Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients

Obesity, Morbid Clinical Trial

— MB-EAT  

Official title:

Mindfulness Based Eating Awareness Training (MB-EAT) for Bariatric Surgery Patients: The Effects of Mindfulness on Psychosocial and Physical Functioning

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03488966
• Other study ID #: 16-5731
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of Mindfulness Based Eating Awareness Training (MB-EAT) for patients who have had bariatric surgery on their weight and mental and physical health compared to patients who do not do this group. All participants will complete questionnaires evaluating eating and mental health before and after the group and 6 and 12 months later. They will have blood pressure readings at these times and complete a questionnaire about their digestive health. Our hypothesis is that participants will maintain their weight loss after bariatric surgery and have improvements in the other outcomes.

Description:

MB-EAT may be helpful for reducing emotional eating, overeating and grazing, eating patterns that can lead to weight gain after bariatric surgery. Participants will receive MB-EAT 6 months or more following bariatric surgery. They will be randomly assigned to receive MB-EAT right away or 8 weeks later. Individuals in the group starting in 8 weeks will serve as a waitlist control group.The primary outcome measures will be changes in self-reported eating problems, depression, anxiety, and mindfulness. There will be a follow-up at 6 months and 12 months to establish stability of symptoms post-intervention. Participants will receive one introductory information session about the MB-EAT program, as well as 8 MB-EAT scheduled consecutively over eight weeks. Each session is approximately two hours in length. During MB-EAT, participants will practice mindfulness to help improve their decision making abilities about when and how much to eat. Through MB-EAT, participants will learn to address mindless or out-of-control eating, which can lead to weight gain. Homework will include daily meditations and mindful eating exercises.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Post-bariatric surgery patients recruited from the Toronto Western Hospital-Bariatric Surgery Program (TWH-BSP) who are six months or more post-surgery, are experiencing self-reported difficulties adhering to post-surgery eating guidelines, and can commit to attending the group.

2. Fluent in English.

3. Have the capacity to provide informed consent.

Exclusion Criteria:

1. Active suicidal ideation.

2. Active serious mental illness (i.e., psychotic disorder, bipolar disorder).

3. Active severe depression (i.e., current major depressive disorder diagnosis and PHQ-9 score > 20 [severe depression]).

4. Active severe anxiety (i.e., current anxiety disorder diagnosis and GAD-7 score > 15 [severe anxiety]).

5. Active symptoms of post-traumatic stress disorder (i.e., current diagnosis of post-traumatic stress disorder).

Related Conditions & MeSH terms

• Eating Disorder Symptom
• Feeding and Eating Disorders
• Obesity, Morbid

Intervention

Behavioral:
• Mindfulness Based Eating and Awareness Training
Eight sessions of Mindfulness Based Eating and Awareness Training (MB-EAT) will be delivered once per week over the course of 8 weeks, following an introductory session. The treatment uses general mindfulness meditation and eating meditation to help participants bring greater awareness and understanding to their relationship with food. Homework consists of weekly mindfulness exercises.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Adams CE, Benitez L, Kinsaul J, Apperson McVay M, Barbry A, Thibodeaux A, Copeland AL. Effects of brief mindfulness instructions on reactions to body image stimuli among female smokers: an experimental study. Nicotine Tob Res. 2013 Feb;15(2):376-84. doi: — View Citation

Alberts HJ, Thewissen R, Raes L. Dealing with problematic eating behaviour. The effects of a mindfulness-based intervention on eating behaviour, food cravings, dichotomous thinking and body image concern. Appetite. 2012 Jun;58(3):847-51. doi: 10.1016/j.ap — View Citation

Beck NN, Johannsen M, Stoving RK, Mehlsen M, Zachariae R. Do postoperative psychotherapeutic interventions and support groups influence weight loss following bariatric surgery? A systematic review and meta-analysis of randomized and nonrandomized trials. — View Citation

Dalen J, Smith BW, Shelley BM, Sloan AL, Leahigh L, Begay D. Pilot study: Mindful Eating and Living (MEAL): weight, eating behavior, and psychological outcomes associated with a mindfulness-based intervention for people with obesity. Complement Ther Med. — View Citation

Godsey J. The role of mindfulness based interventions in the treatment of obesity and eating disorders: an integrative review. Complement Ther Med. 2013 Aug;21(4):430-9. doi: 10.1016/j.ctim.2013.06.003. Epub 2013 Jul 9. — View Citation

Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. doi: 10.1177/1533210108329862. — View Citation

Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7. — View Citation

Heatherton TF, Baumeister RF. Binge eating as escape from self-awareness. Psychol Bull. 1991 Jul;110(1):86-108. doi: 10.1037/0033-2909.110.1.86. — View Citation

