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Group Motivational Intervention in Overweight/Obese Patients.

NCT ID: NCT01202292

Last Updated: 2010-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Lifestyle counseling

Group Type EXPERIMENTAL

Behavioral (e.g., Psychotherapy, Lifestyle Counseling)

Intervention Type BEHAVIORAL

Group motivational intervention consist in expert psychologist 32 monthly sessions (group intervention) on top of the diet plus exercise

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Control group receives the usual follow up: diet, exercise

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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ABS FLORIDA SUR

Principal Investigators

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Juan José Roodriguez-Cristóbal, Dr

Role: PRINCIPAL_INVESTIGATOR

Catalan Institute of Health

Locations

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ABS Florida Sud

L'Hospitalet Del Llobregat, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan Jose Rodriguez-Cristóbal, Dr

Role: CONTACT

[email protected]
0034934471080

Facility Contacts

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Juan José Rodriguez-Cristóbal, Dr

Role: primary

[email protected]
934471080

References

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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.

Reference Type BACKGROUND
PMID: 20298557 (View on PubMed)

Other Identifiers

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PI 070087

Identifier Type: -

Identifier Source: org_study_id