Group Motivational Intervention in Overweight/Obese Patients

Obesity Clinical Trial

— IMOAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01006213
• Other study ID #: PI070087
• Status: Recruiting
• Phase: N/A
• First received: October 30, 2009
• Last updated: October 30, 2009
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: October 2009
• Source: Jordi Gol i Gurina Foundation
• Contact: JUAN JOSE RODRIGUEZ-CRISTOBAL, DR
• Phone: 0034932611672
• Email: 21002jrc[@]comb.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2010
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

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)

Locations

Country	Name	City	State
Spain	Abs Florida Sur	Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	If a group of motivational intervention, together with current clinical practice, is more efficient than the latter in the treatment of overweight and obesity		two years	No
Secondary	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)		two years	No