Efficacy of a Mindful Eating Program to Reduce Emotional Eating in Patients Suffering From Overweight or Obesity in Primary Care Settings: a Cluster Randomized Controlled Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- The Dutch Eating Behavior Questionnaire
研究概览
简要总结
Mindfulness-Based Interventions have been applied in different fields to improve physical and psychological health. However, little is known about its applicability and effectiveness in Spanish adults with overweight and obesity. The aim of the present study protocol is to evaluate the feasibility and efficacy of an adapted MBI programme to reduce emotional eating in adults with overweight and obesity in primary care (PC) settings.
详细描述
This study is a multi-centre, two-armed randomized controlled trial (RCT), with pre-treatment, post-treatment and 1-year follow-up measures, and a 1:1 allocation rate between groups. Patients from four mental health units in Zaragoza (Spain) will be randomly assigned to two different parallel conditions, with one psychological intervention group ('ME + TAU') and usual treatment ('TAU alone') managed by their general practitioner (GP), to test the superiority of 'ME + TAU' provision compared with 'TAU alone' provision. For ethical reasons, those patients allocated to 'TAU alone' will be offered the ME programme after finishing the trial at 1-year follow-up.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45-75 years
- •Have overweight or obesity condition based in BMI (Body Mass Index). Individuals with BMI of 25 or more.
- •Have two of these three risk: sedentary lifestyle, poor diet and binge episodes.
- •Ability to understand oral and written Spanish.
- •Willingness to participate in the study and signing informed consent.
排除标准
- •Any diagnosis of a disease that may affect the central nervous system (brain condition, traumatic brain injury, dementia, etc).
- •Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, etc.), except for anxiety disorder or personality disorders.
- •Presence of delusional ideas or hallucinations whether consistent or not with mood.
- •Suicide risk.
结局指标
主要结局
The Dutch Eating Behavior Questionnaire
时间窗: twelve-months follow-up in experimental and control groups
It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".
次要结局
- Sociodemographic data Gender, age, marital status, education, occupation, economical level(Baseline in experimental and control groups)
- Five Facet Mindfulness Questionnaire(twelve-months follow-up in experimental and control groups)
- Self-Compassion Scale(twelve-months follow-up in experimental and control groups)
- Mindful Eating Scale(twelve-months follow-up in experimental and control groups)
- Bulimic Investigatory Test(twelve-months follow-up in experimental and control groups)
- Eating Attitude test (EAT-26)(twelve-months follow-up in experimental and control groups)
- Weight(twelve-months follow-up in experimental and control groups)
- HDL(twelve-months follow-up in experimental and control groups)
- Glucose(twelve-months follow-up in experimental and control groups)
- Alanine aminotransferase(twelve-months follow-up in experimental and control groups)
- Patient Health Questionnaire(twelve-months follow-up in experimental and control groups)
- The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)(twelve-months follow-up in experimental and control groups)
- Abdominal perimeter(twelve-months follow-up in experimental and control groups)
- Height(twelve-months follow-up in experimental and control groups)
- Cholesterol total(twelve-months follow-up in experimental and control groups)
- LDL(twelve-months follow-up in experimental and control groups)
- Glycated haemoglobin(twelve-months follow-up in experimental and control groups)
- General Anxiety Disorder(twelve-months follow-up in experimental and control groups)
研究者
Javier Garcia Campayo
Principal Investigator
Hospital Miguel Servet