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NCT04666831: AMI+CBTforFA
Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction
NA trial testing Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) in Food Addiction in 94 participants. Completed in 21 January 2023.
21 January 2023
Quick facts
| Lead sponsor | Toronto Metropolitan University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 94 |
| Start date | 7 March 2021 |
| Primary completion | 21 January 2023 |
| Estimated completion | 21 January 2023 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT)
Conditions studied
- Food Addiction — all drugs for Food Addiction →
- Binge Eating — all drugs for Binge Eating →
Sponsor
Toronto Metropolitan University
Who can join
18 and older, any sex, with Food Addiction or Binge Eating. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The MotivATE randomized controlled trial: treating food addiction with adapted motivational interviewing and cognitive behavioural therapy versus a waitlist control condition.
Santiago VA, Cassin SE. · · 2026 · PMID 41582183 · DOI 10.1186/s40337-025-01522-5
Verify or expand the search:
- PubMed search for NCT04666831
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06030362 — Probiotic Intervention Study · NA · recruiting
- NCT05437809 — Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods · NA · recruiting
Other Toronto Metropolitan University trials
Trials by the same sponsor.
- NCT07494604 — The Role of Solo Music Listening in Reducing Loneliness and Increasing Social Connectedness in Older Adults · NA · not yet recruiting
- NCT07231133 — Effect of Within-Meal Consumption of Allulose on Diet-induced Thermogenesis · NA · completed
- NCT06083519 — Assessment of a Novel Sound-based Treatment for Managing Distress Related to Tinnitus · NA · recruiting
- NCT05442086 — Music and ABS as a Potential Anxiety Intervention · NA · completed
- NCT06515340 — Effect of Allulose on Diet-induced Thermogenesis · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04666831 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Toronto Metropolitan University
- Last refreshed: 22 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04666831.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing