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Group Motivational Intervention in Overweight/Obese Patients

Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area (IMOAP)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01006213
Acronym
IMOAP
Enrollment
1200
Registered
2009-11-02
Start date
2008-01-31
Completion date
2010-12-31
Last updated
2009-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, Obesity

Keywords

Motivational Intervention

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: 1. 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. 2. 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.

Interventions

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)

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
If a group of motivational intervention, together with current clinical practice, is more efficient than the latter in the treatment of overweight and obesitytwo years

Secondary

MeasureTime frame
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)two years

Countries

Spain

Contacts

Primary ContactJUAN JOSE RODRIGUEZ-CRISTOBAL, DR
21002jrc@comb.es0034932611672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026