Group Motivational Intervention in Overweight/Obese Patients. (IMOAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01202292
Recruitment Status : Unknown
Verified September 2010 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Recruiting
First Posted : September 15, 2010
Last Update Posted : October 1, 2010
Information provided by:
Jordi Gol i Gurina Foundation

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area.
Study Start Date : January 2008
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: Lifestyle counseling 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
Other Name: Control group receives the usual follow up: diet, exercise

Primary Outcome Measures :
  1. 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. [ Time Frame: 26 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 26 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01202292

Contact: Juan Jose Rodriguez-Cristóbal, Dr 0034934471080

ABS Florida Sud Recruiting
L'Hospitalet del Llobregat, Barcelona, Spain, 08095
Contact: Juan José Rodriguez-Cristóbal, Dr    934471080   
Principal Investigator: Juan José Rodriguez Cristóbal, Dr         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Principal Investigator: Juan José Roodriguez-Cristóbal, Dr Catalan Institute of Health

Responsible Party: Juan José Rodriguez Cristóbal, ABS FLORIDA SUR Identifier: NCT01202292     History of Changes
Other Study ID Numbers: PI 070087
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: October 1, 2010
Last Verified: September 2010

Keywords provided by Jordi Gol i Gurina Foundation:
motivational intervention

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms