NCT06087185Completed
Obesity and Mindful Eating in Patients With Anxiety
Evaluation of the Effect of Mindful Eating in Patients With Anxiety and Obesity.
Source: ClinicalTrials.gov · Last updated 15 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 29 Aug 2023
- Start date
- 23 Mar 2023
- Primary completion date
- 16 Aug 2024
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Diseases
- Obesity
- NCT number
- NCT06087185
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 23 Mar 2023 to the primary completion date, 16 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- In individuals with obesity or control only, not having any psychiatric disorder;
- 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);
- Antisocial Personality Disorder;
- Eating Disorder.
Other
- 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;
- Have a clinical instability or immobility;
- Being in Pregnancy or Lactation;
Who the study is looking for
- 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)
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
Related publications
- Mindfulness-based eating in obesity and anxiety: a randomized controlled trial and feasibility assessment.Lancet Reg Health Am · 2026 · PMID 42482693
This page is information, not medical advice. Discuss any trial with your doctor.