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
  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: 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.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 31, 2010
Last Updated: September 30, 2010
Health Authority: Spain: Ethics Committee

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

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014