention in Overweight/Obese Patients (IMOAP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01006213
First Posted: November 2, 2009
Last Update Posted: November 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Instituto de Salud Carlos III
Information provided by:
Jordi Gol i Gurina Foundation
  Purpose

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.


Condition Intervention
Overweight Obesity Behavioral: Motivational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area (IMOAP)

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1200
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01006213


Contacts
Contact: JUAN JOSE RODRIGUEZ-CRISTOBAL, DR 0034932611672 21002jrc@comb.es

Locations
Spain
Abs Florida Sur Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08905
Contact: JUAN JOSE RODRIGUEZ-CRISTOBAL, DR    0034932611672    21002jrc@comb.es   
Principal Investigator: JUAN JOSE RODRIGUEZ-CRISTOBAL, DR         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Instituto de Salud Carlos III