NCT05101863

Brief Summary

Why in some situations can words soothe our cravings? This research proposal will test the power of self-generated reasons for behavioural change in food addiction, which concerns about three out of ten persons and causes major life hazards such as obesity, diabetes and cancer. While food addiction is becoming more and more frequent in western societies, not much is known about its underlying neurocognitive mechanisms and how to tackle it. This study aims to investigate if and why certain types of affirmation-based therapies such as motivational interviewing (MI) are beneficial for the treatment of food addiction. The working hypothesis proposes that cognitive regulation-based self-control underpins the neurocognitive shift of a patient's willingness to change addictive behaviour, generated by the patient during MI therapy of food addiction. To test this hypothesis this study combines functional magnetic resonance imaging with behavioural testing of dietary decision-making following a participant's change or sustain talk statements. It will compare three groups of participants with and without food addiction and obesity and lean controls. This study will contribute to the improvement of therapies based upon talking oneself in and out of addiction promoting goals. Findings will provide a better understanding of how our everyday life dietary decision-environments prompt good intentions such as improving long-term nutritional quality to actual behaviours such as forgoing immediate desire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

October 19, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2024

Completed
Last Updated

January 12, 2026

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

October 19, 2021

Last Update Submit

January 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • BOLD signal difference between talk types

    contrast in BOLD signal between change and sustain talk in food-addicted obese participants

    30 minutes

Secondary Outcomes (4)

  • BOLD signal difference between talk types and participant groups

    30 minutes

  • Self control during dietary decision-making

    30 minutes

  • Food addiction one month after motivational interviewing

    15 minutes

  • dietary habits one month after motivational interviewing

    15 minutes

Study Arms (3)

Normal-weight, NON-food addicted

Behavioral: Motivational interviewing

obese food addicted

Behavioral: Motivational interviewing

obese NON-food addicted

Behavioral: Motivational interviewing

Interventions

MI is a goal-oriented style of communication, and focuses on resolving a patient's ambivalence, while eliciting his/her own reasons to change addictive behavior, also known as change talk.

Normal-weight, NON-food addictedobese NON-food addictedobese food addicted

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

3 groups: * obese, food addicted participants * obese, NON-food addicted participants * normal-weight, NON-food addicted control participants

You may not qualify if:

  • bad MRI quality
  • drop out

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liane Schmidt

Paris, Île-de-France Region, 75013, France

Location

Related Publications (1)

  • Rodrigues B, Flament B, Khalid I, Rampanana M, Frileux S, Aubertin H, Oppert JM, Fossati P, Koban L, Poitou-Bernert C, Rotge JY, Schmidt L. The neural pathways of change: an fMRI study of the effects of behavioral change suggestions on value-based dietary decision-making. Int J Obes (Lond). 2026 Feb 10. doi: 10.1038/s41366-026-02018-1. Online ahead of print.

Related Links

MeSH Terms

Conditions

Food AddictionObesity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorFeeding and Eating DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 1, 2021

Study Start

September 15, 2022

Primary Completion

September 13, 2024

Study Completion

October 13, 2024

Last Updated

January 12, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations