Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients

NCT03488966 | Active Not Recruiting

• 1 other identifier: 16-5731
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Morbid; Eating Disorder Symptom

Keywords

Mindfulness; Bariatric Surgery; Obesity; Group psychotherapy

Outcome Measures

Primary Outcomes (3)

• 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

• Change in weight

  Weight in kilograms will be obtained by weighing participants

  Change from baseline to 8 weeks, 6 months, and 12 months

• Height

  Height in centimetres will be obtained by measuring participants

  Baseline

Secondary Outcomes (11)

• Patient Health Questionnaire (PHQ-9)

  Change from baseline to 8 weeks, 6 months, and 12 months

• Generalized Anxiety Disorder Questionnaire (GAD-7)

  Change from baseline to 8 weeks, 6 months, and 12 months

• The Three Factor Eating Questionnaire -R18 (TFEQ-R18)

  Change from baseline to 8 weeks, 6 months, and 12 months

• Five Facets of Mindfulness Questionnaire (FFMQ)

  Change from baseline to 8 weeks, 6 months, and 12 months

• Self-Compassion Scale (SCS)

  Change from baseline to 8 weeks, 6 months, and 12 months

Study Arms (2)

MB-EAT

EXPERIMENTAL

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

Behavioral: Mindfulness Based Eating and Awareness Training

Waitlist Control

NO INTERVENTION

Wait list control.

Interventions

Mindfulness Based Eating and Awareness Training 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.

MB-EAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Fluent in English.
• Have the capacity to provide informed consent.

You may not qualify if:

• Active suicidal ideation.
• Active serious mental illness (i.e., psychotic disorder, bipolar disorder).
• Active severe depression (i.e., current major depressive disorder diagnosis and PHQ-9 score \> 20 \[severe depression\]).
• Active severe anxiety (i.e., current anxiety disorder diagnosis and GAD-7 score \> 15 \[severe anxiety\]).
• Active symptoms of post-traumatic stress disorder (i.e., current diagnosis of post-traumatic stress disorder).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (13)

• 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.

  PMID: 14574339 BACKGROUND

• 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.

  PMID: 20350028 BACKGROUND

• 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.

  PMID: 22987786 RESULT

• 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.

  PMID: 22265753 RESULT

• 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.

  PMID: 22930073 RESULT

• 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.

  PMID: 21130363 RESULT

• 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.

  PMID: 23876574 RESULT

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

  PMID: 20047019 RESULT

• 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.

  PMID: 15256293 RESULT

• 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.

  PMID: 1891520 RESULT

• 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.

  PMID: 9429923 RESULT

• 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.

  PMID: 22021603 RESULT

• 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.

  PMID: 19554382 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Wnuk, Ph.D

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: April 5, 2018
• Study Start: March 20, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)