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

Primary Purpose

Obesity, Food Addiction

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Cognitive and Behavioral Therapy

About this trial

This is an interventional treatment trial for Obesity focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of endocrinology-diabetology-nutrition, University Hospital, AngersRecruiting
Nutrition Department, University Hospital, Brest
Transversal Clinical Nutrition Unit, University Hospital, Caen
Transversal Nutrition Unit, Hospital, Cherbourg
Nutrition Department, University Hospital, NantesRecruiting
Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, PoitiersRecruiting
Endocrinology, diabetology and nutrition department, University Hospital, ReimsRecruiting
Endocrinology, diabetology and nutrition department, University Hospital, RennesRecruiting
Metabolic and nutritional exploration, University Hospital, ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive and Behavioural Therapy plus Management as usual

Management as usual

Arm Description

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

management of obesity with nutritional and dietary treatment as usual

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

Weight/BMI evolution

Weight and height measurement

Evolution of the waist-to-hip ratio

Waist and hip measurement

Evolution of Body Composition

Impedancemetry

Existence and evolution psychiatric and addictive disorders

Mini International Neuropsychiatric Interview 5.0.0 (MINI 5.0.0)

Existence and evolution of depression

Beck Depression Inventory (BDI)

Existence and evolution of bulimic hyperphagia

Binge Eating Scale (BES)

Existence and evolution of an alcohol use disorder

Alcohol Use Disorder Inventory Test (AUDIT)

Existence and evolution of a Smoking Disorder

Fagerström Test for Nicotine Dependence (FTND)

Existence and evolution of food cravings

Food Cravings Questionnaire-Trait-reduced (FCQ-T-r)

Existence and evolution of emotional eating

Dutch Eating Behavior Questionnaire (DEBQ)

Evolution of quality of life

Quality of Life, Obesity and Dietetics (QOLOD)

Full Information

NCT ID

NCT04626570

First Posted

November 10, 2020

Last Updated

June 2, 2022

Sponsor

University Hospital, Tours

1. Study Identification

Unique Protocol Identification Number

NCT04626570

Brief Title

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

Acronym

ADALOB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2021 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitive and Behavioural Therapy plus Management as usual

Arm Type

Experimental

Arm Description

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

Arm Title

Management as usual

Arm Type

No Intervention

Arm Description

management of obesity with nutritional and dietary treatment as usual

Intervention Type

Other

Intervention Name(s)

Cognitive and Behavioral Therapy

Intervention Description

12 sessions of CBT using a standardized approach

Primary Outcome Measure Information:

Title

Percentage of patients without food addiction

Description

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)

Time Frame

18 weeks after randomization

Secondary Outcome Measure Information:

Title

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

Description

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)

Time Frame

From baseline, up to 9 months

Title

Evolution of number of criteria for food addiction

Description

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)

Time Frame

From baseline, up to 9 months

Title

Weight/BMI evolution

Description

Weight and height measurement

Time Frame

From baseline, up to 9 months

Title

Evolution of the waist-to-hip ratio

Description

Waist and hip measurement

Time Frame

From baseline, up to 9 months

Title

Evolution of Body Composition

Description

Impedancemetry

Time Frame

From baseline, up to 9 months

Title

Existence and evolution psychiatric and addictive disorders

Description

Mini International Neuropsychiatric Interview 5.0.0 (MINI 5.0.0)

Time Frame

From baseline, up to 18 weeks

Title

Existence and evolution of depression

Description

Beck Depression Inventory (BDI)

Time Frame

From baseline, up to 9 months

Title

Existence and evolution of bulimic hyperphagia

Description

Binge Eating Scale (BES)

Time Frame

From baseline, up to 9 months

Title

Existence and evolution of an alcohol use disorder

Description

Alcohol Use Disorder Inventory Test (AUDIT)

Time Frame

From baseline, up to 9 months

Title

Existence and evolution of a Smoking Disorder

Description

Fagerström Test for Nicotine Dependence (FTND)

Time Frame

From baseline, up to 9 months

Title

Existence and evolution of food cravings

Description

Food Cravings Questionnaire-Trait-reduced (FCQ-T-r)

Time Frame

From baseline, up to 9 months

Title

Existence and evolution of emotional eating

Description

Dutch Eating Behavior Questionnaire (DEBQ)

Time Frame

From baseline, up to 9 months

Title

Evolution of quality of life

Description

Quality of Life, Obesity and Dietetics (QOLOD)

Time Frame

From baseline, up to 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul BRUNAULT, MD

Phone

0218370581

Ext

+33

paul.brunault@univ-tours.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul BRUNAULT, MD

Organizational Affiliation

University Hospital, Tours

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Angers

ZIP/Postal Code

49933

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agnès SALLE, MD

First Name & Middle Initial & Last Name & Degree

Bénédicte GOHIER, MD-PhD

First Name & Middle Initial & Last Name & Degree

Agnès Salle, MD

Facility Name

Nutrition Department, University Hospital, Brest

City

Brest

ZIP/Postal Code

29609

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacques DELARUE, MD-PhD

First Name & Middle Initial & Last Name & Degree

Véronique GRINER-ABRAHAM, MD

First Name & Middle Initial & Last Name & Degree

Jacques DELARUE, MD

Facility Name

Transversal Clinical Nutrition Unit, University Hospital, Caen

City

Caen

ZIP/Postal Code

14033

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Véronique SAVEY, MD

First Name & Middle Initial & Last Name & Degree

Nicolas CABE, MD

First Name & Middle Initial & Last Name & Degree

Véronique SAVEY, MD

Facility Name

Transversal Nutrition Unit, Hospital, Cherbourg

City

Cherbourg

ZIP/Postal Code

50100

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cindy BECHE, MD

First Name & Middle Initial & Last Name & Degree

Anne DUTEIL

First Name & Middle Initial & Last Name & Degree

Cindy BECHE, MD

Facility Name

Nutrition Department, University Hospital, Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David JACOBI, MD-PhD

First Name & Middle Initial & Last Name & Degree

Marie GRALL-BRONNEC, MD-PhD

First Name & Middle Initial & Last Name & Degree

David JACOBI, MD-PhD

Facility Name

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

City

Poitiers

ZIP/Postal Code

86000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xavier PIGUEL, MD

First Name & Middle Initial & Last Name & Degree

Diane LEVY-CHAVAGNAT, MD

First Name & Middle Initial & Last Name & Degree

Xavier PIGUEL, MD

Facility Name

Endocrinology, diabetology and nutrition department, University Hospital, Reims

City

Reims

ZIP/Postal Code

51092

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric BERTIN, MD-PhD

First Name & Middle Initial & Last Name & Degree

Farid BENZEROUK, MD

First Name & Middle Initial & Last Name & Degree

Eric BERTIN, MD-PhD

Facility Name

Endocrinology, diabetology and nutrition department, University Hospital, Rennes

City

Rennes

ZIP/Postal Code

35033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronan THIBAULT, MD-PhD

First Name & Middle Initial & Last Name & Degree

Romain MOIRAND, MD-PhD

First Name & Middle Initial & Last Name & Degree

Ronan THIBAULT, MD-PhD

Facility Name

Metabolic and nutritional exploration, University Hospital, Tours

City

Tours

ZIP/Postal Code

37044

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnaud DE LUCA, MD

First Name & Middle Initial & Last Name & Degree

Paul BRUNAULT, MD

First Name & Middle Initial & Last Name & Degree

Arnaud DE LUCA, MD

12. IPD Sharing Statement

Learn more about this trial

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

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