Obesity and Mindful Eating in Patients With Anxiety (OMETA)

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Inflammation; Eating Behavior; Mindfulness; Obesity; Anxiety; Self-Control

Treatments: Behavioral: Video Group; Behavioral: Mindful Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT06087185

66476322.5.0000.5327

2022-0551

Details and patient eligibility

About

Background: Obesity is chronic disease with high prevalence rates, functional disability and difficult long-term management. Anxiety is one of the most common psychological disorders in obesity, and when associated with other factors such as emotional eating and emotional dysregulation, it impairs treatment and interferes with lifestyle changes. Finding an intervention that improves the eating behavior of these patients and facilitates adherence to obesity treatment, associated with less emotional distress, is of great clinical interest. Objective: The aim of this study is to evaluate the effectiveness of the Mindful Eating (ME) intervention on neurocognitive and behavioral outcomes in patients with obesity and anxiety compared to the control group with exposure to videos promoting quality of life. Methods: A five-weeks randomized clinical trial will be performed with 52 patients in adulthood. The Mindful Eating intervention group will receive an online protocol with one meeting per week. This is a protocol that has been adapted for five weeks and consists of a group intervention with 10-15 participants. Mindfulness, Mindful Eating and Self-Compassion training will be based on the Eat for Life protocol. The control group will receive five videos of psychoeducation, one topic per week. After, all participants will receive lifestyle advices, a first-line "treatment-as-usual" to obesity. There will be a face-to-face assessment with anthropometric, behavioral and biological measurements pre and post-intervention. The outcomes may help in understanding the mechanisms underlying the change in eating behavior, in order to direct new therapeutic strategies for the treatment of anxiety and obesity comorbidities.

Full description

This study is the second phase of a cross-sectional study.

Enrollment: 70 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be between 18 and 50 years old;
• Inclusion for Generalized Anxiety Disorder (GAD):

Primary GAD diagnosed by the M.I.N.I.;

✔Inclusion for Obesity: Obesity BMI grade I (between 30.0 and 34.9); Obesity BMI grade II (between 35.0 and 39.9)

Exclusion criteria

• In individuals with obesity or control only, not having any psychiatric disorder;
• In individuals with only GAD or control, do not have a BMI above 25.
• In individuals with GAD, not having a diagnosis of primary or severe depression;
• Being under psychopharmacological, psychotherapeutic or nutritional treatment;
• Bipolar Disorder, Psychotic Disorder, Substance Use Disorder (except Tobacco) in the last 6 months or Suicidal Ideation in the last 6 months (M.I.N.I);
• Have a clinical instability or immobility;
• Being in Pregnancy or Lactation;
• Antisocial Personality Disorder;
• Eating Disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Mindful Eating Group

Experimental group

Description:

Mindful Eating practices will be taught during a weekly meeting lasting 150 minutes and individuals will be encouraged to integrate the practices learned into their daily lives, for at least 15 minutes a day, being progressively integrated into the other practices that will be taught in subsequent weeks. There will be a WhatsApp group with reminders during the week and audio for guided practice.

Treatment:

Behavioral: Mindful Eating

Video Group

Active Comparator group

Description:

Composed of 5 videos sent weekly produced by trained professionals. The topics discussed will be relevant to the management of anxiety in general and lifestyle changes. Video 1: Psychoeducation of anxiety. Video 2: Healthy eating. Video 3: Sleep hygiene. Video 4: Physical activity. Video 5: Substance use. This protocol used as a control was effective as a Psychoeducation Group in improving anxiety symptoms in patients with generalized anxiety disorder.

Treatment:

Behavioral: Video Group