Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity

Conditions
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Obesity, Food Addiction

Intervention / Treatment
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* Other: Cognitive and Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive and Behavioural Therapy plus Management as usual<br>12 sessions of CBT during 18 weeks AND management of obesity with nutritional and dietary treatment as usual | Other: Cognitive and Behavioral Therapy<br>* 12 sessions of CBT using a standardized approach<br>|
| No Intervention: Management as usual<br>management of obesity with nutritional and dietary treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Weight/BMI evolution | Weight and height measurement | From baseline, up to 9 months | 
| Evolution of the waist-to-hip ratio | Waist and hip measurement | From baseline, up to 9 months | 
| Evolution of Body Composition | Impedancemetry | From baseline, up to 9 months | 
| Existence and evolution psychiatric and addictive disorders | Mini International Neuropsychiatric Interview 5.0.0 (MINI 5.0.0) | From baseline, up to 18 weeks | 
| Existence and evolution of depression | Beck Depression Inventory (BDI) | From baseline, up to 9 months | 
| Existence and evolution of bulimic hyperphagia | Binge Eating Scale (BES) | From baseline, up to 9 months | 
| Existence and evolution of an alcohol use disorder | Alcohol Use Disorder Inventory Test (AUDIT) | From baseline, up to 9 months | 
| Existence and evolution of a Smoking Disorder | Fagerström Test for Nicotine Dependence (FTND) | From baseline, up to 9 months | 
| Existence and evolution of food cravings | Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) | From baseline, up to 9 months | 
| Existence and evolution of emotional eating | Dutch Eating Behavior Questionnaire (DEBQ) | From baseline, up to 9 months | 
| Evolution of quality of life | Quality of Life, Obesity and Dietetics (QOLOD) | From baseline, up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, food addiction, binge eating disorder, psychiatric disorders, addictive disorders, obesity-specific quality of life, metabolic syndrome, diabetes, dyslipidemia, hypertension, hepatic cytolysis, cognitive and behavioral therapy