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Emotional EatingNCT05347914

Mindfulness App for Reducing Food Cravings

A study testing Mindfulness in people with Emotional Eating, run by McGill University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

More than half of Canadian are overweight or obese and over fifty percent of individuals who are obese are emotional eaters. Emotional eating is defined as the tendency to eat in response to negative emotions and can be understood as reward-based eating behavior that is reinforced by modern obesogenic environments. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Emotional Eating
What is being tested?
Mindfulness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesCanada
Study dates
1 Jun 2022to 28 Aug 2023
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults (age > 18 years) who meet criteria for emotional eating
  • Demonstrate a lack of control over eating
  • High levels of preoccupation with food

Who cannot join

  • Having been pregnant in the past six months or planning on becoming pregnant in the next year
  • currently undergoing treatment for cancer
  • using medication that affects body weight or appetite
  • being diagnosed with Bulimia Nervosa, Binge Eating Disorder, currently active Major Depression, or other psychiatric illnesses that may affect appetite.
  • Participants must also be proficient in English
  • Own a smartphone

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • McGill University

    Montreal, Please Select..., H3A 1G1

  • McGill University

    Montreal, Quebec, H3A 1G1

Other trials in Canada

About this study

Official title: Mobile Mindfulness Intervention to Reduce Non-Homeostatic Food Cravings in Emotional Eaters: Research Pilot

More than half of Canadian are overweight or obese and over fifty percent of individuals who are obese are emotional eaters. Emotional eating is defined as the tendency to eat in response to negative emotions and can be understood as reward-based eating behavior that is reinforced by modern obesogenic environments. Over time, food-related cues can interfere with reward-based learning processes such that an individual develops a conditioned response to eat for reasons that are not associated with physiological hunger. Mindfulness has the potential to act on the reward-base habit loop of emotional eating. One potential target is cravings or the urges to eat. This can be targeted using the mindfulness exercise called "RAIN" which calls for individuals to (1) Recognize and name their craving, to (2) Acknowledge its presence and to give it space to "be"; (3) then Investigate and bring an attitude of curiosity to their experience - Where did these feelings comes from? Have I felt this way before? then (4) Not-identify with your experience- that is, remind yourself that although your craving or urge to eat is very powerful, it only makes up a small part of who you are. The aim of the study is to therefore test a pilot intervention that implements a targeted mindfulness-based exercise (RAIN), using a mobile app, to attenuate the relationship between feeling a negative internal state (affect) and eating.

Being tested
Mindfulness
Medical subject headings
Emotional Eating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MindfulnessBehavioural

    Participants will be taught a mindfulness exercise and will be instructed to use this exercise (following a mobile app) whenever they experience a food craving to eat for non-homeostatic reasons.

Study groups in NCT05347914
Study groupRoleWhat they receive
MindfulnessExperimentalNot described
Receives: Behavioral: Mindfulness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in food-related cravings

    Food Craving Questionnaire Measures the frequency and intensity of food cravings in general. The 15-item scale assesses six dimensions of craving experiences: lack of control overeating, thoughts or preoccupation with food, intentions and plans to consume food, emotions before and during food cravings, as cues that may trigger food cravings. Items are rated on a scale of 1 (never) to 6 (always). Sample items include: "I feel like I have food on my mind all the time", "I crave foods when I feel bored, angry or sad" and "If I am craving something, thoughts of eating consume me". This measure has shown high internal consistency (Cronbach alphas between .80 and .91)

    Measured: Baseline, week 6

  2. Change in emotional eating

    Dutch Eating Behaviour Questionnaire The DEBQ is a 33-item self-report measure that assesses three dimensions of eating behaviours: emotion eating, restrained eating, and external eating. Individual are asked to indicate the extent to which they agree with each statement from 1 (seldom) to 5 (very often). Sample items include "Do you have a desire to eat when you are anxious, worried or tense?" and "If you see other eating, do you also have a desire to eat?". This measure has shown high internal consistency (Cronbach's alpha = .95)

    Measured: Baseline, week 6

Secondary outcomes (5)

  1. Change in feelings of control around eating

    Brief Loss of Control Over-Eating Scale:

