Group Motivational Intervention in Overweight/Obese Patients.

Not Applicable

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)

• Registration Number: NCT01202292
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-10
• Study First Submitted: 2010-05-31
• Status Verified: 2010-09
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Last Update Submitted: 2010-09-30
• Last Update Posted: 2010-10-01
• Study Completion: 2010-12

Recruitment & Eligibility

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

Inclusion Criteria

1. Overweight (BMI>25) and obese (BMI>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
2. Aged between 30 and 70 years
3. Agreement to participate in the study

Exclusion Criteria

1. Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
2. Patients with secondary obesity (hypothyroidism, Cushing's disease, etc)
3. Patients with severe sensorial disorders capable of interfering with the motivational intervention (severe, uncorrected deafness, severe visual deficit, etc).
4. Patients with serious psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Behavioral (e.g., Psychotherapy, Lifestyle Counseling)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

ABS Florida Sud; 🇪🇸 L'Hospitalet del Llobregat, Barcelona, Spain