Group Motivational Intervention in Overweight/Obese Patients

Study Overview
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Brief Summary
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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: 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.

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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Motivational intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling vs motivational intervention<br> | Behavioral: Motivational intervention<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivational Intervention