Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
49 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-06-01
Study Completion Date
2023-08-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Emotional Eating
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Mindfulness
Group Type
EXPERIMENTAL
Mindfulness
Intervention Type
BEHAVIORAL
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.
Interventions
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Mindfulness
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
1. Adults (age \> 18 years) who meet criteria for emotional eating
2. Demonstrate a lack of control over eating
3. High levels of preoccupation with food
2. Demonstrate a lack of control over eating
3. High levels of preoccupation with food
Exclusion Criteria
1. Having been pregnant in the past six months or planning on becoming pregnant in the next year
2. currently undergoing treatment for cancer
3. using medication that affects body weight or appetite
4. being diagnosed with Bulimia Nervosa, Binge Eating Disorder, currently active Major Depression, or other psychiatric illnesses that may affect appetite.
5. Participants must also be proficient in English
6. Own a smartphone
2. currently undergoing treatment for cancer
3. using medication that affects body weight or appetite
4. being diagnosed with Bulimia Nervosa, Binge Eating Disorder, currently active Major Depression, or other psychiatric illnesses that may affect appetite.
5. Participants must also be proficient in English
6. Own a smartphone
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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McGill University
OTHER
Sponsor Role
lead
Responsible Party
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Barbel Knauper
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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McGill University
Montreal, Please Select..., Canada
Site Status
McGill University
Montreal, Quebec, Canada
Site Status
Countries
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Canada
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
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McGillU mindfulness app
Identifier Type: -
Identifier Source: org_study_id
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