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Completed

NCT Number: NCT04626570

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

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).

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive and Behavioral Therapy

Other

12 sessions of CBT using a standardized approach

Primary outcomes

  1. Percentage of patients without food addiction

    Time frame: 18 weeks after randomization

    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 outcomes

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

    Time frame: From baseline, up to 9 months

    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)

  2. Evolution of number of criteria for food addiction

    Time frame: From baseline, up to 9 months

    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)

  3. Weight/BMI evolution

    Time frame: From baseline, up to 9 months

    Weight and height measurement

  4. Evolution of the waist-to-hip ratio

    Time frame: From baseline, up to 9 months

    Waist and hip measurement

  5. Evolution of Body Composition

    Time frame: From baseline, up to 9 months

    Impedancemetry

  6. Existence and evolution psychiatric and addictive disorders

    Time frame: From baseline, up to 18 weeks

    Mini International Neuropsychiatric Interview 5.0.0 (MINI 5.0.0)

  7. Existence and evolution of depression

    Time frame: From baseline, up to 9 months

    Beck Depression Inventory (BDI)

  8. Existence and evolution of bulimic hyperphagia

    Time frame: From baseline, up to 9 months

    Binge Eating Scale (BES)

  9. Existence and evolution of an alcohol use disorder

    Time frame: From baseline, up to 9 months

    Alcohol Use Disorder Inventory Test (AUDIT)

  10. Existence and evolution of a Smoking Disorder

    Time frame: From baseline, up to 9 months

    Fagerström Test for Nicotine Dependence (FTND)

  11. Existence and evolution of food cravings

    Time frame: From baseline, up to 9 months

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

  12. Existence and evolution of emotional eating

    Time frame: From baseline, up to 9 months

    Dutch Eating Behavior Questionnaire (DEBQ)

  13. Evolution of quality of life

    Time frame: From baseline, up to 9 months

    Quality of Life, Obesity and Dietetics (QOLOD)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: ADALOB

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2020
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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