Evaluation of the Effect of Mindful Eating in Patients With Anxiety and Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Inhibitory Control
研究概览
简要总结
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.
详细描述
This study is the second phase of a cross-sectional study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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.
研究组 & 干预措施
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.
干预措施: Mindful Eating (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.
干预措施: Video Group (Behavioral)
结局指标
主要结局
Change in Inhibitory Control
时间窗: 5 weeks
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.
次要结局
- Change in Emotional Regulation(5 weeks)
- Change in Early Memories(5 weeks)
- Change in Emotional Eating(5 weeks)
- Change in Binge Eating(5 weeks)
- Change in Parental Bonding(5 weeks)
- Change in Inflammatory Markers(5 weeks)
- Change in Impulsivity(5 weeks)
- Change in Weight Bias Internalization(5 weeks)
- Change in Self-Compassion(5 weeks)
- Change in Body Appreciation(5 weeks)
- Change in BMI(5 weeks)
- Change in Insulin resistance(5 weeks)
- Change in Early Life Experiences(5 weeks)
- Change in Experiences in Close Relationships(5 weeks)
- Change in Body Fat - Bioimpedance index(5 weeks)