    The Brief Loss of Control Over-Eating Scale is a 7-item measure that assesses one's self-reported tendency to lose control over their eating behaviors. Items on the scale are rated from 1 (never) to 5 (always). Sample items include: "I felt like my cravings to eat overpowered me" and "I found myself eating despite negative consequences". The LOCES-B has shown high internal consistency (Cronbach alpha = .92)

    Measured: Baseline, week 6

  2. Change in overidentification with food cravings

    Cognitive Fusion Questionnaire- Food Cravings The Cognitive Fusion Questionnaire - Food Cravings is a (7-item) scale that assesses cognitive fusion with undesirable thoughts regards food craving and urges to eat. Sample items include: "It's very hard for me to let go of my food urges or cravings even when I know that letting go would be very helpful" and "I struggle to control my food urges or cravings." This measure has shown high internal consistency (Cronbach's alpha = .92).

    Measured: Baseline, week 6

  3. Change in reactivity towards eating related experiences

    UPPS-P Measure, Negative Urgency Scale:

    The UPPS-P Negative Urgency Scale is a 12-item measure that assess one's tendency to act rashly in response to negative mood states. Items on the scale are rated from 1 (I agree strongly) to 4 (I disagree strongly). Higher scores represent greater levels of impulsivity. Sample items include: "I have trouble controlling my impulses"). The UPPS-P Negative Urgency Scale has shown high internal consistency (Cronbach alpha = .88)

    Measured: Baseline, week 6

  4. Change in judgment towards eating related experiences

    Four Facet Mindful Eating Scale (FFaMES) The Four Facet Mindful Eating Scale is a 29-item self-report measure that assesses four dimensions of mindful eating: non-reactance, non-judgment, external awareness, and internal awareness. Individuals are asked to indicate the extent to which they agree with each statement from 1 (never) to 5 (very often). Sample items include: "I get carried away by my thoughts when I eat" and "I notice how the smell of food makes me want to eat." This measure has shown high internal consistency (non-reactance: Cronbach's alpha = .92, non-judgment: Cronbach's alpha = .91, external awareness: Cronbach's alpha = .82, internal awareness: Cronbach's alpha = .92).

    Measured: Baseline, week 6

  5. Change in capacity to tolerate distress

    Distress Tolerance Scale (DTS) The Distress Tolerance Scale is a 14-item scale that assesses an individual's ability to cope with various emotional states (e.g., happiness, anger, loneliness) that are in anticipating as well as in the present. Each item is rated on a scale of 1 (never) to 5 (all the time). Sample items include: "Felling distressed or upset is unbearable to me", "When I feel distressed or upset, all I can think about is how bad I feel" and "I can't handle feeling distressed or upset". The scale has shown high internal reliability (Cronbach's alpha = .91).

    Measured: Baseline, week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2022
  2. Study start1 Jun 2022
  3. Primary completion28 Aug 2023
  4. Study completion28 Aug 2023

Resources

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
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05347914
Sponsor's protocol ID
McGillU mindfulness app
Status last verified
Oct 2023
First submitted
16 Apr 2022
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anis AH, Zhang W, Bansback N, Guh DP, Amarsi Z, Birmingham CL. Obesity and overweight in Canada: an updated cost-of-illness study. Obes Rev. 2010 Jan;11(1):31-40. doi: 10.1111/j.1467-789X.2009.00579.x. Epub 2009 Apr 21.

    PubMed 19413707

  • Bongers P, de Graaff A, Jansen A. 'Emotional' does not even start to cover it: Generalization of overeating in emotional eaters. Appetite. 2016 Jan 1;96:611-616. doi: 10.1016/j.appet.2015.11.004. Epub 2015 Nov 10.

    PubMed 26559754

  • Born JM, Lemmens SG, Rutters F, Nieuwenhuizen AG, Formisano E, Goebel R, Westerterp-Plantenga MS. Acute stress and food-related reward activation in the brain during food choice during eating in the absence of hunger. Int J Obes (Lond). 2010 Jan;34(1):172-81. doi: 10.1038/ijo.2009.221. Epub 2009 Oct 20.

    PubMed 19844211

  • Brewer JA, Ruf A, Beccia AL, Essien GI, Finn LM, van Lutterveld R, Mason AE. Can Mindfulness Address Maladaptive Eating Behaviors? Why Traditional Diet Plans Fail and How New Mechanistic Insights May Lead to Novel Interventions. Front Psychol. 2018 Sep 10;9:1418. doi: 10.3389/fpsyg.2018.01418. eCollection 2018.

    PubMed 30250438

  • Cappelleri JC, Bushmakin AG, Gerber RA, Leidy NK, Sexton CC, Karlsson J, Lowe MR. Evaluating the Power of Food Scale in obese subjects and a general sample of individuals: development and measurement properties. Int J Obes (Lond). 2009 Aug;33(8):913-22. doi: 10.1038/ijo.2009.107. Epub 2009 Jun 9.

    PubMed 19506564

  • Carriere K, Shireen SH, Siemers N, Preissner CE, Starr J, Falk C, Knauper B. Development and Validation of the Four Facet Mindful Eating Scale (FFaMES). Appetite. 2022 Jan 1;168:105689. doi: 10.1016/j.appet.2021.105689. Epub 2021 Sep 10.

    PubMed 34517074

  • Dayan P, Niv Y. Reinforcement learning: the good, the bad and the ugly. Curr Opin Neurobiol. 2008 Apr;18(2):185-96. doi: 10.1016/j.conb.2008.08.003. Epub 2008 Aug 22.

    PubMed 18708140

  • Duarte C, Pinto-Gouveia J, Ferreira C, Silva B. Caught in the struggle with food craving: Development and validation of a new cognitive fusion measure. Appetite. 2016 Jun 1;101:146-55. doi: 10.1016/j.appet.2016.03.004. Epub 2016 Mar 2.

    PubMed 26946280

  • Elran Barak R, Shuval K, Li Q, Oetjen R, Drope J, Yaroch AL, Fennis BM, Harding M. Emotional Eating in Adults: The Role of Sociodemographics, Lifestyle Behaviors, and Self-Regulation-Findings from a U.S. National Study. Int J Environ Res Public Health. 2021 Feb 11;18(4):1744. doi: 10.3390/ijerph18041744.

    PubMed 33670147

  • Epel ES, Tomiyama AJ, Mason AE, Laraia BA, Hartman W, Ready K, Acree M, Adam TC, St Jeor S, Kessler D. The reward-based eating drive scale: a self-report index of reward-based eating. PLoS One. 2014 Jun 30;9(6):e101350. doi: 10.1371/journal.pone.0101350. eCollection 2014.

    PubMed 24979216

  • Epstein LH, Leddy JJ, Temple JL, Faith MS. Food reinforcement and eating: a multilevel analysis. Psychol Bull. 2007 Sep;133(5):884-906. doi: 10.1037/0033-2909.133.5.884.

    PubMed 17723034

  • Konttinen H, Mannisto S, Sarlio-Lahteenkorva S, Silventoinen K, Haukkala A. Emotional eating, depressive symptoms and self-reported food consumption. A population-based study. Appetite. 2010 Jun;54(3):473-9. doi: 10.1016/j.appet.2010.01.014. Epub 2010 Feb 4.

    PubMed 20138944

  • Latner JD, Mond JM, Kelly MC, Haynes SN, Hay PJ. The Loss of Control Over Eating Scale: development and psychometric evaluation. Int J Eat Disord. 2014 Sep;47(6):647-59. doi: 10.1002/eat.22296. Epub 2014 May 26.

    PubMed 24862351

  • Lee PC, Dixon JB. Food for Thought: Reward Mechanisms and Hedonic Overeating in Obesity. Curr Obes Rep. 2017 Dec;6(4):353-361. doi: 10.1007/s13679-017-0280-9.

    PubMed 29052153

  • Lowe MR, Butryn ML. Hedonic hunger: a new dimension of appetite? Physiol Behav. 2007 Jul 24;91(4):432-9. doi: 10.1016/j.physbeh.2007.04.006. Epub 2007 Apr 12.

    PubMed 17531274

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness in people with Emotional Eating, run by McGill University at 2 sites 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 3 inclusion and 6 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 food-related cravings (time frame: Baseline, week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05347914, which also lists 26 linked publications.

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 18 Oct 2023.

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