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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02773-54 | Other Identifier | IdRCB |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive and Behavioural Therapy plus Management as usual | Experimental | 12 sessions of CBT during 18 weeks AND management of obesity with nutritional and dietary treatment as usual |
|
| Management as usual | No Intervention | management of obesity with nutritional and dietary treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive and Behavioral Therapy | Other | 12 sessions of CBT using a standardized approach |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul BRUNAULT, MD | University Hospital, Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of endocrinology-diabetology-nutrition, University Hospital, Angers | Angers | 49933 | France | |||
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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 |
| Nutrition Department, University Hospital, Brest |
| Brest |
| 29609 |
| France |
| Transversal Clinical Nutrition Unit, University Hospital, Caen | Caen | 14033 | France |
| Transversal Nutrition Unit, Hospital, Cherbourg | Cherbourg | 50100 | France |
| Nutrition Department, University Hospital, Nantes | Nantes | 44093 | France |
| Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers | Poitiers | 86000 | France |
| Endocrinology, diabetology and nutrition department, University Hospital, Reims | Reims | 51092 | France |
| Endocrinology, diabetology and nutrition department, University Hospital, Rennes | Rennes | 35033 | France |
| Metabolic and nutritional exploration, University Hospital, Tours | Tours | 37044 | France |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000073932 | Food Addiction |
| D056912 | Binge-Eating Disorder |
| D001523 | Mental Disorders |
| D024821 | Metabolic Syndrome |
| D003920 | Diabetes Mellitus |
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D001068 | Feeding and Eating Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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