Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666831
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2020-12-02
Brief Title:
Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction
Sponsor:
Toronto Metropolitan University
Organization:
Toronto Metropolitan University
Study Overview
Official Title:
Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMICBTforFA
Brief 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 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 ie 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
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 US 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 ie 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 ones 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 20 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 20 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 ones food addiction symptoms eg 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 Cohens d 076 a total sample size of n 58 is needed Accounting for previous withdrawal rates and an inclusion rate of 446 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 ie 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 ie 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 Pearsons 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 eg 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 eg 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 ie the Relational score must be 355 the Technical score must be 35 40 of the reflections must be complex reflections and the reflection-to-question ratio must be 11 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
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 20 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 20 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 ones food addiction symptoms eg 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 Cohens d 076 a total sample size of n 58 is needed Accounting for previous withdrawal rates and an inclusion rate of 446 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 ie 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 ie 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 Pearsons 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 eg 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 eg 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 ie the Relational score must be 355 the Technical score must be 35 40 of the reflections must be complex reflections and the reflection-to-question ratio must be 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None