FMRI of Dietary Decision-making in Food Addicted Participants Compared to Non-food Addicted Parti… (NCT05101863) | Clinical Trial Compass
CompletedNot Applicable
FMRI of Dietary Decision-making in Food Addicted Participants Compared to Non-food Addicted Participants
France56 participantsStarted 2022-09-15
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Group: Normal-weight, NON-food addicted control participants
* no food addiction, no eating disorder, no nutrition troubles, no weight management troubles
* BMI: between 18.5 kg/m2 and 25 kg/m2
* age 18 to 70 years
* right-handed
* male / female
* able to understand instructions and perform tasks
* no psychiatric or neurological disorders
* no drug abuse
* written and informed consent
Group: obese, food addicted
* BMI \>= 30 kg/m2
* YFAS score \> = 2
* no other addictions
* age 18 to 70 years
* right-handed
* male / female
* able to understand instructions and perform tasks
* no recently diagnosed psychiatric or neurological disorders
* no drug abuse
* written and informed consent
Group: obese, NON-food addicted
* age 18 to 70 years
* BMI \>= 30 kg/m2
* YFAS score \< =1
* no other addictions
* right-handed
* male / female
* able to understand instructions and perform tasks
* no recently diagnosed psychiatric or neurological disorders
* no drug abuse
* written and informed consent
Exclusion Criteria:
* bad MRI quality
* drop out
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
BOLD signal difference between talk types
Timeframe: 30 minutes
Trial details
NCT IDNCT05101863
SponsorInstitut National de la Santé Et de la Recherche Médicale, France