Obesity and Mindful Eating in Patients With Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-23

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Anxiety Obesity Eating Behavior Mindfulness Inflammation Self-Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Randomized Clinical Trial (RCT) comparing the effectiveness of the adapted Mindful Eating protocol to the control with exposure to videos promoting quality of life in adults with anxiety and obesity.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindful Eating Group

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.

Group Type EXPERIMENTAL

Mindful Eating

Intervention Type BEHAVIORAL

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.

Video Group

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.

Group Type ACTIVE_COMPARATOR

Video Group

Intervention Type BEHAVIORAL

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.

Interventions

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Mindful Eating

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.

Intervention Type BEHAVIORAL

Video Group

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindfulness Eat for Life protocol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No