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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Jordi Gol i Gurina Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01202292
First received: May 31, 2010
Last updated: September 30, 2010
Last verified: September 2010

May 31, 2010
September 30, 2010
January 2008
October 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01202292 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Group Motivational Intervention in Overweight/Obese Patients.
Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Overweight
  • Obesity
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
Experimental: Lifestyle counseling
Intervention: Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
December 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact: Juan Jose Rodriguez-Cristóbal, Dr 0034934471080 21002jrc@comb.es
Spain
 
NCT01202292
PI 070087
Yes
Juan José Rodriguez Cristóbal, ABS FLORIDA SUR
Jordi Gol i Gurina Foundation
Not Provided
Principal Investigator: Juan José Roodriguez-Cristóbal, Dr Catalan Institute of Health
Jordi Gol i Gurina Foundation
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP