Food AddictionAMI+CBTforFANCT04666831
Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction
A study testing Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) in people with Food Addiction and Binge Eating, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
Food addiction is the concept that individuals can be "addicted" to foods, particularly highly processed foods. This concept has attracted growing research interest given rising obesity rates and the engineering of food products. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Addiction, Binge Eating
- What is being tested?
- Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2021to 21 Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria on the modified Yale Food Addiction Scale 2.0 for at least "Mild Food Addiction" (2 symptoms of food addiction and clinical significance)
- Fluent in English
- 18 years or older
- Have access to e-mail
- Have access to high speed internet and Zoom OR telephone
- Have private space to conduct remote therapy sessions
- Must live in the province of Ontario, Canada
Who cannot join
- Current active suicidality or recent psychiatric hospitalizations in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction: A Randomized Controlled Trial
Food addiction is the concept that individuals can be "addicted" to foods, particularly highly processed foods. This concept has attracted growing research interest given rising obesity rates and the engineering of food products. Although food addiction is not a recognized mental disorder, individuals do identify as being addicted to foods and self-help organizations have existed since 1960 to purportedly treat it (i.e., through abstinence). However, little research has been conducted on how abstinence approaches work. Such methods may even be harmful given the risk of disordered eating. Currently, there are no empirically supported treatments for food addiction. However, evidence-based treatments do exist for addictions and eating disorders, such as motivational interviewing and cognitive behavioural therapy, which may prove beneficial for food addiction, given neural similarities between addictions and binge eating.
The current study proposes a randomized controlled trial using a four-session adapted motivational interviewing (AMI) and cognitive behavioural therapy (CBT) intervention for food addiction. This intervention combines the personalized assessment feedback and person-centred counseling of AMI with CBT skills for eating disorders, such as self-monitoring of food intake. The aim is to motivate participants to enact behavioural change, such as reduced and moderate consumption of processed foods. Outcome measures will assess food addiction and binge eating symptoms, self-reported consumption of processed foods, readiness for change, eating self-efficacy, and other constructs such as emotional eating. The intervention condition will be compared to a waitlist control group. Both groups will be assessed at pre- and postintervention periods, as well as over a 3-month follow-up period to assess maintenance effects. Based on a power analysis and previous effect sizes following AMI interventions for binge eating, a total sample size of n = 58 is needed. A total of 131 individuals will be recruited to account for previous exclusion and withdrawal rates. Participation is estimated to take place from March 2021 to March 2022. All intervention sessions will be conducted virtually over secure videoconferencing technology or telephone, expanding access to all adult community members across Ontario, Canada. Twenty randomly selected session tapes will be reviewed for MI adherence.
Read the detailed description
Background: Food addiction is the concept that individuals can be "addicted" to foods, particularly highly processed foods. This concept has attracted growing research interest given rising obesity rates and engineering of food products in industrialized countries. Food addiction is assessed using the validated Yale Food Addiction Scale (YFAS), which applies substance use disorder criteria from the most recent Diagnostic and Statistical Manual of Mental Disorders to the consumption of these types of foods. Prevalence estimates of food addiction range from 8-15% in two nationally representative samples in the U.S. and Germany. Although food addiction is not a currently recognized mental disorder, individuals do identify as being addicted to foods and self-help organizations such as Overeaters Anonymous have existed since 1960 to purportedly treat it (i.e., through abstinence). However, little research has been conducted on how abstinence approaches work and such methods may even be harmful for individuals with eating concerns, given the risk of disordered eating. Currently, there are no empirically supported treatments for food addiction. However, evidence-based treatments do exist for addictions and eating disorders, such as Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT), which may prove beneficial for food addiction, given neural similarities between substance addiction and binge eating, and the potential for high ambivalence. AMI is designed to allow clients to voice their own motivations for change and the use of AMI skills by therapists has been shown in meta-analyses to predict this type of change talk, which then predicts positive behavioural outcomes, Given that food addiction is also associated with internalized weight bias and lower eating self-efficacy, AMI techniques in fostering acceptance, highlighting client strengths, and providing psychoeducation may help to lower self-blame and bolster confidence to change one's eating habits.
Method: The current study proposes a randomized controlled trial using a four-session AMI and CBT intervention for food addiction. Due to COVID-19 limitations, all intervention sessions will be conducted virtually over secure videoconferencing technology or by telephone, expanding access to all adult community members across the province of Ontario in Canada. The intervention combines the personalized assessment feedback and person-centred counselling of AMI with CBT skills for eating disorders, such as self-monitoring of food intake and stimulus control. The aim is to motivate participants to enact behavioural change, such as moderate consumption of processed foods in a harm reduction approach. Twenty randomly selected session tapes will be reviewed by two trained coders to assess for MI adherence using the most commonly used MI fidelity measure. The intervention condition will be compared to a wait-list control (WLC) group. Both groups will be assessed at pre- and postintervention periods, as well as over a 3-month follow-up period to assess maintenance effects.
Hypotheses
Primary Hypotheses - Food Addiction and Binge Eating Frequency (H1-H3)
- H1: Compared to WLC, AMI will lead to a significantly greater reduction in food addiction symptoms (using the YFAS 2.0) at postintervention and up to 3 months postintervention.
- H2: Compared to WLC, AMI will lead to a significantly greater reduction in self-reported consumption of highly processed foods specified in the YFAS 2.0 (using the Canadian Diet History Questionnaire II) at postintervention and up to 3 months postintervention.
- H3: Compared to WLC, AMI will lead a to significantly greater reduction in number of binge eating episodes (using select Eating Disorder Examination Questionnaire questions) at postintervention and up to 3 months postintervention.
Secondary Hypotheses - Readiness for Change, Eating Self-Efficacy, and Weight Bias Internalization (H4-H6)
- H4: Compared to WLC, AMI will lead to a greater increase in motivation for changing one's food addiction symptoms (e.g., reducing consumption of highly processed foods; using Motivational Rulers) at postintervention.
- H5: Compared to WLC, AMI will lead to a significantly greater increase in eating self-efficacy (using the Weight Efficacy Lifestyle Questionnaire) at postintervention.
- H6: Compared to WLC, AMI will lead to a greater reduction in weight bias internalization (using the Modified Weight Bias Internalization Scale) at postintervention.
Secondary Hypotheses - Other Eating-Related Constructs (H7-H14)
It is hypothesized that AMI will lead to significantly greater reductions in other eating-related constructs compared to WLC at postintervention and up to 3 months postintervention, in terms of:
- H7: self-identified food addiction,
- H8: addiction-like eating behaviour (AEBS),
- H9: binge eating symptoms (Binge Eating Scale),
- H10: loss-of-control eating (Loss of Control over Eating Scale),
- H11: emotional eating (Emotional Eating Scale),
- H12: general appetite for palatable foods or hedonic hunger (Power of Food Scale),
- H13: cravings for specific highly processed foods (Food Craving Inventory),
- H14: Body Mass Index (BMI)
Tertiary Hypothesis - Working Alliance (H15-17)
Given that a collaborative partnership is key component of MI and that there is a robust positive association between working alliance and treatment outcomes, it is hypothesized that there will be positive associations between postintervention working alliance (using the Working Alliance Scale Short Form Revised) and postintervention motivation for change (H15), eating self-efficacy (H16), and weight bias internalization (H17).
Sample Size: Based on a power analysis and previous effect sizes following AMI interventions for binge eating (Cohen's d = 0.76), a total sample size of n = 58 is needed. Accounting for previous withdrawal rates and an inclusion rate of 44.6% in a similar study, a total of 131 individuals should be recruited. Recruitment is estimated to take place over 5 months beginning in March 2021. Given the 3-month follow-up, participation is estimated to end in March 2022.
Analyses: To determine whether both AMI and WLC groups are equivalent in terms of sample characteristics as a result of randomization, independent samples t tests will be conducted on baseline variables such as age, BMI, YFAS severity, and binge eating frequency. To determine whether sample characteristics differ between treatment completers and dropouts, independent samples t tests will be conducted on the same baseline variables and working alliance. Lastly, to determine if equal proportions dropped out of the AMI and WLC groups, a chi square test will be conducted.
Primary, Secondary, and Tertiary Outcomes: For the primary outcomes (i.e., YFAS symptoms, binge eating frequency, and consumption of highly processed foods), given the between-groups and repeated-measures mixed design, a 2 (group: WLC vs. AMI) x 4 (time: baseline, postintervention, and 1- and-, 3-month follow-up) mixed analysis of variance (ANOVA) will be conducted on SPSS statistical software. For the secondary outcomes (i.e., readiness for change, eating self-efficacy, and weight bias internalization), a 2 (group: WLC vs. AMI) x 2 (time: baseline, postintervention) mixed ANOVA will be used to compare the WLC and AMI groups from pre- to postintervention. For the other secondary eating-related outcomes, the same 2 (group) x 4 (time) mixed ANOVAs described above will be used to compare WLC and AMI groups across time. For the tertiary outcomes, to determine if there is a positive association between working alliance and readiness for change, eating self-efficacy, and weight bias internalization, two-tailed, bivariate, Pearson's correlation analyses will be performed. To explore the changes in readiness for change, eating self-efficacy, weight bias internalization, and working alliance from pre- to postintervention, paired samples t tests will be used for the AMI group for these four constructs. Prior to data analyses, data will be checked for bias and corrected as necessary. Any interactions from the ANOVAs will be followed up with planned contrasts, with the control group and baseline as the base categories for the between-groups and repeated-measures variables, respectively.
