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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Unknown

Conditions: Overweight; Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01202292

PI 070087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,200 participants in 1 patient group

Lifestyle counseling

Experimental group

Treatment:

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