跳至主要内容
临床试验/NCT07131332
NCT07131332已完成不适用

Mindfulness Based Eating and Awareness Training for Post-bariatric Surgery Patients: A Mixed Methods Outcome Study

University Health Network, Toronto0 个研究点目标入组 45 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
主要终点
Binge Eating Scale

研究概览

简要总结

The goal of this clinical trial was to see if learning and practicing mindful eating in a group was helpful for people who had bariatric surgery. The main questions it aims to answer are:

  1. Does learning and practicing mindful eating help decrease overeating, improve mood, decrease anxiety, and lead to other similar changes?
  2. What do people who participated in a mindful eating group find helpful and hindering about it?

Participants were asked to:

  • take part in an 8-week mindful eating group
  • complete questionnaires before the group started and after it ended, about their eating habits, mood, anxiety and other similar issues
  • complete a questionnaire right after each session asking them what they found helpful and hindering about that session

详细描述

BACKGROUND: Bariatric surgery, specifically the roux-en-y gastric bypass and gastric sleeve, has been conducted at the University Health Network Surgery Program (UHN-BSP) since late 2009. Weight loss through bariatric surgery is associated with the improvement or resolution of medical comorbidities as well as improvements in patient-reported quality of life. Bariatric surgery is also more successful than other weight loss methods in maintaining weight loss. Therefore, weight regain is of primary concern in this population. Psychiatric factors associated with weight regain include binge eating, lack of control over food urges and a greater number of psychiatric disorders.

Mindfulness meditation techniques may address many of the factors related to disordered eating that contributes to weight regain, including distressing emotions and cognitive distortions. Mindfulness training involves purposeful and sustained attention to thoughts, emotions and bodily sensations. This encourages the recognition of and improved ability to tolerate painful emotions without engaging in problematic behavior like overeating. Mindfulness is a well-validated intervention for psychological and medical problems in other patient populations, including anxiety, depression, stress. Mindfulness-Based Eating Awareness Training (MB-EAT) is a group program developed by Kristeller and colleagues that integrates mindfulness meditation and eating meditation with didactics about healthy eating.

Mindfulness and mindful eating practice may help individuals better recognize and respond to feelings of hunger and fullness. Bariatric surgery patients tend to have a history of multiple weight-loss diet attempts. These diets usually emphasize rules for how much, when and what to eat that paradoxically lead to the loss of one's ability to recognize, accept or respond to internal cues of hunger, taste, satiety, and fullness. Studies that that investigated mindful eating interventions for bariatric surgery patients indicate that they improve eating behavior, emotion regulation, and depression. The investigators conducted one of these studies and found that depression and binge eating significantly decreased from pre to post intervention and emotion regulation significantly improved.

OBJECTIVES:

Primary Objective: To quantitatively investigate the effectiveness of MB-EAT in enhancing psychological functioning as an adjunct treatment to the usual standard of care in the 40 bariatric surgery patients who participated in MB-EAT groups.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Any patient enrolled in the University Health Network Bariatric Surgery Program
  • •Able to speak, read and write English

排除标准

  • •- Inability to speak, read and write English

研究组 & 干预措施

Mindful eating group

Experimental

Behavioral group intervention involving 8, 2-hour long sessions

干预措施: Mindful eating group (Behavioral)

结局指标

主要结局

Binge Eating Scale

时间窗: Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later)

Self-report questionnaire of eating behaviour typical of binge eating. It contains 16 items and responses for each item range from 1-4. The minimum score is 0 and the maximum score is 46. Higher scores indicate more binge eating.

Binge Eating Scale

时间窗: Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later)

Self-report questionnaire of eating behaviour typical of binge eating. It contains 16 items and responses for each item range from 1-4. The minimum score is 0 and the maximum score is 46. Higher scores indicate more binge eating.

次要结局

  • Patient Health Questionnaire 9(Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).)
  • Generalized Anxiety Disorder 7(Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).)
  • Five facets of mindfulness questionnaire(Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).)
  • Multidimensional Assessment of Interoceptive Awareness(Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).)
  • Helpful Aspects of Therapy Form(Immediately after the completion of each of 8 MB-EAT sessions from baseline (week 1) and weekly until week 8.)
  • Patient Health Questionnaire 9(Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).)
  • Generalized Anxiety Disorder 7(Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).)
  • Five facets of mindfulness questionnaire(Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).)
  • Multidimensional Assessment of Interoceptive Awareness(Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).)
  • Helpful Aspects of Therapy Form(Immediately after the completion of each of 8 MB-EAT sessions from baseline (week 1) and weekly until week 8.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Wnuk

Principal Investigator

University Health Network, Toronto

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