Assuming that there are no valid reasons to ignore missing data and to conduct complete case analysis (e.g., if less than 5% of data are missing), and assuming that data are missing at random, multiple imputation will be conducted on SPSS for the missing values, with at least 50 imputed datasets in order to reduce sampling variability in the imputation process. Results from complete case analyses and multiple imputation analyses will be compared for differences. To reduce bias of the imputation model, the model will include any variables that predict missing data. SPSS will automatically scan the data for a monotone pattern of missing values, and if such a pattern is present, a monotonic multiple imputation will be conducted. The default number of iterations per missing variable used will be 10 but at least 50 imputed datasets will be computed. If data are not assumed to be missing at random, sensitivity analyses will be performed for missing binary data.
Satisfaction Evaluation: Descriptive statistics will be obtained for the three quantitative satisfaction questions (e.g., an average score for how satisfied participants were with the research study). Qualitative responses from the open-ended questions will be analysed as per thematic analysis methodology.
Treatment Adherence: The minimum threshold of MI adherence will be based on the Motivational Interviewing Treatment Integrity Code (MITI) basic competence and proficiency thresholds for clinicians. Specifically, summary scores must fall in at least the "fair" scores (i.e., the Relational score must be 3.5/5, the Technical score must be 3/5, 40% of the reflections must be complex reflections, and the reflection-to-question ratio must be 1:1). If all four domains meet these thresholds, then the session will be rated as 100% fairly adherent, which will be the minimum goal. An average percentage of "fair" adherence across raters and tapes will be calculated to determine if sessions met this threshold. To determine interrater reliability for each summary score, a two-way mixed-effects model, using the mean of two raters (k = 2) and absolute agreement will be used. Intraclass correlation coefficients and their 95% confidence intervals will be reported from the SPSS output.
- Conditions
- Food Addiction, Binge Eating
- Being tested
- Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT)
- Keywords
- food addiction, motivational interviewing, cognitive behavioural therapy, eating disorders, binge eating
- Medical subject headings
- Food Addiction, Bulimia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT)Behavioural
The intervention combines AMI techniques as described by Miller and Rollnick (2013) in the third edition of their Motivational Interviewing book, as well as CBT techniques from the Tele-CBT protocol for bariatric surgery patients by Cassin et al. (2013).
| Study group | Role | What they receive |
|---|---|---|
| AMI and CBT Intervention | Experimental | Participants will receive four weekly sessions of individual therapy (60 minutes) with a graduate student therapist over videoconferencing technology or telephone. The intervention combines Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) techniques for food addiction. Participants will complete questionnaires at baseline, postintervention or 1-month postbaseline, and 2- and 4-months postbaseline. Receives: Behavioral: Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) |
| Waitlist Control | No intervention | Participants will complete questionnaires at baseline, 1-month postbaseline, and 2- and 4-months postbaseline (at timepoints comparable to the intervention arm). They will not receive any intervention during this time. Following the 3-month waitlist, they will cross over into the same procedure as the intervention arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Addiction Symptoms
Measured by the Yale Food Addiction Scale 2.0. Minimum score = 0 symptoms, Maximum score = 11 symptoms. Greater symptoms mean worse outcome.
Measured: Change from baseline to 3 months postintervention
Consumption of Highly Processed Foods
Measured by the Canadian Diet History Questionnaire II. Minimum score = 0. There is no maximum score, as this measures caloric consumption. Higher values mean worse outcome.
Measured: Change from baseline to 3 months postintervention
Binge Eating Frequency
Measured by select Eating Disorder Examination Questionnaire 6.0 questions. Minimum score = 0. There is no maximum as this measures binge eating frequency. Higher values mean worse outcome.
Measured: Change from baseline to 3 months postintervention
Secondary outcomes (12)
Motivation to Change Eating
Measured by MI Motivational Rulers. Minimum score = 0, Maximum score = 30. Higher values mean better outcome.
Measured: Change from baseline and immediately postintervention
Eating Self-Efficacy (confidence to resist the desire to eat in various situations) as assessed by the Weight Efficacy Lifestyle Questionnaire
Measured by the Weight Efficacy Lifestyle Questionnaire. Minimum score = 0, Maximum score = 180. Higher values mean better outcome.
Measured: Change from baseline and immediately postintervention
Weight Bias Internalization
Measured by the Modified Weight Bias Internalization Scale. Minimum score = 11, Maximum score = 77. Higher values mean worse outcome.
Measured: Change from baseline and immediately postintervention
Self-Identified Food Addiction
Measured by two yes/no questions related to self-perceived food addiction. Responses are yes/no (no minimum or maximum scores). Yes means worse outcome.
Measured: Change from baseline to 3 months postintervention
Addiction-like Eating Behaviour
Measured by Addiction-like Eating Behaviour Scale. Minimum score = 15, Maximum score = 75. Higher values mean worse outcome.
Measured: Change from baseline to 3 months postintervention
Binge Eating Symptoms
Measured by Binge Eating Scale. Minimum score = 0, Maximum score = 46. Higher values mean worse outcome.
