Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients

NCT ID: NCT03488966

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity, Morbid Eating Disorder Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MB-EAT

Behavioral: group psychotherapy. Eight weekly sessions, each session is 2 hours in duration.

Group Type EXPERIMENTAL

Mindfulness Based Eating and Awareness Training

Intervention Type BEHAVIORAL

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.

Waitlist Control

Wait list control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Wnuk, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 14574339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20350028 (View on PubMed)

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: 10.1093/ntr/nts133. Epub 2012 Sep 17.

Reference Type RESULT
PMID: 22987786 (View on PubMed)

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.appet.2012.01.009. Epub 2012 Jan 10.

Reference Type RESULT
PMID: 22265753 (View on PubMed)

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. Obes Surg. 2012 Nov;22(11):1790-7. doi: 10.1007/s11695-012-0739-4.

Reference Type RESULT
PMID: 22930073 (View on PubMed)

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. 2010 Dec;18(6):260-4. doi: 10.1016/j.ctim.2010.09.008. Epub 2010 Nov 11.

Reference Type RESULT
PMID: 21130363 (View on PubMed)

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.

Reference Type RESULT
PMID: 23876574 (View on PubMed)

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

Reference Type RESULT
PMID: 20047019 (View on PubMed)

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.

Reference Type RESULT
PMID: 15256293 (View on PubMed)

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.

Reference Type RESULT
PMID: 1891520 (View on PubMed)

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.

Reference Type RESULT
PMID: 9429923 (View on PubMed)

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.

Reference Type RESULT
PMID: 22021603 (View on PubMed)

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):349-56. doi: 10.1007/s11695-009-9895-6. Epub 2009 Jun 25.

Reference Type RESULT
PMID: 19554382 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-5731

Identifier Type: -

Identifier Source: org_study_id

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