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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04626570
Other study ID # DR190068
Secondary ID 2019-A02773-54
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2021
Est. completion date January 2025

Study information

Verified date November 2023
Source University Hospital, Tours
Contact Paul BRUNAULT, MD
Phone 0218370581
Email paul.brunault@univ-tours.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 154
Est. completion date January 2025
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cognitive and Behavioral Therapy
12 sessions of CBT using a standardized approach

Locations

Country Name City State
France Department of endocrinology-diabetology-nutrition, University Hospital, Angers Angers
France Nutrition Department, University Hospital, Brest Brest
France Transversal Clinical Nutrition Unit, University Hospital, Caen Caen
France Transversal Nutrition Unit, Hospital, Cherbourg Cherbourg
France Nutrition Department, University Hospital, Nantes Nantes
France Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers Poitiers
France Endocrinology, diabetology and nutrition department, University Hospital, Reims Reims
France Endocrinology, diabetology and nutrition department, University Hospital, Rennes Rennes
France Metabolic and nutritional exploration, University Hospital, Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients without food addiction Yale Food Addiction Scale 2.0 (food addiction is defined by the existence of at least 2 out of 11 criteria for food addiction and associated emotional distress) 18 weeks after randomization
Secondary Evolution of Percentage of patients without food addiction during follow-up Yale Food Addiction Scale 2.0 (food addiction is defined by the existence of at least 2 out of 11 criteria for food addiction and associated emotional distress) From baseline, up to 9 months
Secondary Evolution of number of criteria for food addiction Yale Food Addiction Scale 2.0 (food addiction is defined by the existence of at least 2 out of 11 criteria for food addiction and associated emotional distress) From baseline, up to 9 months
Secondary Weight/BMI evolution Weight and height measurement From baseline, up to 9 months
Secondary Evolution of the waist-to-hip ratio Waist and hip measurement From baseline, up to 9 months
Secondary Evolution of Body Composition Impedancemetry From baseline, up to 9 months
Secondary Existence and evolution psychiatric and addictive disorders Mini International Neuropsychiatric Interview 5.0.0 (MINI 5.0.0) From baseline, up to 18 weeks
Secondary Existence and evolution of depression Beck Depression Inventory (BDI) From baseline, up to 9 months
Secondary Existence and evolution of bulimic hyperphagia Binge Eating Scale (BES) From baseline, up to 9 months
Secondary Existence and evolution of an alcohol use disorder Alcohol Use Disorder Inventory Test (AUDIT) From baseline, up to 9 months
Secondary Existence and evolution of a Smoking Disorder Fagerström Test for Nicotine Dependence (FTND) From baseline, up to 9 months
Secondary Existence and evolution of food cravings Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) From baseline, up to 9 months
Secondary Existence and evolution of emotional eating Dutch Eating Behavior Questionnaire (DEBQ) From baseline, up to 9 months
Secondary Evolution of quality of life Quality of Life, Obesity and Dietetics (QOLOD) From baseline, up to 9 months
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