Measured: Change from baseline to 3 months postintervention
Loss of Control Eating
Measured by Loss of Control over Eating Scale. Minimum score = 7, Maximum score = 35. Higher values mean worse outcome.
Measured: Change from baseline to 3 months postintervention
Emotional Eating
Measured by Emotional Eating Scale. Minimum score = 25, Maximum score = 125. Higher values mean worse outcomes.
Measured: Change from baseline to 3 months postintervention
General Appetite for Palatable Foods or Hedonic Hunger
Measured by Power of Food Scale. Minimum score = 15, Maximum score = 75. Higher values mean worse outcomes.
Measured: Change from baseline to 3 months postintervention
Cravings for Specific Highly Processed Foods
Measured by Food Craving Inventory. Minimum score = 28, Maximum score = 140. Higher values mean worse outcomes.
Measured: Change from baseline to 3 months postintervention
Body Mass Index
Measured by (weight/height^2). There is no minimum or maximum BMI, as it measures weight and height. For the purposes of this study, higher BMI means worse outcome although this is very individual and is not necessarily true in every case.
Measured: Change from baseline to 3 months postintervention
Working Alliance
Measured by Working Alliance Short Form Revised. Minimum score = 12, Maximum score = 60. Higher values mean better outcomes.
Measured: During the intervention (change from session 1 to session 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start7 Mar 2021
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Food AddictionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to an intervention condition (AMI + CBT) or a waitlist control (WLC) group. The WLC group will crossover into the AMI + CBT group following a 3-month waitlist.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Jackman Foundation, BMS Canada Risk Services Ltd., Canadian Psychological Association, Council of Professional Associations of Psychology
- Responsible party
- Principal investigator, Vincent Santiago, MA, Toronto Metropolitan University
- Investigators
- Stephanie E Cassin, PhD, Study director, Toronto Metropolitan UniversityVincent A Santiago, MA, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666831
- Sponsor's protocol ID
- REB 2020-517
- Acronym
- AMI+CBTforFA
- Status last verified
- Nov 2023
- First submitted
- 2 Dec 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing has not yet been decided and is "no" for now.
Publications
Gearhardt AN, Corbin WR, Brownell KD. Development of the Yale Food Addiction Scale Version 2.0. Psychol Addict Behav. 2016 Feb;30(1):113-21. doi: 10.1037/adb0000136.
PubMed 26866783Ifland JR, Preuss HG, Marcus MT, Rourke KM, Taylor WC, Burau K, Jacobs WS, Kadish W, Manso G. Refined food addiction: a classic substance use disorder. Med Hypotheses. 2009 May;72(5):518-26. doi: 10.1016/j.mehy.2008.11.035. Epub 2009 Feb 14.
PubMed 19223127Kramer H. Kidney Disease and the Westernization and Industrialization of Food. Am J Kidney Dis. 2017 Jul;70(1):111-121. doi: 10.1053/j.ajkd.2016.11.012. Epub 2017 Jan 23.
PubMed 28126237Moss, M. (2013, February 20). The extraordinary science of addictive junk food. New York Times Magazine. https://www.nytimes.com/2013/02/24/magazine/the-extraordinary-science-of-junk-food.html
American Psychiatric Association [APA]. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596
Hauck C, Weiss A, Schulte EM, Meule A, Ellrott T. Prevalence of 'Food Addiction' as Measured with the Yale Food Addiction Scale 2.0 in a Representative German Sample and Its Association with Sex, Age and Weight Categories. Obes Facts. 2017;10(1):12-24. doi: 10.1159/000456013. Epub 2017 Feb 11.
PubMed 28190017Schulte EM, Gearhardt AN. Associations of Food Addiction in a Sample Recruited to Be Nationally Representative of the United States. Eur Eat Disord Rev. 2018 Mar;26(2):112-119. doi: 10.1002/erv.2575. Epub 2017 Dec 21.
PubMed 29266583Meadows A, Nolan LJ, Higgs S. Self-perceived food addiction: Prevalence, predictors, and prognosis. Appetite. 2017 Jul 1;114:282-298. doi: 10.1016/j.appet.2017.03.051. Epub 2017 Apr 3.
PubMed 28385581Russell-Mayhew S, von Ranson KM, Masson PC. How does overeaters anonymous help its members? A qualitative analysis. Eur Eat Disord Rev. 2010 Jan;18(1):33-42. doi: 10.1002/erv.966.
PubMed 19827021Schulte EM, Grilo CM, Gearhardt AN. Shared and unique mechanisms underlying binge eating disorder and addictive disorders. Clin Psychol Rev. 2016 Mar;44:125-139. doi: 10.1016/j.cpr.2016.02.001. Epub 2016 Feb 4.
