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

Last updated: November 28, 2023
Sponsor: University Hospital, Tours
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Addictions

Bulimia

Treatment

Cognitive and Behavioral Therapy

Clinical Study ID

NCT04626570
DR190068
2019-A02773-54
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Difficulties in understanding the self-administered questionnaires, includingilliteracy
  • Impossibility to participate to the CBT sessions (i.e., no phone, scheduledunavailability)
  • 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 usedisorder)
  • Current medication with a significant adverse effect on eating behavior (i.e.,lithium, neuroleptic/antipsychotic)
  • Discrepancy between self-administered questionnaires and the clinical interviewconducted prior to inclusion (for the assessment of food addiction diagnosis).
  • Condition associated with important weight variations (i.e., oedema related to severecardiac insufficiency, renal insufficiency, hepatic insufficiency with cirrhosis,exudative enteropathy)
  • Participation to another psychological or pharmacological interventional study thatcould impact our primary or secondary outcomes
  • Wearing a pace-maker or metal prosthesis
  • Person under tutorship or curatorship

Study Design

Total Participants: 154
Treatment Group(s): 1
Primary Treatment: Cognitive and Behavioral Therapy
Phase:
Study Start date:
January 20, 2021
Estimated Completion Date:
January 31, 2025

Study 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).

Connect with a study center

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

    Angers, 49933
    France

    Active - Recruiting

  • Nutrition Department, University Hospital, Brest

    Brest, 29609
    France

    Active - Recruiting

  • Transversal Clinical Nutrition Unit, University Hospital, Caen

    Caen, 14033
    France

    Active - Recruiting

  • Transversal Nutrition Unit, Hospital, Cherbourg

    Cherbourg, 50100
    France

    Active - Recruiting

  • Nutrition Department, University Hospital, Nantes

    Nantes, 44093
    France

    Active - Recruiting

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

    Poitiers, 86000
    France

    Active - Recruiting

  • Endocrinology, diabetology and nutrition department, University Hospital, Reims

    Reims, 51092
    France

    Active - Recruiting

  • Endocrinology, diabetology and nutrition department, University Hospital, Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • Metabolic and nutritional exploration, University Hospital, Tours

    Tours, 37044
    France

    Active - Recruiting

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