- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04531436
Testing a Brief Mindful Eating Program
Testing a Brief Mindful Eating Program: Feasibility and Proof of Concept
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3A1G1
- McGill University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Brief mindful eating intervention
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in overeating
Time Frame: Baseline, week 9, and 24-week follow-up
|
As measured by the Overeating Questionnaire.
Scores can range from 0 to 40, with higher scores indicating a greater tendency to overeat
|
Baseline, week 9, and 24-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body weight
Time Frame: Baseline, week 9, and 24-week follow-up
|
Change in body weight (lbs)
|
Baseline, week 9, and 24-week follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mindful eating
Time Frame: Baseline, week 7, 24-week follow-up
|
As measured by the Mindful Eating Questionnaire.
Scores can range between 28 and 112, with higher scores indicating greater levels of mindful eating
|
Baseline, week 7, 24-week follow-up
|
Self-compassion
Time Frame: Baseline
|
As measured by the Self-Compassion Scale Short Form.
Scores range between 26 and 130, with higher scores indicating greater levels of self-compassion
|
Baseline
|
Change in intuitive eating
Time Frame: Baseline, week 7, 24-week follow-up
|
As measured by the Intuitive Eating Scale.
Scores can range from 21 to 105, with higher scores indicating greater levels of intuitive eating
|
Baseline, week 7, 24-week follow-up
|
Cognitive restraint
Time Frame: Baseline
|
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
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 46-0617
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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