PubMed 26879210Cassin, S. E., Sijercic, I., & Montemarano, V. (2020). Psychosocial interventions for food addiction: A systematic review. Current Addiction Reports, 7, 9-19. https://doi.org/10.1007/s40429-020-00295-y
de Jong M, Schoorl M, Hoek HW. Enhanced cognitive behavioural therapy for patients with eating disorders: a systematic review. Curr Opin Psychiatry. 2018 Nov;31(6):436-444. doi: 10.1097/YCO.0000000000000452.
PubMed 30188385Knowles L, Anokhina A, Serpell L. Motivational interventions in the eating disorders: what is the evidence? Int J Eat Disord. 2013 Mar;46(2):97-107. doi: 10.1002/eat.22053. Epub 2012 Sep 24.
PubMed 23001832Smedslund G, Berg RC, Hammerstrom KT, Steiro A, Leiknes KA, Dahl HM, Karlsen K. Motivational interviewing for substance abuse. Cochrane Database Syst Rev. 2011 May 11;2011(5):CD008063. doi: 10.1002/14651858.CD008063.pub2.
PubMed 21563163Treasure J, Leslie M, Chami R, Fernandez-Aranda F. Are trans diagnostic models of eating disorders fit for purpose? A consideration of the evidence for food addiction. Eur Eat Disord Rev. 2018 Mar;26(2):83-91. doi: 10.1002/erv.2578. Epub 2018 Jan 17.
PubMed 29341400
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04666831
- Acronym / sponsor ID
- AMI+CBTforFA / REB 2020-517
- Conditions
- Food Addiction, Binge Eating
- Keywords
- food addiction, motivational interviewing, cognitive behavioural therapy, eating disorders, binge eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- The Jackman Foundation, BMS Canada Risk Services Ltd., Canadian Psychological Association, Council of Professional Associations of Psychology
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 14 Dec 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.
Food addiction is the concept that individuals can be "addicted" to foods, particularly highly processed foods. This concept has attracted growing research interest given rising obesity rates and the engineering of food products. Although food addiction is not a recognized mental disorder, individuals do identify as being addicted to foods and self-help organizations have existed since 1960 to purportedly treat it (i.e., through abstinence). However, little research has been conducted on how abstinence approaches work. Such methods may even be harmful given the risk of disordered eating. Currently, there are no empirically supported treatments for food addiction. However, evidence-based treatments do exist for addictions and eating disorders, such as motivational interviewing and cognitive behavioural therapy, which may prove beneficial for food addiction, given neural similarities between addictions and binge eating.
The current study proposes a randomized controlled trial using a four-session adapted motivational interviewing (AMI) and cognitive behavioural therapy (CBT) intervention for food addiction. This intervention combines the personalized assessment feedback and person-centred counseling of AMI with CBT skills for eating disorders, such as self-monitoring of food intake. The aim is to motivate participants to enact behavioural change, such as reduced and moderate consumption of processed foods. Outcome measures will assess food addiction and binge eating symptoms, self-reported consumption of processed foods, readiness for change, eating self-efficacy, and other constructs such as emotional eating. The intervention condition will be compared to a waitlist control group. Both groups will be assessed at pre- and postintervention periods, as well as over a 3-month follow-up period to assess maintenance effects. Based on a power analysis and previous effect sizes following AMI interventions for binge eating, a total sample size of n = 58 is needed. A total of 131 individuals will be recruited to account for previous exclusion and withdrawal rates. Participation is estimated to take place from March 2021 to March 2022. All intervention sessions will be conducted virtually over secure videoconferencing technology or telephone, expanding access to all adult community members across Ontario, Canada. Twenty randomly selected session tapes will be reviewed for MI adherence.
Detailed description
Background: Food addiction is the concept that individuals can be "addicted" to foods, particularly highly processed foods. This concept has attracted growing research interest given rising obesity rates and engineering of food products in industrialized countries. Food addiction is assessed using the validated Yale Food Addiction Scale (YFAS), which applies substance use disorder criteria from the most recent Diagnostic and Statistical Manual of Mental Disorders to the consumption of these types of foods. Prevalence estimates of food addiction range from 8-15% in two nationally representative samples in the U.S. and Germany. Although food addiction is not a currently recognized mental disorder, individuals do identify as being addicted to foods and self-help organizations such as Overeaters Anonymous have existed since 1960 to purportedly treat it (i.e., through abstinence). However, little research has been conducted on how abstinence approaches work and such methods may even be harmful for individuals with eating concerns, given the risk of disordered eating. Currently, there are no empirically supported treatments for food addiction. However, evidence-based treatments do exist for addictions and eating disorders, such as Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT), which may prove beneficial for food addiction, given neural similarities between substance addiction and binge eating, and the potential for high ambivalence. AMI is designed to allow clients to voice their own motivations for change and the use of AMI skills by therapists has been shown in meta-analyses to predict this type of change talk, which then predicts positive behavioural outcomes, Given that food addiction is also associated with internalized weight bias and lower eating self-efficacy, AMI techniques in fostering acceptance, highlighting client strengths, and providing psychoeducation may help to lower self-blame and bolster confidence to change one's eating habits.
