NCT07131332

Brief Summary

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:

  • 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

August 4, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

mindfulnessovereatingmetabolic and bariatric surgerymindful eatingadults

Outcome Measures

Primary Outcomes (1)

  • Binge Eating Scale

    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.

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

Secondary Outcomes (5)

  • 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.

Study Arms (1)

Mindful eating group

EXPERIMENTAL

Behavioral group intervention involving 8, 2-hour long sessions

Behavioral: Mindful eating group

Interventions

Behavioral group intervention involving 8, 2-hour long sessions

Mindful eating group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Inability to speak, read and write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Wnuk, S.M., Du, C.T., Van Exan, J. et al. Mindfulness-Based Eating and Awareness Training for Post-Bariatric Surgery Patients: a Feasibility Pilot Study. Mindfulness 9, 949-960 (2018).

    BACKGROUND
  • Chacko SA, Yeh GY, Davis RB, Wee CC. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial. Complement Ther Med. 2016 Oct;28:13-21. doi: 10.1016/j.ctim.2016.07.001. Epub 2016 Jul 12.

    PMID: 27670865BACKGROUND
  • Kristeller JL, Wolever RQ. Mindfulness-based eating awareness training for treating binge eating disorder: the conceptual foundation. Eat Disord. 2011 Jan-Feb;19(1):49-61. doi: 10.1080/10640266.2011.533605.

    PMID: 21181579BACKGROUND
  • Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, Simpson TL. Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2018 Feb;59:52-60. doi: 10.1016/j.cpr.2017.10.011. Epub 2017 Nov 8.

    PMID: 29126747BACKGROUND
  • Chesler BE. Emotional eating: a virtually untreated risk factor for outcome following bariatric surgery. ScientificWorldJournal. 2012;2012:365961. doi: 10.1100/2012/365961. Epub 2012 Apr 1.

    PMID: 22566765BACKGROUND
  • Rutledge T, Groesz LM, Savu M. Psychiatric factors and weight loss patterns following gastric bypass surgery in a veteran population. Obes Surg. 2011 Jan;21(1):29-35. doi: 10.1007/s11695-009-9923-6. Epub 2009 Jul 15.

    PMID: 19847571BACKGROUND
  • White MA, Kalarchian MA, Masheb RM, Marcus MD, Grilo CM. Loss of control over eating predicts outcomes in bariatric surgery patients: a prospective, 24-month follow-up study. J Clin Psychiatry. 2010 Feb;71(2):175-84. doi: 10.4088/JCP.08m04328blu. Epub 2009 Oct 20.

    PMID: 19852902BACKGROUND
  • Mitchell JE, Lancaster KL, Burgard MA, Howell LM, Krahn DD, Crosby RD, Wonderlich SA, Gosnell BA. Long-term follow-up of patients' status after gastric bypass. Obes Surg. 2001 Aug;11(4):464-8. doi: 10.1381/096089201321209341.

    PMID: 11501356BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorHyperphagia

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 20, 2025

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
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