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

NCT04626570 | Completed

• 2 other identifiers: DR1900682019-A02773-54
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 9

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Evolution of Percentage of patients without food addiction during follow-up

  From baseline, up to 9 months

• Evolution of number of criteria for food addiction

  From baseline, up to 9 months

• Weight/BMI evolution

  From baseline, up to 9 months

• Evolution of the waist-to-hip ratio

  From baseline, up to 9 months

• Evolution of Body Composition

  From baseline, up to 9 months

Study Arms (2)

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

Other: Cognitive and Behavioral Therapy

Management as usual

NO INTERVENTION

management of obesity with nutritional and dietary treatment as usual

Interventions

Cognitive and Behavioral Therapy OTHER

12 sessions of CBT using a standardized approach

Cognitive and Behavioural Therapy plus Management as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (9)

Department of endocrinology-diabetology-nutrition, University Hospital, Angers

Angers, 49933, France

Location

Nutrition Department, University Hospital, Brest

Brest, 29609, France

Location

Transversal Clinical Nutrition Unit, University Hospital, Caen

Caen, 14033, France

Location

Transversal Nutrition Unit, Hospital, Cherbourg

Cherbourg, 50100, France

Location

Nutrition Department, University Hospital, Nantes

Nantes, 44093, France

Location

Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers

Poitiers, 86000, France

Location

Endocrinology, diabetology and nutrition department, University Hospital, Reims

Reims, 51092, France

Location

Endocrinology, diabetology and nutrition department, University Hospital, Rennes

Rennes, 35033, France

Location

Metabolic and nutritional exploration, University Hospital, Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Obesity; Food Addiction; Binge-Eating Disorder; Mental Disorders; Metabolic Syndrome; Diabetes Mellitus; Dyslipidemias; Hypertension

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding and Eating Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Paul BRUNAULT, MD

  University Hospital, Tours

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 12, 2020
• Study Start: January 20, 2021
• Primary Completion: March 3, 2025
• Study Completion: July 25, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

FR (9)