Group Motivational Intervention in Overweight/Obese Patients

Not Applicable

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Motivational intervention

• Registration Number: NCT01006213
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-01
• Status Verified: 2009-10
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Last Update Submitted: 2009-10-30
• Study First Posted: 2009-11-01
• Last Update Posted: 2009-11-01
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling vs motivational intervention	Motivational intervention	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Abs Florida Sur; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain