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

NCT ID: NCT04626570

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2025-07-25

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).

Conditions

Obesity; Food Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive and Behavioural Therapy plus Management as usual

12 sessions of CBT during 18 weeks AND management of obesity with nutritional and dietary treatment as usual

Group Type: EXPERIMENTAL

Cognitive and Behavioral Therapy

Intervention Type: OTHER

12 sessions of CBT using a standardized approach

Management as usual

management of obesity with nutritional and dietary treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive and Behavioral Therapy

12 sessions of CBT using a standardized approach

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul BRUNAULT, MD

Role: STUDY_DIRECTOR

University Hospital, Tours

Locations

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, , France

Countries

France

Other Identifiers

2019-A02773-54

Identifier Type: OTHER

Identifier Source: secondary_id

DR190068

Identifier Type: -

Identifier Source: org_study_id