ObesityADALOBNCT04626570
Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity
A study testing Cognitive and Behavioral Therapy in people with Obesity and Food Addiction, run by University Hospital, Tours at 9 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Food Addiction
- What is being tested?
- Cognitive and Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 9 sitesFrance
- Study dates
- 20 Jan 2021to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Department of endocrinology-diabetology-nutrition, University Hospital, Angers
Angers, 49933
Nutrition Department, University Hospital, Brest
Brest, 29609
Transversal Clinical Nutrition Unit, University Hospital, Caen
Caen, 14033
Transversal Nutrition Unit, Hospital, Cherbourg
Cherbourg, 50100
Nutrition Department, University Hospital, Nantes
Nantes, 44093
Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers
Poitiers, 86000
Endocrinology, diabetology and nutrition department, University Hospital, Reims
Reims, 51092
Endocrinology, diabetology and nutrition department, University Hospital, Rennes
Rennes, 35033
Metabolic and nutritional exploration, University Hospital, Tours
Tours, 37044
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.
Read more
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).
Read the detailed 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).
- Conditions
- Obesity, Food Addiction
- Being tested
- Cognitive and Behavioral Therapy
- 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
- Medical subject headings
- Obesity, Food Addiction, Binge-Eating Disorder, Mental Disorders, Metabolic Syndrome, Diabetes Mellitus, Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and Behavioral TherapyOther
12 sessions of CBT using a standardized approach
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Cognitive and Behavioral Therapy |
| Management as usual | No intervention | management of obesity with nutritional and dietary treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 weeks after randomization
Secondary outcomes (13)
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)
Measured: From baseline, up to 9 months
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)
Measured: From baseline, up to 9 months
Weight/BMI evolution
Weight and height measurement
Measured: From baseline, up to 9 months
Evolution of the waist-to-hip ratio
Waist and hip measurement
Measured: From baseline, up to 9 months
Evolution of Body Composition
Impedancemetry
Measured: From baseline, up to 9 months
Existence and evolution psychiatric and addictive disorders
Mini International Neuropsychiatric Interview 5.0.0 (MINI 5.0.0)
Measured: From baseline, up to 18 weeks
Existence and evolution of depression
Beck Depression Inventory (BDI)
Measured: From baseline, up to 9 months
Existence and evolution of bulimic hyperphagia
Binge Eating Scale (BES)
Measured: From baseline, up to 9 months
Existence and evolution of an alcohol use disorder
Alcohol Use Disorder Inventory Test (AUDIT)
Measured: From baseline, up to 9 months
Existence and evolution of a Smoking Disorder
Fagerström Test for Nicotine Dependence (FTND)
Measured: From baseline, up to 9 months
Existence and evolution of food cravings
Food Cravings Questionnaire-Trait-reduced (FCQ-T-r)
Measured: From baseline, up to 9 months
Existence and evolution of emotional eating
Dutch Eating Behavior Questionnaire (DEBQ)
Measured: From baseline, up to 9 months
Evolution of quality of life
Quality of Life, Obesity and Dietetics (QOLOD)
Measured: From baseline, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start20 Jan 2021
- Primary completion3 Mar 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul BRUNAULT, MD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626570
- Sponsor's protocol ID
- DR190068
- Other IDs
- 2019-A02773-54
- Acronym
- ADALOB
- Status last verified
- Nov 2025
- First submitted
- 10 Nov 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity
- ClinicalTrials.gov ID
- NCT04626570
- Acronym / sponsor ID
- ADALOB / DR190068
- Conditions
- Obesity, Food Addiction
- Keywords
- obesity, food addiction, binge eating disorder, psychiatric disorders, addictive disorders, obesity-specific quality of life, metabolic syndrome, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive and Behavioural Therapy plus Management as usual | Experimental | Other: Cognitive and Behavioral Therapy12 sessions of CBT during 18 weeks AND management of obesity with nutritional and dietary treatment as usual |
| Management as usual | No intervention | –management of obesity with nutritional and dietary treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive and Behavioral Therapy12 sessions of CBT using a standardized approach | Other | Cognitive and Behavioural Therapy plus Management as usual |
Primary outcome
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)
13 secondary outcomes
Evolution of Percentage of patients without food addiction during follow-up
Time frame: From baseline, up to 9 months
Evolution of number of criteria for food addiction
Time frame: From baseline, up to 9 months
Weight/BMI evolution
Time frame: From baseline, up to 9 months
Evolution of the waist-to-hip ratio
Time frame: From baseline, up to 9 months
Evolution of Body Composition
Time frame: From baseline, up to 9 months
Existence and evolution psychiatric and addictive disorders
Time frame: From baseline, up to 18 weeks
Existence and evolution of depression
Time frame: From baseline, up to 9 months
Existence and evolution of bulimic hyperphagia
Time frame: From baseline, up to 9 months
Existence and evolution of an alcohol use disorder
Time frame: From baseline, up to 9 months
Existence and evolution of a Smoking Disorder
Time frame: From baseline, up to 9 months
Existence and evolution of food cravings
Time frame: From baseline, up to 9 months
Existence and evolution of emotional eating
Time frame: From baseline, up to 9 months
Evolution of quality of life
Time frame: From baseline, up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul BRUNAULT, MD study director
University Hospital, Tours
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and Behavioral Therapy in people with Obesity and Food Addiction, run by University Hospital, Tours at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients without food addiction (time frame: 18 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.