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Group Motivational Intervention in Overweight/Obese Patients (IMOAP)

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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status

Unknown

Conditions

Overweight
Obesity

Treatments

Behavioral: Motivational intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01006213
PI070087

Details and patient eligibility

About

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.

Enrollment

1,200 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,200 participants in 1 patient group

Lifestyle counseling vs motivational intervention
Experimental group
Treatment:
Behavioral: Motivational intervention

Trial contacts and locations

1

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Central trial contact

JUAN JOSE RODRIGUEZ-CRISTOBAL, DR

Data sourced from clinicaltrials.gov

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