Phone-based therapy for food addiction in severely obese patients
Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity
This study tests whether a phone-based therapy can help severely obese people with food addiction improve their eating habits and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT04626570 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a telephone-based cognitive behavioral therapy (Tele-CBT) program aimed at treating food addiction in patients with severe or morbid obesity. It targets individuals diagnosed with food addiction, which is linked to higher levels of depression, anxiety, and emotional eating. The intervention seeks to improve patients' quality of life, weight management, and metabolic health by addressing the psychological aspects of their eating behaviors. Participants will be monitored for changes in food addiction symptoms, body mass index, and related health complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a BMI of 35 or higher who have been diagnosed with food addiction.
Not a fit: Patients with cognitive disorders, severe alcohol use disorder, or those unable to participate in phone sessions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and weight management for patients struggling with food addiction.
How similar studies have performed: Previous studies have shown that Tele-CBT can effectively reduce binge eating behaviors, suggesting potential for success in this novel application for food addiction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-65 years * BMI ≥35kg/m² (morbid or severe obesity) * First appointment to a physician specialized in nutrition * "Food addiction diagnosis" according to the YFAS 2.0 * Affiliated to the French national health service * Consent signed Exclusion Criteria: * Difficulties in understanding the self-administered questionnaires, including illiteracy * Impossibility to participate to the CBT sessions (i.e., no phone, scheduled unavailability) * Not eligible for CBT (i.e., cognitive disorders, hearing disorders) * Antecedent of monogenic or oligogenic obesity (MC4R mutation) * Severe alcohol use disorder (at least 6 out of 11 DSM-5 criteria for alcohol use disorder) * Current medication with a significant adverse effect on eating behavior (i.e., lithium, neuroleptic/antipsychotic) * Discrepancy between self-administered questionnaires and the clinical interview conducted prior to inclusion (for the assessment of food addiction diagnosis). * Condition associated with important weight variations (i.e., oedema related to severe cardiac insufficiency, renal insufficiency, hepatic insufficiency with cirrhosis, exudative enteropathy) * Participation to another psychological or pharmacological interventional study that could impact our primary or secondary outcomes * Wearing a pace-maker or metal prosthesis * Person under tutorship or curatorship
Where this trial is running
Angers and 8 other locations
- Department of endocrinology-diabetology-nutrition, University Hospital, Angers — Angers, France (Recruiting)
- Nutrition Department, University Hospital, Brest — Brest, France (Recruiting)
- Transversal Clinical Nutrition Unit, University Hospital, Caen — Caen, France (Recruiting)
- Transversal Nutrition Unit, Hospital, Cherbourg — Cherbourg, France (Recruiting)
- Nutrition Department, University Hospital, Nantes — Nantes, France (Recruiting)
- Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers — Poitiers, France (Recruiting)
- Endocrinology, diabetology and nutrition department, University Hospital, Reims — Reims, France (Recruiting)
- Endocrinology, diabetology and nutrition department, University Hospital, Rennes — Rennes, France (Recruiting)
- Metabolic and nutritional exploration, University Hospital, Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Paul BRUNAULT, MD
- Email: paul.brunault@univ-tours.fr
- Phone: 0218370581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.