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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01202292
• Other study ID #: PI 070087
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2010
• Last updated: September 30, 2010
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: Jordi Gol i Gurina Foundation
• Contact: Juan Jose Rodriguez-Cristóbal, Dr
• Phone: 0034934471080
• Email: 21002jrc[@]comb.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
Group motivational intervention consist in expert psychologist 32 monthly sessions (group intervention) on top of the diet plus exercise

Locations

Country	Name	City	State
Spain	ABS Florida Sud	L'Hospitalet del Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Rodríguez Cristóbal JJ, Panisello Royo JM, Alonso-Villaverde Grote C, Pérez Santos JM, Muñoz Lloret A, Rodríguez Cortés F, Travé Mercadé P, Benavides Márquez F, Martí de la Morena P, González Burgillos MJ, Delclós Baulies M, Bleda Fernández D, Quillama Torres E; IMOAP Group. Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area. BMC Fam Pract. 2010 Mar 18;11:23. doi: 10.1186/1471-2296-11-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No