Efficacy of a Mindful-eating Program to Reduce Emotional Eating

University Hospital Miguel Servet

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Mindful Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT03927534

05/2019

Details and patient eligibility

About

Mindfulness-Based Interventions have been applied in different fields to improve physical and psychological health. However, little is known about its applicability and effectiveness in Spanish adults with overweight and obesity. The aim of the present study protocol is to evaluate the feasibility and efficacy of an adapted MBI programme to reduce emotional eating in adults with overweight and obesity in primary care (PC) settings.

Full description

This study is a multi-centre, two-armed randomized controlled trial (RCT), with pre-treatment, post-treatment and 1-year follow-up measures, and a 1:1 allocation rate between groups. Patients from four mental health units in Zaragoza (Spain) will be randomly assigned to two different parallel conditions, with one psychological intervention group ('ME + TAU') and usual treatment ('TAU alone') managed by their general practitioner (GP), to test the superiority of 'ME + TAU' provision compared with 'TAU alone' provision. For ethical reasons, those patients allocated to 'TAU alone' will be offered the ME programme after finishing the trial at 1-year follow-up.

Enrollment: 76 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 45-75 years
• Have overweight or obesity condition based in BMI (Body Mass Index). Individuals with BMI of 25 or more.
• Have two of these three risk: sedentary lifestyle, poor diet and binge episodes.
• Ability to understand oral and written Spanish.
• Willingness to participate in the study and signing informed consent.

Exclusion criteria

• Any diagnosis of a disease that may affect the central nervous system (brain condition, traumatic brain injury, dementia, etc).
• Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, etc.), except for anxiety disorder or personality disorders.
• Presence of delusional ideas or hallucinations whether consistent or not with mood.
• Suicide risk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Experimental

Experimental group

Description:

Mindful Eating program is apply face to face 7 sessions of 120 minutes/session. ME is apply in groups of 10-12 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.

Treatment:

Behavioral: Mindful Eating

Control

No Intervention group

Description:

Treatment As Usual (TAU) in Primary Care (PC) is any kind of treatment administered by the GP to the patient with overweight and obesity. According to nutritional status, overweight or obesity, as well as the presence of co-morbidity, different actions can comprise the treatment offered at a PC level. For individuals presenting with overweight (BMI 25-29.9 kg/m2) but with no co-morbidities, PC teams organise care plans to enable them to achieve a normal BMI range (BMI 18.5-24.9 kg/m2). In case of suicide risk, severe social dysfunction or worsening of symptoms, it is recommended that patients are referred to mental health facilities.