Clinical trial NCT04626570: Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity
Official title: Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Food Addiction
Keywords: 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
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Percentage of patients without food addiction
timeFrame: 18 weeks after randomization
Secondary outcomes:
measure: Evolution of Percentage of patients without food addiction during follow-up
timeFrame: From baseline, up to 9 months
measure: Evolution of number of criteria for food addiction
timeFrame: From baseline, up to 9 months
measure: Weight/BMI evolution
timeFrame: From baseline, up to 9 months
measure: Evolution of the waist-to-hip ratio
timeFrame: From baseline, up to 9 months
measure: Evolution of Body Composition
timeFrame: From baseline, up to 9 months
measure: Existence and evolution psychiatric and addictive disorders
timeFrame: From baseline, up to 18 weeks
measure: Existence and evolution of depression
timeFrame: From baseline, up to 9 months
measure: Existence and evolution of bulimic hyperphagia
timeFrame: From baseline, up to 9 months
measure: Existence and evolution of an alcohol use disorder
timeFrame: From baseline, up to 9 months
measure: Existence and evolution of a Smoking Disorder
timeFrame: From baseline, up to 9 months
measure: Existence and evolution of food cravings
timeFrame: From baseline, up to 9 months
measure: Existence and evolution of emotional eating
timeFrame: From baseline, up to 9 months
measure: Evolution of quality of life
timeFrame: From baseline, up to 9 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Department of endocrinology-diabetology-nutrition, University Hospital, Angers
city: Brest
country: France
facility: Nutrition Department, University Hospital, Brest
city: Caen
country: France
facility: Transversal Clinical Nutrition Unit, University Hospital, Caen
city: Cherbourg
country: France
facility: Transversal Nutrition Unit, Hospital, Cherbourg
city: Nantes
country: France
facility: Nutrition Department, University Hospital, Nantes
city: Poitiers
country: France
facility: Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers
city: Reims
country: France
facility: Endocrinology, diabetology and nutrition department, University Hospital, Reims
city: Rennes
country: France
facility: Endocrinology, diabetology and nutrition department, University Hospital, Rennes
city: Tours
country: France
facility: Metabolic and nutritional exploration, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Paul BRUNAULT, MD
role: STUDY_DIRECTOR
References: