Clinical trial NCT06087185: Obesity and Mindful Eating in Patients With Anxiety
Official title: Evaluation of the Effect of Mindful Eating in Patients With Anxiety and Obesity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Obesity
Eating Behavior
Mindfulness
Inflammation
Self-Control
Keywords: Anxiety
Obesity
Eating Behavior
Mindfulness
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Health Science of Porto Alegre
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2023-10-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Inhibitory Control
timeFrame: 5 weeks
Secondary outcomes:
measure: Change in Inflammatory Markers
timeFrame: 5 weeks
measure: Change in Emotional Regulation
timeFrame: 5 weeks
measure: Change in Self-Compassion
timeFrame: 5 weeks
measure: Change in Impulsivity
timeFrame: 5 weeks
measure: Change in Emotional Eating
timeFrame: 5 weeks
measure: Change in Binge Eating
timeFrame: 5 weeks
measure: Change in Body Appreciation
timeFrame: 5 weeks
measure: Change in Parental Bonding
timeFrame: 5 weeks
measure: Change in Early Memories
timeFrame: 5 weeks
measure: Change in Early Life Experiences
timeFrame: 5 weeks
measure: Change in Experiences in Close Relationships
timeFrame: 5 weeks
measure: Change in Weight Bias Internalization
timeFrame: 5 weeks
measure: Change in BMI
timeFrame: 5 weeks
measure: Change in Body Fat - Bioimpedance index
timeFrame: 5 weeks
measure: Change in Insulin resistance
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Gisele G Manfro, PhD
role: STUDY_DIRECTOR
References: