NCT05347914

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 16, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

April 16, 2022

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    Baseline, week 6

  • 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)

    Baseline, week 6

Secondary Outcomes (5)

  • Change in feelings of control around eating

    Baseline, week 6

  • Change in overidentification with food cravings

    Baseline, week 6

  • Change in reactivity towards eating related experiences

    Baseline, week 6

  • Change in judgment towards eating related experiences

    Baseline, week 6

  • Change in capacity to tolerate distress

    Baseline, week 6

Study Arms (1)

Mindfulness

EXPERIMENTAL
Behavioral: Mindfulness

Interventions

MindfulnessBEHAVIORAL

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.

Mindfulness

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McGill University

Montreal, Please Select..., H3A 1G1, Canada

Location

McGill University

Montreal, Quebec, H3A 1G1, Canada

Location

Related Publications (26)

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    PMID: 19844211BACKGROUND
  • 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.

    PMID: 30250438BACKGROUND
  • 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.

    PMID: 19506564BACKGROUND
  • 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.

    PMID: 34517074BACKGROUND
  • 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.

    PMID: 18708140BACKGROUND
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    PMID: 26946280BACKGROUND
  • 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.

    PMID: 33670147BACKGROUND
  • 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.

    PMID: 24979216BACKGROUND
  • 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.

    PMID: 17723034BACKGROUND
  • 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.

    PMID: 20138944BACKGROUND
  • 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.

    PMID: 24862351BACKGROUND
  • 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.

    PMID: 29052153BACKGROUND
  • 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.

    PMID: 17531274BACKGROUND
  • Meule A, Teran CB, Berker J, Grundel T, Mayerhofer M, Platte P. On the differentiation between trait and state food craving: Half-year retest-reliability of the Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) and the Food Cravings Questionnaire-State (FCQ-S). J Eat Disord. 2014 Sep 6;2(1):25. doi: 10.1186/s40337-014-0025-z. eCollection 2014.

    PMID: 25356313BACKGROUND
  • Ozier AD, Kendrick OW, Leeper JD, Knol LL, Perko M, Burnham J. Overweight and obesity are associated with emotion- and stress-related eating as measured by the eating and appraisal due to emotions and stress questionnaire. J Am Diet Assoc. 2008 Jan;108(1):49-56. doi: 10.1016/j.jada.2007.10.011.

    PMID: 18155989BACKGROUND
  • Papachristou H, Nederkoorn C, Beunen S, Jansen A. Dissection of appetitive conditioning. Does impulsivity play a role? Appetite. 2013 Oct;69:46-53. doi: 10.1016/j.appet.2013.05.011. Epub 2013 May 23.

    PMID: 23707358BACKGROUND
  • Sinha R, Jastreboff AM. Stress as a common risk factor for obesity and addiction. Biol Psychiatry. 2013 May 1;73(9):827-35. doi: 10.1016/j.biopsych.2013.01.032. Epub 2013 Mar 26.

    PMID: 23541000BACKGROUND
  • Sung J, Lee K, Song YM. Relationship of eating behavior to long-term weight change and body mass index: the Healthy Twin study. Eat Weight Disord. 2009 Jun-Sep;14(2-3):e98-105. doi: 10.1007/BF03327806.

    PMID: 19934643BACKGROUND
  • Stice E, Burger K. Neural vulnerability factors for obesity. Clin Psychol Rev. 2019 Mar;68:38-53. doi: 10.1016/j.cpr.2018.12.002. Epub 2018 Dec 19.

    PMID: 30587407BACKGROUND
  • Steward T, Menchon JM, Jimenez-Murcia S, Soriano-Mas C, Fernandez-Aranda F. Neural Network Alterations Across Eating Disorders: A Narrative Review of fMRI Studies. Curr Neuropharmacol. 2018;16(8):1150-1163. doi: 10.2174/1570159X15666171017111532.

    PMID: 29046154BACKGROUND
  • Tomiyama AJ, Dallman MF, Epel ES. Comfort food is comforting to those most stressed: evidence of the chronic stress response network in high stress women. Psychoneuroendocrinology. 2011 Nov;36(10):1513-9. doi: 10.1016/j.psyneuen.2011.04.005. Epub 2011 Sep 8.

    PMID: 21906885BACKGROUND
  • Van Gucht D, Baeyens F, Hermans D, Beckers T. The inertia of conditioned craving. Does context modulate the effect of counterconditioning? Appetite. 2013 Jun;65:51-7. doi: 10.1016/j.appet.2013.01.019. Epub 2013 Feb 10.

    PMID: 23402718BACKGROUND
  • van Strien T, Herman CP, Verheijden MW. Eating style, overeating and weight gain. A prospective 2-year follow-up study in a representative Dutch sample. Appetite. 2012 Dec;59(3):782-9. doi: 10.1016/j.appet.2012.08.009. Epub 2012 Aug 20.

    PMID: 22918175BACKGROUND
  • Ziauddeen H, Farooqi IS, Fletcher PC. Obesity and the brain: how convincing is the addiction model? Nat Rev Neurosci. 2012 Mar 14;13(4):279-86. doi: 10.1038/nrn3212.

    PMID: 22414944BACKGROUND

MeSH Terms

Conditions

Emotional Eating

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

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
Professor

Study Record Dates

First Submitted

April 16, 2022

First Posted

April 26, 2022

Study Start

June 1, 2022

Primary Completion

August 28, 2023

Study Completion

August 28, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations