Clinical trial NCT04338178: Efficacy of a Cognitive - Affective - Addictive Based Intervention to Decrease Food Craving in Obese Patients.
Official title: Efficacy of a Multi-component Treatment Program Integrating Cognitive - Affective - Addictive Based Intervention in Obese Patients: a Prospective Multicentric Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Craving
Cognitive Behavioral Therapy
Cognitive Remediation Therapy
Addiction
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2020-04-08
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Since the 80's, the prevalence of obesity has more than doubled and despite progression of knowledge, interventions usually lead to a transient reduction in body weight that is not maintained in the long-term. These failures in weight management may be partly explained by an incomplete understanding of obesity risk and maintaining factors.

Behavioral and neurobiological similarities between use of high palatable foods and addictive psychoactive drugs have led to the concept of food addiction. Addiction is defined as a loss of control of use, and its persistence despite accumulation of negative consequences. Craving, an uncontrollable and involuntary urge to use, has shown to be a core determinant of persistent use and relapse in addiction. Recent studies have established that food addiction, craving and emotional eating concern a large part of obese patients, and that food addiction may explain some negative outcomes of weight loss treatments, such as unsuccessful attempts to reduce calories and early termination of treatment programs.

Recent advances in neuropsychiatry suggest that an imbalanced interplay between cognitive and affective processes impedes self-control and enhances over- or under-controlled behaviors. In the field of food intake and weight management, there is increasing evidence that besides environmental factors, inefficient executive functions and emotion regulation skills are salient phenomena underlying habit-forming processes that are present in eating disorder subtypes as well as obesity. This has led some authors to consider disordered eating behaviors as 'allostatic' reactions by which the modulation of food intake is used by vulnerable individuals to adjust to craving, maladaptive cognitive and/or emotional strategies.

Current recommendations emphasize the need for translating these discoveries into treatments to promote healthy eating and weight management.

Over the last 5 years, a growing base of clinical and behavioural studies have indicated that, individually, Cognitive-Behavioural Therapy (CBT), Emotional Skills Training (EST), and Cognitive Remediation Therapy (CRT) are promising techniques to decrease disordered eating behaviors, including craving.

The investigators hypothesize that addition to treatment as usual (TAU) of a specific program targeting executive functions, emotional regulation, and addictive-like eating behaviors, could have a beneficial impact on reported food craving, and improve weight management among obese patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Treatment seeking obese patients (30 kg/m2 ≤ BMI ≤ 45 kg/m2)
* Report at least one food craving episode in the 30 days before pre-inclusion visit (assessed by one question adapted from the State version of the Food Cravings Questionnaire, FCQ-S)
* Able to participate in group sessions once a week for 10 weeks
* Affiliated person or beneficiary of a social security scheme

Exclusion Criteria:

* Severely impaired physical and/or mental health that, according to the investigator, may affect the participant's compliance with the study and understanding of assessment tools
* Difficulty in understanding and / or writing French
* Hypothalamic obesity
* Impossibility to be reached by telephone
* Individuals participating in another study that includes an ongoing exclusion period
* Be deprived of liberty due to an ongoing legal procedure
* Pregnancy or breastfeeding
* Individuals under legal protection or unable to express personally their consent

Primary outcomes:
measure: Change in Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score
timeFrame: Baseline (T0) and 12 weeks (T1)
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: 12 weeks (T1)
measure: Body mass index (BMI)
timeFrame: 6 months (T2)
measure: Waist circumference
timeFrame: 12 weeks (T1)
measure: Waist circumference
timeFrame: 6 months (T2)
measure: Percentage of body fat and fat-free mass
timeFrame: 12 weeks (T1)
measure: Percentage of body fat and fat-free mass
timeFrame: 6 months (T2)
measure: Emotional Appetite Questionnaire (EMAQ) Score
timeFrame: 12 weeks (T1)
measure: Emotional Appetite Questionnaire (EMAQ) Score
timeFrame: 6 months (T2)
measure: Eating Disorder Examination-Questionnaire (EDE-Q) Score
timeFrame: 12 weeks (T1)
measure: Eating Disorder Examination-Questionnaire (EDE-Q) Score
timeFrame: 6 months (T2)
measure: Dutch Eating Behaviour Questionnaire (DEBQ) Score
timeFrame: 12 weeks (T1)
measure: Dutch Eating Behaviour Questionnaire (DEBQ) Score
timeFrame: 6 months (T2)
measure: modified Yale Food Addiction Scale (mYFAS) Assessment
timeFrame: 12 weeks (T1)
measure: modified Yale Food Addiction Scale (mYFAS) Assessment
timeFrame: 6 months (T2)
measure: Psychiatric disorders assessment using the Mini International Neuropsychiatric Interview (MINI)
timeFrame: 6 months (T2)
measure: Interviewer Severity Rating (ISR) established for Addiction Severity Index (ASI)
timeFrame: 6 months (T2)
measure: Trail Making Test (TMT) completion time and number of perseverative errors
timeFrame: 12 weeks (T1)
measure: Wisconsin Card Sorting Test 64 (WCST) number and percentage of perseverative errors
timeFrame: 12 weeks (T1)
measure: Zoo test Score
timeFrame: 12 weeks (T1)
measure: UPPS Impulsive Behavior Scale Score
timeFrame: 12 weeks (T1)
measure: Monetary Choice Questionnaire (MCQ)
timeFrame: 12 weeks (T1)
measure: Performances (flexibility) at the Stroop and Verbal Fluency computerized tests (EMA).
timeFrame: 12 weeks (T1)
measure: Difficulties in Emotion Regulation Scale (DERS) Score
timeFrame: 12 weeks (T1)
measure: Difficulties in Emotion Regulation Scale (DERS) Score
timeFrame: 6 months (T2)
measure: Depression Anxiety Stress Scales (DASS-21) Score
timeFrame: 12 weeks (T1)
measure: Depression Anxiety Stress Scales (DASS-21) Score
timeFrame: 6 months (T2)
measure: Quality Of Life, Obesity and Dietetics rating scale (QOLOD) Score
timeFrame: 12 weeks (T1)
measure: Quality Of Life, Obesity and Dietetics rating scale (QOLOD) Score
timeFrame: 6 months (T2)
measure: Number of sessions completed (Compliance)
timeFrame: After the 10th session (S10)
measure: Patient Satisfaction Questionnaire (PSQ) Score
timeFrame: After the 3rd session (Week 3)
measure: Patient Satisfaction Questionnaire (PSQ) Score
timeFrame: After the 6th session (Week 6)
measure: Patient Satisfaction Questionnaire (PSQ) Score
timeFrame: After the 9th session (Week 9)
measure: Motivation to change Score
timeFrame: 12 weeks (T1)
measure: Revised Helping Alliance Questionnaire (HAQ-11) Score
timeFrame: 12 weeks (T1)
measure: Ecological Momentary Assessment data collection
timeFrame: During 7 days after baseline
measure: Ecological Momentary Assessment data collection
timeFrame: During 7 days after the 10th session (Week 10 to week 11)
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique Hôpitaux de Paris Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Assistance Publique Hôpitaux de Paris Hôpital Ambroise Paré
city: Pessac
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Mélina FATSEAS
role: PRINCIPAL_INVESTIGATOR
affiliation: CNRS UMR 5287 - INCIA
name: Sylvie BERTHOZ
role: STUDY_DIRECTOR
References: