NCT04626570Completed
Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
Morbid or severe obesity is a chronic pathology of multifactorial etiology that affects 4.3% of the French population. In these patients, eating disorders are frequent and must be managed as they are considered risk factors with poorer weight prognosis and lower quality of life. Some authors have proposed that the concept of food addiction (i.e., the existence of an addiction to certain foods rich in sugar, fat and/or salt) may make it possible to identify, among obese patients, a subgroup of patients that is more homogeneous in terms of diagnosis and prognosis. Food addiction is common in obese patients and is associated with higher levels of depression, anxiety, impulsivity, emotional eating and poorer quality of life. Nevertheless, we do not know the impact of managing this addiction on the future of these patients (food addiction, weight, comorbidities, quality of life). Telephone-based cognitive behavioral therapy intervention (Tele-CBT) is a treatment of choice for addictions, but there are inequalities in access to this treatment (distance between home and hospital, limited local resources of caregivers, constraints in patient availability) which require the therapeutic framework to be adapted to these constraints. A short Tele-CBT program has demonstrated its effectiveness in reducing bulimic hyperphagia in these patients (Cassin et al. 2016), but its effectiveness on food addiction, Body Mass Index and the evolution of metabolic complications related to obesity is still unknown. The evaluation of this program was limited to 6 weeks (American study), and we do not know if these results can also be extrapolated to France. The main hypothesis of this study is that in patients suffering from severe or morbid obesity and with food addiction, the performance of tele-CBT (intervention group: 12 sessions for 18 weeks) will be accompanied by a significant medium-term decrease in the prevalence of food addiction compared to usual management (control group).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 154 (actual)
- First submitted
- 10 Nov 2020
- Start date
- 20 Jan 2021
- Primary completion date
- 3 Mar 2025
- Lead sponsor
- University Hospital, Tours
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT04626570
What you commit to
- Study type: Interventional
- Participants enrolled: 154
- From 20 Jan 2021 to the primary completion date, 3 Mar 2025
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Not eligible for CBT (i.e., cognitive disorders, hearing disorders)
- Severe alcohol use disorder (at least 6 out of 11 DSM-5 criteria for alcohol use disorder)
- Condition associated with important weight variations (i.e., oedema related to severe cardiac insufficiency, renal insufficiency, hepatic insufficiency with cirrhosis, exudative enteropathy)
Other
- Difficulties in understanding the self-administered questionnaires, including illiteracy
- Impossibility to participate to the CBT sessions (i.e., no phone, scheduled unavailability)
- Antecedent of monogenic or oligogenic obesity (MC4R mutation)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of endocrinology-diabetology-nutrition, University Hospital, Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Nutrition Department, University Hospital, Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Transversal Clinical Nutrition Unit, University Hospital, Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Transversal Nutrition Unit, Hospital, Cherbourg Coordinator of this site? Confirm its status | Cherbourg | France | Unknown status |
| Nutrition Department, University Hospital, Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Endocrinology, diabetology and nutrition department, University Hospital, Reims Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Endocrinology, diabetology and nutrition department, University Hospital, Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Metabolic and nutritional exploration, University Hospital, Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.