Method: The current study proposes a randomized controlled trial using a four-session AMI and CBT intervention for food addiction. Due to COVID-19 limitations, all intervention sessions will be conducted virtually over secure videoconferencing technology or by telephone, expanding access to all adult community members across the province of Ontario in Canada. The intervention combines the personalized assessment feedback and person-centred counselling of AMI with CBT skills for eating disorders, such as self-monitoring of food intake and stimulus control. The aim is to motivate participants to enact behavioural change, such as moderate consumption of processed foods in a harm reduction approach. Twenty randomly selected session tapes will be reviewed by two trained coders to assess for MI adherence using the most commonly used MI fidelity measure. The intervention condition will be compared to a wait-list control (WLC) group. Both groups will be assessed at pre- and postintervention periods, as well as over a 3-month follow-up period to assess maintenance effects.
Hypotheses
Primary Hypotheses - Food Addiction and Binge Eating Frequency (H1-H3)
- H1: Compared to WLC, AMI will lead to a significantly greater reduction in food addiction symptoms (using the YFAS 2.0) at postintervention and up to 3 months postintervention.
- H2: Compared to WLC, AMI will lead to a significantly greater reduction in self-reported consumption of highly processed foods specified in the YFAS 2.0 (using the Canadian Diet History Questionnaire II) at postintervention and up to 3 months postintervention.
- H3: Compared to WLC, AMI will lead a to significantly greater reduction in number of binge eating episodes (using select Eating Disorder Examination Questionnaire questions) at postintervention and up to 3 months postintervention.
Secondary Hypotheses - Readiness for Change, Eating Self-Efficacy, and Weight Bias Internalization (H4-H6)
- H4: Compared to WLC, AMI will lead to a greater increase in motivation for changing one's food addiction symptoms (e.g., reducing consumption of highly processed foods; using Motivational Rulers) at postintervention.
- H5: Compared to WLC, AMI will lead to a significantly greater increase in eating self-efficacy (using the Weight Efficacy Lifestyle Questionnaire) at postintervention.
- H6: Compared to WLC, AMI will lead to a greater reduction in weight bias internalization (using the Modified Weight Bias Internalization Scale) at postintervention.
Secondary Hypotheses - Other Eating-Related Constructs (H7-H14)
It is hypothesized that AMI will lead to significantly greater reductions in other eating-related constructs compared to WLC at postintervention and up to 3 months postintervention, in terms of:
- H7: self-identified food addiction,
- H8: addiction-like eating behaviour (AEBS),
- H9: binge eating symptoms (Binge Eating Scale),
- H10: loss-of-control eating (Loss of Control over Eating Scale),
- H11: emotional eating (Emotional Eating Scale),
- H12: general appetite for palatable foods or hedonic hunger (Power of Food Scale),
- H13: cravings for specific highly processed foods (Food Craving Inventory),
- H14: Body Mass Index (BMI)
Tertiary Hypothesis - Working Alliance (H15-17)
Given that a collaborative partnership is key component of MI and that there is a robust positive association between working alliance and treatment outcomes, it is hypothesized that there will be positive associations between postintervention working alliance (using the Working Alliance Scale Short Form Revised) and postintervention motivation for change (H15), eating self-efficacy (H16), and weight bias internalization (H17).
Sample Size: Based on a power analysis and previous effect sizes following AMI interventions for binge eating (Cohen's d = 0.76), a total sample size of n = 58 is needed. Accounting for previous withdrawal rates and an inclusion rate of 44.6% in a similar study, a total of 131 individuals should be recruited. Recruitment is estimated to take place over 5 months beginning in March 2021. Given the 3-month follow-up, participation is estimated to end in March 2022.
Analyses: To determine whether both AMI and WLC groups are equivalent in terms of sample characteristics as a result of randomization, independent samples t tests will be conducted on baseline variables such as age, BMI, YFAS severity, and binge eating frequency. To determine whether sample characteristics differ between treatment completers and dropouts, independent samples t tests will be conducted on the same baseline variables and working alliance. Lastly, to determine if equal proportions dropped out of the AMI and WLC groups, a chi square test will be conducted.
Primary, Secondary, and Tertiary Outcomes: For the primary outcomes (i.e., YFAS symptoms, binge eating frequency, and consumption of highly processed foods), given the between-groups and repeated-measures mixed design, a 2 (group: WLC vs. AMI) x 4 (time: baseline, postintervention, and 1- and-, 3-month follow-up) mixed analysis of variance (ANOVA) will be conducted on SPSS statistical software. For the secondary outcomes (i.e., readiness for change, eating self-efficacy, and weight bias internalization), a 2 (group: WLC vs. AMI) x 2 (time: baseline, postintervention) mixed ANOVA will be used to compare the WLC and AMI groups from pre- to postintervention. For the other secondary eating-related outcomes, the same 2 (group) x 4 (time) mixed ANOVAs described above will be used to compare WLC and AMI groups across time. For the tertiary outcomes, to determine if there is a positive association between working alliance and readiness for change, eating self-efficacy, and weight bias internalization, two-tailed, bivariate, Pearson's correlation analyses will be performed. To explore the changes in readiness for change, eating self-efficacy, weight bias internalization, and working alliance from pre- to postintervention, paired samples t tests will be used for the AMI group for these four constructs. Prior to data analyses, data will be checked for bias and corrected as necessary. Any interactions from the ANOVAs will be followed up with planned contrasts, with the control group and baseline as the base categories for the between-groups and repeated-measures variables, respectively.
