OvereatingNCT04531436
Testing a Brief Mindful Eating Program
A study testing Brief mindful eating intervention in people with Overeating and Overweight, run by McGill University at 1 site in Canada.
Trial summary
This project evaluated the effects of a brief manualized mindful eating intervention as a treatment for overeating with individuals with overweight and obesity. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Overeating, Overweight, Obesity
- What is being tested?
- Brief mindful eating intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 25 to 45 kg/m2 (overweight/obese)
- Willingness to commit to program and complete various assessment measures
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing a Brief Mindful Eating Program: Feasibility and Proof of Concept
This project evaluated the effects of a brief manualized mindful eating intervention as a treatment for overeating with individuals with overweight and obesity.
Read the 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.
- Conditions
- Overeating, Overweight, Obesity
- Being tested
- Brief mindful eating intervention
- Keywords
- Mindful eating, Overweight, Obesity, Intuitive eating, Overeating, Self-compassion
- Medical subject headings
- Hyperphagia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief mindful eating interventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Brief mindful eating intervention Receives: Other: Brief mindful eating intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, week 9, and 24-week follow-up
Secondary outcomes (1)
Change in body weight
Change in body weight (lbs)
Measured: Baseline, week 9, and 24-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Sep 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OvereatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot feasibility trial
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbel Knauper, McGill University
- Investigators
- Bärbel Knauper, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531436
- Sponsor's protocol ID
- 46-0617
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Brief Mindful Eating Program: Feasibility and Proof of Concept
- ClinicalTrials.gov ID
- NCT04531436
- Acronym / sponsor ID
- 46-0617
- Conditions
- Overeating, Overweight, Obesity
- Keywords
- Mindful eating, Overweight, Obesity, Intuitive eating, Overeating, Self-compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Brief mindful eating interventionBrief mindful eating intervention |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI of 25 to 45 kg/m2 (overweight/obese)
- Willingness to commit to program and complete various assessment measures
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief mindful eating interventionOver 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). | Other | Intervention |
Primary outcome
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
1 secondary outcome
Change in body weight
Time frame: Baseline, week 9, and 24-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
Related trials for Overeating
Active, not recruiting
Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods
Obesity, Overeating
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bärbel Knauper, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief mindful eating intervention in people with Overeating and Overweight, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overeating (time frame: Baseline, week 9, and 24-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020; AzTrials last refreshed its copy on 27 Oct 2026.