Group Motivational Intervention in Overweight/Obese Patients (IMOAP)
Primary Purpose
Overweight, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Motivational intervention
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Motivational Intervention
Eligibility Criteria
Inclusion Criteria:
- Overweight (BMI>25) and obese (BMI>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
- Aged between 30 and 70 years
- Agreement to participate in the study
Exclusion Criteria:
- Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
- Patients with secondary obesity (hypothyroidism, Cushing's disease, etc).
- Patients with severe sensorial disorders capable of interfering with the motivational intervention
- Patients with serious psychiatric disorders
Sites / Locations
- Abs Florida SurRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle counseling vs motivational intervention
Arm Description
Outcomes
Primary Outcome Measures
If a group of motivational intervention, together with current clinical practice, is more efficient than the latter in the treatment of overweight and obesity
Secondary Outcome Measures
Observe whether this intervention is more effective for reducing cardiovascular risk factors (lipid profile, apo B-100, apo A-1, fibrinogen, reactive protein C, hypertension, diabetes mellitus)
Full Information
NCT ID
NCT01006213
First Posted
October 30, 2009
Last Updated
October 30, 2009
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT01006213
Brief Title
Group Motivational Intervention in Overweight/Obese Patients
Acronym
IMOAP
Official Title
Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area (IMOAP)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2008 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Overall mortality, such as that caused by cardiovascular disease, increases as weight increases. In the Framingham Study, it was shown that obesity is a cardiovascular risk factor independent of other risk factors such as type 2 diabetes mellitus, dyslipidemia and smoking.
Objectives:
To determine whether a group motivational intervention is more effective than the standard intervention for treatment of overweight and obesity and most importantly to maintain the attained weight loss on a permanent basis.
To assess whether this intervention is more effective than reducing cardiovascular risk factors (lipid profile, apo B-100, apo A-1, fibrinogen, C-reactive protein, hypertension, diabetes mellitus) associated with overweight and obesity, and the overall cardiovascular risk in these patients.
Design: Randomized, multicenter, interventional clinical trial in patients with overweight and obesity. Randomized assignment of the intervention by Basic Health Areas (BHAs). Two groups will be established in geographically separate areas, one of which will receive the group motivational intervention (intervention group) and the other will receive standard follow-up (control group). BHAs located in the same building will be assigned the same group (control or intervention) to avoid potential contamination. hypertensive treatment or with a diagnosis of hypertension in their clinical history.
Study Scope: Primary care. The study will be conducted in 24 BHAs of Hospitalet de Llobregat and Barcelona during 26months follow-up period. Haematic analyses will be in the carried out at the reference laboratory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Motivational Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling vs motivational intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Motivational intervention
Intervention Description
Two groups will be established in geographically separate areas, one of which will receive the group motivational intervention (intervention group) and the other will receive standard follow-up (control group)
Primary Outcome Measure Information:
Title
If a group of motivational intervention, together with current clinical practice, is more efficient than the latter in the treatment of overweight and obesity
Time Frame
two years
Secondary Outcome Measure Information:
Title
Observe whether this intervention is more effective for reducing cardiovascular risk factors (lipid profile, apo B-100, apo A-1, fibrinogen, reactive protein C, hypertension, diabetes mellitus)
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Overweight (BMI>25) and obese (BMI>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
Aged between 30 and 70 years
Agreement to participate in the study
Exclusion Criteria:
Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
Patients with secondary obesity (hypothyroidism, Cushing's disease, etc).
Patients with severe sensorial disorders capable of interfering with the motivational intervention
Patients with serious psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JUAN JOSE RODRIGUEZ-CRISTOBAL, DR
Phone
0034932611672
Email
21002jrc@comb.es
Facility Information:
Facility Name
Abs Florida Sur
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08905
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUAN JOSE RODRIGUEZ-CRISTOBAL, DR
Phone
0034932611672
Email
21002jrc@comb.es
First Name & Middle Initial & Last Name & Degree
JUAN JOSE RODRIGUEZ-CRISTOBAL, DR
12. IPD Sharing Statement
Citations:
PubMed Identifier
28633627
Citation
Rodriguez-Cristobal JJ, Alonso-Villaverde C, Panisello JM, Trave-Mercade P, Rodriguez-Cortes F, Marsal JR, Pena E. Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial. BMC Fam Pract. 2017 Jun 20;18(1):74. doi: 10.1186/s12875-017-0644-y.
Results Reference
derived
PubMed Identifier
22381072
Citation
Rodriguez Cristobal JJ, Alonso-Villaverde Grote C, Trave Mercade P, Perez Santos JM, Pena Sendra E, Munoz Lloret A, Fernandez Perez C, Bleda Fernandez D; EFAP group. Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease. BMC Res Notes. 2012 Mar 1;5:126. doi: 10.1186/1756-0500-5-126.
Results Reference
derived
PubMed Identifier
20298557
Citation
Rodriguez Cristobal JJ, Panisello Royo JM, Alonso-Villaverde Grote C, Perez Santos JM, Munoz Lloret A, Rodriguez Cortes F, Trave Mercade P, Benavides Marquez F, Marti de la Morena P, Gonzalez Burgillos MJ, Delclos Baulies M, Bleda Fernandez 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.
Results Reference
derived
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Group Motivational Intervention in Overweight/Obese Patients
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