Assuming that there are no valid reasons to ignore missing data and to conduct complete case analysis (e.g., if less than 5% of data are missing), and assuming that data are missing at random, multiple imputation will be conducted on SPSS for the missing values, with at least 50 imputed datasets in order to reduce sampling variability in the imputation process. Results from complete case analyses and multiple imputation analyses will be compared for differences. To reduce bias of the imputation model, the model will include any variables that predict missing data. SPSS will automatically scan the data for a monotone pattern of missing values, and if such a pattern is present, a monotonic multiple imputation will be conducted. The default number of iterations per missing variable used will be 10 but at least 50 imputed datasets will be computed. If data are not assumed to be missing at random, sensitivity analyses will be performed for missing binary data.
Satisfaction Evaluation: Descriptive statistics will be obtained for the three quantitative satisfaction questions (e.g., an average score for how satisfied participants were with the research study). Qualitative responses from the open-ended questions will be analysed as per thematic analysis methodology.
Treatment Adherence: The minimum threshold of MI adherence will be based on the Motivational Interviewing Treatment Integrity Code (MITI) basic competence and proficiency thresholds for clinicians. Specifically, summary scores must fall in at least the "fair" scores (i.e., the Relational score must be 3.5/5, the Technical score must be 3/5, 40% of the reflections must be complex reflections, and the reflection-to-question ratio must be 1:1). If all four domains meet these thresholds, then the session will be rated as 100% fairly adherent, which will be the minimum goal. An average percentage of "fair" adherence across raters and tapes will be calculated to determine if sessions met this threshold. To determine interrater reliability for each summary score, a two-way mixed-effects model, using the mean of two raters (k = 2) and absolute agreement will be used. Intraclass correlation coefficients and their 95% confidence intervals will be reported from the SPSS output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to an intervention condition (AMI + CBT) or a waitlist control (WLC) group. The WLC group will crossover into the AMI + CBT group following a 3-month waitlist.
| Arm | Type | Receives |
|---|---|---|
| AMI and CBT Intervention | Experimental | Behavioral: Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT)Participants will receive four weekly sessions of individual therapy (60 minutes) with a graduate student therapist over videoconferencing technology or telephone. The intervention combines Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) techniques for food addiction. Participants will complete questionnaires at baseline, postintervention or 1-month postbaseline, and 2- and 4-months postbaseline. |
| Waitlist Control | No intervention | –Participants will complete questionnaires at baseline, 1-month postbaseline, and 2- and 4-months postbaseline (at timepoints comparable to the intervention arm). They will not receive any intervention during this time. Following the 3-month waitlist, they will cross over into the same procedure as the intervention arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meets criteria on the modified Yale Food Addiction Scale 2.0 for at least "Mild Food Addiction" (2 symptoms of food addiction and clinical significance)
- Fluent in English
- 18 years or older
- Have access to e-mail
- Have access to high speed internet and Zoom OR telephone
Key exclusion criteria (1 listed)
- Current active suicidality or recent psychiatric hospitalizations in the past 6 months
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 |
|---|---|---|
| Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT)The intervention combines AMI techniques as described by Miller and Rollnick (2013) in the third edition of their Motivational Interviewing book, as well as CBT techniques from the Tele-CBT protocol for bariatric surgery patients by Cassin et al. (2013). | Behavioural | AMI and CBT Intervention |
Primary outcome
Food Addiction Symptoms
Time frame: Change from baseline to 3 months postintervention
Measured by the Yale Food Addiction Scale 2.0. Minimum score = 0 symptoms, Maximum score = 11 symptoms. Greater symptoms mean worse outcome.
Consumption of Highly Processed Foods
Time frame: Change from baseline to 3 months postintervention
Measured by the Canadian Diet History Questionnaire II. Minimum score = 0. There is no maximum score, as this measures caloric consumption. Higher values mean worse outcome.
Binge Eating Frequency
Time frame: Change from baseline to 3 months postintervention
Measured by select Eating Disorder Examination Questionnaire 6.0 questions. Minimum score = 0. There is no maximum as this measures binge eating frequency. Higher values mean worse outcome.
