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

Obesity Clinical Trial

— ADALOB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626570
• Other study ID #: DR190068
• Secondary ID: 2019-A02773-54
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Tours
• Contact: Paul BRUNAULT, MD
• Phone: 0218370581
• Email: paul.brunault[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: January 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Food Addiction
• Obesity
• Obesity, Morbid

Intervention

Other:
• Cognitive and Behavioral Therapy
12 sessions of CBT using a standardized approach

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Weight/BMI evolution	Weight and height measurement	From baseline, up to 9 months
Secondary	Evolution of the waist-to-hip ratio	Waist and hip measurement	From baseline, up to 9 months
Secondary	Evolution of Body Composition	Impedancemetry	From baseline, up to 9 months
Secondary	Existence and evolution psychiatric and addictive disorders	Mini International Neuropsychiatric Interview 5.0.0 (MINI 5.0.0)	From baseline, up to 18 weeks
Secondary	Existence and evolution of depression	Beck Depression Inventory (BDI)	From baseline, up to 9 months
Secondary	Existence and evolution of bulimic hyperphagia	Binge Eating Scale (BES)	From baseline, up to 9 months
Secondary	Existence and evolution of an alcohol use disorder	Alcohol Use Disorder Inventory Test (AUDIT)	From baseline, up to 9 months
Secondary	Existence and evolution of a Smoking Disorder	Fagerström Test for Nicotine Dependence (FTND)	From baseline, up to 9 months
Secondary	Existence and evolution of food cravings	Food Cravings Questionnaire-Trait-reduced (FCQ-T-r)	From baseline, up to 9 months
Secondary	Existence and evolution of emotional eating	Dutch Eating Behavior Questionnaire (DEBQ)	From baseline, up to 9 months
Secondary	Evolution of quality of life	Quality of Life, Obesity and Dietetics (QOLOD)	From baseline, up to 9 months