Obesity and Mindful Eating in Patients With Anxiety

NCT06087185 | Completed

• 2 other identifiers: 66476322.5.0000.53272022-0551
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Anxiety; Obesity; Eating Behavior; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Change in Inhibitory Control

  To evaluate the effectiveness of the Mindful Eating (ME) intervention in the performance in Go/No-go task compared to the control group with exposure to videos. This paradigm consists of the presentation of neutral images and food images on a computer screen (presented randomly, with a millisecond interval between them) and the participant must press or not press a key according to the researcher's instructions. The participant will be instructed to press the specific "Go" key when certain neutral images are viewed (office objects and bathroom objects). When food images and another class of neutral images (sports objects) are viewed, the participant will be instructed not to press any key and just wait (No Go). The "Go/No Go" paradigm, which has high reliability and replicability, makes it possible to evaluate inhibitory control, considering the commissioned number of errors in the No Go outcome.

  5 weeks

Secondary Outcomes (15)

• Change in Inflammatory Markers

  5 weeks

• Change in Emotional Regulation

  5 weeks

• Change in Self-Compassion

  5 weeks

• Change in Impulsivity

  5 weeks

• Change in Emotional Eating

  5 weeks

Study Arms (2)

Mindful Eating Group

EXPERIMENTAL

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.

Behavioral: Mindful Eating

Video Group

ACTIVE COMPARATOR

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.

Behavioral: Video Group

Interventions

Mindful Eating 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.

Also known as: Mindfulness, Eat for Life protocol

Mindful Eating Group

Video Group 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.

Video Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between 18 and 50 years old;
• Primary GAD diagnosed by the M.I.N.I.;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Health Science of Porto Alegre: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Links

• OMETA Instagram

MeSH Terms

Conditions

Anxiety Disorders; Obesity; Feeding Behavior; Inflammation; Self-Control

Interventions

Mindfulness; Eating

Condition Hierarchy (Ancestors)

Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Pathologic Processes; Social Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Gisele G Manfro, PhD

  Federal University of Health Science of Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: October 17, 2023
• Study Start: March 23, 2023
• Primary Completion: August 16, 2024
• Study Completion: November 30, 2024
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)