12 secondary outcomes
Motivation to Change Eating
Time frame: Change from baseline and immediately postintervention
Eating Self-Efficacy (confidence to resist the desire to eat in various situations) as assessed by the Weight Efficacy Lifestyle Questionnaire
Time frame: Change from baseline and immediately postintervention
Weight Bias Internalization
Time frame: Change from baseline and immediately postintervention
Self-Identified Food Addiction
Time frame: Change from baseline to 3 months postintervention
Addiction-like Eating Behaviour
Time frame: Change from baseline to 3 months postintervention
Binge Eating Symptoms
Time frame: Change from baseline to 3 months postintervention
Loss of Control Eating
Time frame: Change from baseline to 3 months postintervention
Emotional Eating
Time frame: Change from baseline to 3 months postintervention
General Appetite for Palatable Foods or Hedonic Hunger
Time frame: Change from baseline to 3 months postintervention
Cravings for Specific Highly Processed Foods
Time frame: Change from baseline to 3 months postintervention
Body Mass Index
Time frame: Change from baseline to 3 months postintervention
Working Alliance
Time frame: During the intervention (change from session 1 to session 4)
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 22 Nov 2023.
- Background: PubMed 26866783Gearhardt AN, Corbin WR, Brownell KD. Development of the Yale Food Addiction Scale Version 2.0. Psychol Addict Behav. 2016 Feb;30(1):113-21. doi: 10.1037/adb0000136.
- Background: PubMed 19223127Ifland JR, Preuss HG, Marcus MT, Rourke KM, Taylor WC, Burau K, Jacobs WS, Kadish W, Manso G. Refined food addiction: a classic substance use disorder. Med Hypotheses. 2009 May;72(5):518-26. doi: 10.1016/j.mehy.2008.11.035. Epub 2009 Feb 14.
- Background: PubMed 28126237Kramer H. Kidney Disease and the Westernization and Industrialization of Food. Am J Kidney Dis. 2017 Jul;70(1):111-121. doi: 10.1053/j.ajkd.2016.11.012. Epub 2017 Jan 23.
- BackgroundMoss, M. (2013, February 20). The extraordinary science of addictive junk food. New York Times Magazine. https://www.nytimes.com/2013/02/24/magazine/the-extraordinary-science-of-junk-food.html
- BackgroundAmerican Psychiatric Association [APA]. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596
- Background: PubMed 28190017Hauck C, Weiss A, Schulte EM, Meule A, Ellrott T. Prevalence of 'Food Addiction' as Measured with the Yale Food Addiction Scale 2.0 in a Representative German Sample and Its Association with Sex, Age and Weight Categories. Obes Facts. 2017;10(1):12-24. doi: 10.1159/000456013. Epub 2017 Feb 11.
- Background: PubMed 29266583Schulte EM, Gearhardt AN. Associations of Food Addiction in a Sample Recruited to Be Nationally Representative of the United States. Eur Eat Disord Rev. 2018 Mar;26(2):112-119. doi: 10.1002/erv.2575. Epub 2017 Dec 21.
- Background: PubMed 28385581Meadows A, Nolan LJ, Higgs S. Self-perceived food addiction: Prevalence, predictors, and prognosis. Appetite. 2017 Jul 1;114:282-298. doi: 10.1016/j.appet.2017.03.051. Epub 2017 Apr 3.
- Background: PubMed 19827021Russell-Mayhew S, von Ranson KM, Masson PC. How does overeaters anonymous help its members? A qualitative analysis. Eur Eat Disord Rev. 2010 Jan;18(1):33-42. doi: 10.1002/erv.966.
- Background: PubMed 26879210Schulte EM, Grilo CM, Gearhardt AN. Shared and unique mechanisms underlying binge eating disorder and addictive disorders. Clin Psychol Rev. 2016 Mar;44:125-139. doi: 10.1016/j.cpr.2016.02.001. Epub 2016 Feb 4.
- BackgroundCassin, S. E., Sijercic, I., & Montemarano, V. (2020). Psychosocial interventions for food addiction: A systematic review. Current Addiction Reports, 7, 9-19. https://doi.org/10.1007/s40429-020-00295-y
- Background: PubMed 30188385de Jong M, Schoorl M, Hoek HW. Enhanced cognitive behavioural therapy for patients with eating disorders: a systematic review. Curr Opin Psychiatry. 2018 Nov;31(6):436-444. doi: 10.1097/YCO.0000000000000452.
- Individual participant dataSharing planned: No. IPD sharing has not yet been decided and is "no" for now.
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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.
Stephanie E Cassin, PhD study director
Toronto Metropolitan University
Vincent A Santiago, MA principal investigator
Toronto Metropolitan 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 Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) in people with Food Addiction and Binge Eating, run by Toronto Metropolitan 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 7 inclusion and 1 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 22 Nov 2023. 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?
Food Addiction Symptoms (time frame: Change from baseline to 3 months postintervention). The study lists 3 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 NCT04666831, which also lists 34 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 22 Nov 2023.