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

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Food Addiction
• Intervention / Treatment: Other: Cognitive and Behavioral Therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Department of endocrinology-diabetology-nutrition, University Hospital, Angers
  • Brest, France, 29609
    • Nutrition Department, University Hospital, Brest
  • Caen, France, 14033
    • Transversal Clinical Nutrition Unit, University Hospital, Caen
  • Cherbourg, France, 50100
    • Transversal Nutrition Unit, Hospital, Cherbourg
  • Nantes, France, 44093
    • Nutrition Department, University Hospital, Nantes
  • Poitiers, France, 86000
    • Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers
  • Reims, France, 51092
    • Endocrinology, diabetology and nutrition department, University Hospital, Reims
  • Rennes, France, 35033
    • Endocrinology, diabetology and nutrition department, University Hospital, Rennes
  • Tours, France, 37044
    • Metabolic and nutritional exploration, University Hospital, Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Cognitive and Behavioral Therapy; 12 sessions of CBT using a standardized approach
No Intervention: Management as usual; management of obesity with nutritional and dietary treatment as usual

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Paul BRUNAULT, MD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): March 3, 2025
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; obesity; hypertension; metabolic syndrome; dyslipidemia; psychiatric disorders; binge eating disorder; food addiction; addictive disorders; obesity-specific quality of life; hepatic cytolysis; cognitive and behavioral therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Overweight; Lipid Metabolism Disorders; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Feeding and Eating Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Food Addiction; Obesity; Hypertension; Metabolic Syndrome; Mental Disorders; Diabetes Mellitus; Dyslipidemias; Binge-Eating Disorder; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: DR190068; 2019-A02773-54 (Other Identifier: IdRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No