Group Motivational Intervention in Overweight/Obese Patients. (IMOAP)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 31, 2010 | ||||
| Last Updated Date | September 30, 2010 | ||||
| Start Date ICMJE | January 2008 | ||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01202292 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Group Motivational Intervention in Overweight/Obese Patients. | ||||
| Official Title ICMJE | Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area. | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: Lifestyle counseling
Intervention: Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1200 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01202292 | ||||
| Other Study ID Numbers ICMJE | PI 070087 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Juan José Rodriguez Cristóbal, ABS FLORIDA SUR | ||||
| Study Sponsor ICMJE | Jordi Gol i Gurina Foundation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Jordi Gol i Gurina Foundation | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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