Group Motivational Intervention in Overweight/Obese Patients.

Study Overview
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Brief Summary
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The overall goal of IMOAP study is to assess whether the efficacy of the healthcare professionals' usual practices, together with a motivational group intervention (delivered by a nurse trained by an expert psychologist), is more effective than an isolated traditional intervention on weight loss and its maintenance in overweight and obese patients. Furthermore, the study will evaluate whether this result has a positive impact on quality of life, changes in eating habits, and a reduction in the associated cardiovascular risk factors and overall cardiovascular risk.

Detailed Description
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The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study in two geographically separated groups, one of which would receive the group motivational intervention, and the other one would receive the usual follow up.

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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)


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 (severe, uncorrected deafness, severe visual deficit, etc). 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: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br> | Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)<br>* Group motivational intervention consist in expert psychologist 32 monthly sessions (group intervention) on top of the diet plus exercise<br>* Other names: Control group receives the usual follow up: diet, exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether a group motivational intervention, is more efficient than the latter in the treatment of overweight and obesity, for initial weight loss and essentially to achieve sustained normalisation of the weight achieved. |  | 26 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe whether this intervention is more effective for reducing cardiovascular risk factors associated to overweight and obesity, and in the overall cardiovascular risk in these patients. |  | 26 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity, motivational intervention