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Testing a Brief Mindful Eating Program

Primary Purpose

Overeating, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brief mindful eating intervention
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overeating focused on measuring Mindful eating, Overweight, Obesity, Intuitive eating, Overeating, Self-compassion

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI of 25 to 45 kg/m2 (overweight/obese)
  • Willingness to commit to program and complete various assessment measures

Exclusion Criteria:

  • Having been pregnant in the past six months or planning on becoming pregnant in the next year
  • Undergoing treatment for cancer
  • Using medications that affect body weight or appetite
  • Being diagnosed with bulimia nervosa, binge-eating disorder, major depressive disorder, or another severe psychiatric disease (including dementia)

Sites / Locations

  • McGill University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Brief mindful eating intervention

Outcomes

Primary Outcome Measures

Change in overeating
As measured by the Overeating Questionnaire. Scores can range from 0 to 40, with higher scores indicating a greater tendency to overeat

Secondary Outcome Measures

Change in body weight
Change in body weight (lbs)

Full Information

First Posted
August 11, 2020
Last Updated
August 26, 2020
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT04531436
Brief Title
Testing a Brief Mindful Eating Program
Official Title
Testing a Brief Mindful Eating Program: Feasibility and Proof of Concept
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project evaluated the effects of a brief manualized mindful eating intervention as a treatment for overeating with individuals with overweight and obesity.
Detailed Description
Overeating leads to overweight and obesity. Effective eating regulation largely depends on an individual's responsiveness to internal cues of physiological hunger and satiety; this phenomenon is known as interoceptive awareness and has been shown to be lower in individuals with overweight or obesity. Mindfulness training may improve interoceptive awareness and thus may facilitate more effective regulation of eating through increased sensitivity to cues of hunger and fullness. Mindful eating programs have been shown to increase interoceptive awareness of hunger and satiety cues and decrease weight in individuals with obesity. Although these programs are effective, they involve lengthy group sessions, require extensively trained staff, and are not widely available outside of clinical research. Thus, the reach and impact of these programs are limited. The present study developed and tested a brief mindful eating intervention inspired by Kristeller & Wolever's (2010) Mindfulness-Based Eating Awareness Training program to increase interoceptive awareness in individuals with overweight and obesity as a means to increase mindful and intuitive eating, reduce overeating and facilitate weight loss. The program consisted of 9 weekly 10-15 minute sessions structured around one simple evidence-based mindful eating exercise, and was delivered to adult (ages 18-67) employees from a Canadian university.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overeating, Overweight, Obesity
Keywords
Mindful eating, Overweight, Obesity, Intuitive eating, Overeating, Self-compassion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot feasibility trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Brief mindful eating intervention
Intervention Type
Other
Intervention Name(s)
Brief mindful eating intervention
Intervention Description
Over the 9-week intervention, participants will be introduced to various mindful eating and intuitive eating practices which are aimed at reducing overeating and facilitating weight loss. Each session will focus on one simple, evidence-based message, aimed at modifying a current weight-relevant eating behavior of the patient. The intervention will focus on two key elements: (1) the mindful awareness of body cues (intuitive eating) and (2) the mindful awareness of external cues (mindful eating).
Primary Outcome Measure Information:
Title
Change in overeating
Description
As measured by the Overeating Questionnaire. Scores can range from 0 to 40, with higher scores indicating a greater tendency to overeat
Time Frame
Baseline, week 9, and 24-week follow-up
Secondary Outcome Measure Information:
Title
Change in body weight
Description
Change in body weight (lbs)
Time Frame
Baseline, week 9, and 24-week follow-up
Other Pre-specified Outcome Measures:
Title
Change in mindful eating
Description
As measured by the Mindful Eating Questionnaire. Scores can range between 28 and 112, with higher scores indicating greater levels of mindful eating
Time Frame
Baseline, week 7, 24-week follow-up
Title
Self-compassion
Description
As measured by the Self-Compassion Scale Short Form. Scores range between 26 and 130, with higher scores indicating greater levels of self-compassion
Time Frame
Baseline
Title
Change in intuitive eating
Description
As measured by the Intuitive Eating Scale. Scores can range from 21 to 105, with higher scores indicating greater levels of intuitive eating
Time Frame
Baseline, week 7, 24-week follow-up
Title
Cognitive restraint
Description
As measured by the cognitive restraint subscale of the Three Factor Eating Questionnaire. Scores for this subscale range between 3 and 12, with higher scores indicating greater levels of cognitive restraint
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI of 25 to 45 kg/m2 (overweight/obese) Willingness to commit to program and complete various assessment measures Exclusion Criteria: Having been pregnant in the past six months or planning on becoming pregnant in the next year Undergoing treatment for cancer Using medications that affect body weight or appetite Being diagnosed with bulimia nervosa, binge-eating disorder, major depressive disorder, or another severe psychiatric disease (including dementia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bärbel Knauper, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A1G1
Country
Canada

12. IPD Sharing Statement

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Testing a Brief Mindful Eating Program

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