Group Motivational Intervention in Overweight/Obese Patients (IMOAP)
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|ClinicalTrials.gov Identifier: NCT01006213|
Recruitment Status : Unknown
Verified October 2009 by Jordi Gol i Gurina Foundation.
Recruitment status was: Recruiting
First Posted : November 2, 2009
Last Update Posted : November 2, 2009
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.
- 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.
- 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 or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Motivational intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area (IMOAP)|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||January 2008|
|Estimated Study Completion Date :||December 2010|
|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)
- 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 ]
- 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 ]
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
|Contact: JUAN JOSE RODRIGUEZ-CRISTOBAL, DRfirstname.lastname@example.org|
|Abs Florida Sur||Recruiting|
|Hospitalet de Llobregat, Barcelona, Spain, 08905|
|Contact: JUAN JOSE RODRIGUEZ-CRISTOBAL, DR 0034932611672 email@example.com|
|Principal Investigator: JUAN JOSE RODRIGUEZ-CRISTOBAL, DR|