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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202292
First Posted: September 15, 2010
Last Update Posted: October 1, 2010
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.
Information provided by:
Jordi Gol i Gurina Foundation
  Purpose
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 Intervention
Overweight Obesity Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)

Study Type: Interventional
Study Design: 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.

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 1200
Study Start Date: January 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01202292


Contacts
Contact: Juan Jose Rodriguez-Cristóbal, Dr 0034934471080 21002jrc@comb.es

Locations
Spain
ABS Florida Sud Recruiting
L'Hospitalet del Llobregat, Barcelona, Spain, 08095
Contact: Juan José Rodriguez-Cristóbal, Dr    934471080    21002jrc@comb.es   
Principal Investigator: Juan José Rodriguez Cristóbal, Dr         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
Principal Investigator: Juan José Roodriguez-Cristóbal, Dr Catalan Institute of Health
  More Information

Publications:
Responsible Party: Juan José Rodriguez Cristóbal, ABS FLORIDA SUR
ClinicalTrials.gov Identifier: NCT01202292     History of Changes
Other Study ID Numbers: PI 070087
First Submitted: May 31, 2010
First Posted: September 15, 2010
Last Update Posted: October 1, 2010
Last Verified: September 2010

Keywords provided by Jordi Gol i Gurina Foundation:
overweight
obesity
motivational intervention

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms