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

Primary Purpose

Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight focused on measuring overweight, obesity, motivational intervention

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ABS Florida SudRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

Outcomes

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.

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.

Full Information

First Posted
May 31, 2010
Last Updated
September 30, 2010
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT01202292
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
overweight, obesity, motivational intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
Other Intervention Name(s)
Control group receives the usual follow up: diet, exercise
Intervention Description
Group motivational intervention consist in expert psychologist 32 monthly sessions (group intervention) on top of the diet plus exercise
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

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 (severe, uncorrected deafness, severe visual deficit, etc). Patients with serious psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Jose Rodriguez-Cristóbal, Dr
Phone
0034934471080
Email
21002jrc@comb.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan José Roodriguez-Cristóbal, Dr
Organizational Affiliation
Catalan Institute of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
ABS Florida Sud
City
L'Hospitalet del Llobregat
State/Province
Barcelona
ZIP/Postal Code
08095
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan José Rodriguez-Cristóbal, Dr
Phone
934471080
Email
21002jrc@comb.es
First Name & Middle Initial & Last Name & Degree
Juan José Rodriguez Cristóbal, Dr

12. IPD Sharing Statement

Citations:
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
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Group Motivational Intervention in Overweight/Obese Patients.

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