Herpertz S, Kielmann R, Wolf AM, Langkafel M, Senf W, Hebebrand J. Does obesity surgery improve psychosocial functioning? A systematic review. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1300-14. doi: 10.1038/sj.ijo.0802410. — View Citation

Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555. — View Citation

Kalarchian MA, Wilson GT, Brolin RE, Bradley L. Binge eating in bariatric surgery patients. Int J Eat Disord. 1998 Jan;23(1):89-92. doi: 10.1002/(sici)1098-108x(199801)23:13.0.co;2-i. — View Citation

Kristeller JL, Hallett CB. An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. J Health Psychol. 1999 May;4(3):357-63. doi: 10.1177/135910539900400305. — View Citation

Odom J, Zalesin KC, Washington TL, Miller WW, Hakmeh B, Zaremba DL, Altattan M, Balasubramaniam M, Gibbs DS, Krause KR, Chengelis DL, Franklin BA, McCullough PA. Behavioral predictors of weight regain after bariatric surgery. Obes Surg. 2010 Mar;20(3):349 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (BMI)	BMI as calculated by weight (kg) / height (cm)^2	Change from baseline to 8 weeks, 6 months, and 12 months
Primary	Change in weight	Weight in kilograms will be obtained by weighing participants	Change from baseline to 8 weeks, 6 months, and 12 months
Primary	Height	Height in centimetres will be obtained by measuring participants	Baseline
Secondary	Patient Health Questionnaire (PHQ-9)	A 9-item self-report measure of depression severity that yields a total score. Items are scored from 0-3. Higher values mean more depression. The total score is obtained by summing the items.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	Generalized Anxiety Disorder Questionnaire (GAD-7)	A 7-item self-report measure of anxiety severity that yields a total score. Items are scored from 0-3. Higher values mean more anxiety. The total score is obtained by summing the items.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	The Three Factor Eating Questionnaire -R18 (TFEQ-R18)	An 18 item self-report measure of eating behavior that yields a total score. Items are scored from 1-4. Higher values mean more anxiety. The total score is obtained by summing the items.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	Five Facets of Mindfulness Questionnaire (FFMQ)	A 39-item self-report measuring mindfulness that yields a total score. Items are scored from 1-5. Higher values mean more mindfulness except in the case of the following reverse-scored items: 3, 5, 8, 10, 12, 13, 14, 16, 17, 18, 22, 23, 25, 28, 34, 38, 30, 35, 39. After reverse scoring these items a total score is obtained by summing the items. Average score can be computed by dividing the total score by 39.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	Self-Compassion Scale (SCS)	A 26-item self-report measure of self-compassion that yields a total score. Items are scored from 1-5. Higher values mean more self-compassion except in the case of the following reverse-scored items: 1, 2, 4, 6, 8, 11, 13, 16, 18, 20, 21, 24, 25. After reverse scoring these items a total score is obtained by summing the items. Average score can be computed by dividing the total score by 26.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	Difficulties in Emotion Regulation Scale (DERS)	A 36-item self-report questionnaire of emotional difficulties that yields a total score. Items are scored from 1-5. Higher values mean more difficulties in emotion regulation, except in the case of the following reverse-scored items: 1, 2, 6, 7, 8, 10, 17, 20, 22, 24, 34. After reverse scoring these items a total score is obtained by summing the items and an average score is obtained by dividing the sum by 36.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	Body Satisfaction Questionnaire (BSQ)	A 34-item self-report measure of satisfaction with one's overall body that yields a total score. Items are scored from 0-5. Higher values mean more dissatisfaction with one's body. A total score is obtained by summing the items.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	Body Parts Satisfaction Scale (BPSS)	An 11-item self-report measure of satisfaction with specific body parts that yields a total score. Items are scored from 0-5. Higher values mean more dissatisfaction. A total score is obtained by summing the items.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	The Dichotomous Thinking Scale (DTS)	An 11-item self-report scale that measures the cognitive distortions and yields a total score. Items are scored from 1-4 with higher scores indication more cognitive distortions. A total score is obtained by summing the items.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	The Obesity Cognitions Scale	A 15 item scale that measures cognitive distortions surrounding food, weight, and shape that yields a total score. Items are scored from 0-5 with higher scores indication more cognitive distortions. A total score is obtained by summing the items.	Change from baseline to 8 weeks, 6 months, and 12 months
Secondary	Gastrointestinal Symptom Rating Scale (GSRS)	A 15 item self-report scale of gastrointestinal symptoms that yields a total score. Items are scored from 0 to 3 with higher scores indicated more frequent gastrointestinal discomfort. A total score is obtained by summing the items.	Change from baseline to 8 weeks, 6 months, and 12 months