ObesityOBESADEMNCT04338178
Efficacy of a Cognitive - Affective - Addictive Based Intervention to Decrease Food Craving in Obese Patients.
A study testing Cognitive Remediation Therapy (CRT), Emotional Skills Training (EST) and Cognitive Behavioral Therapy in people with Obesity and Craving, run by University Hospital, Bordeaux at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Craving, Cognitive Behavioral Therapy
- What is being tested?
- Cognitive Remediation Therapy (CRT), Emotional Skills Training (EST) and Cognitive Behavioral Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Nov 2021to 19 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Assistance Publique Hôpitaux de Paris Hôpital Européen Georges Pompidou
Paris, 75 015
Assistance Publique Hôpitaux de Paris Hôpital Ambroise Paré
Paris, 92 100
CHU de Bordeaux
Pessac, 33600
About this study
Official title: Efficacy of a Multi-component Treatment Program Integrating Cognitive - Affective - Addictive Based Intervention in Obese Patients: a Prospective Multicentric Randomized Clinical Trial
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.
Read more
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.
- Being tested
- Cognitive Remediation Therapy (CRT), Emotional Skills Training (EST), Cognitive Behavioral Therapy, Multidisciplinary outpatient program
- Medical subject headings
- Obesity, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation Therapy (CRT)Behavioural
This intervention consists of mental exercises aimed at improving executive function via practice. Simple cognitive tasks that encourage reflective learning and insight into patient's own thinking process are administered. Exercises target set-shifting (i.e., cognitive flexibility), estimating, organization and planning.
Emotional Skills Training (EST)Behavioural
EST places emphasis on the improvement of inner emotion awareness, facial and body expression recognition and intra- and interpersonal emotion regulation skills. Different modules and interactive exercises are designed to help patients learn about i) the functions and manifestations of emotions, ii) the identification and labelling of own's and others' emotions, iii) tolerating and communicating emotions, and iiii) balancing between negative and positive emotions.
Cognitive Behavioral TherapyBehavioural
CBT intervention aimed to manage food craving by teaching group members cognitive (e.g., restructuring of urge-related thoughts) and behavioural strategies (e.g., increasing awareness through food diaries, relaxation skills, identification of cues that trigger craving, avoidance of high-risk situations for craving, distraction).
Multidisciplinary outpatient programProcedure or surgery
Multidisciplinary outpatient program including several consultations with endocrinologists, dietitians, psychologists, nutritionists and/or physical activity coaches. Patients are regularly followed and educated about the importance of lifestyle changes including healthy dietary habits and exercise in weight reduction and maintenance. Patients are also usually given information about nutritional value of various foods and few simple exercises for decreasing and maintaining body weight. This program is therefore planned as part of the usual care and responds to the recommendations of good practice for obesity
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention | Experimental | Standard outpatient program, with additional group sessions integrating the experimental intervention : Cognitive Remediation Therapy (CRT), Emotional Skills Training (EST), and Cognitive Behavioral Therapy focused on craving and food addiction (CBT), delivered once a week during 10 weeks. Receives: Behavioral: Cognitive Remediation Therapy (CRT); Behavioral: Emotional Skills Training (EST); Behavioral: Cognitive Behavioral Therapy |
| Standard intervention | Active comparator | Standard outpatient program, with additional group sessions integrating control intervention : multidisciplinary outpatient program including several consultations with endocrinologists, dietitians, psychologists, nutritionists and/or physical activity coaches, delivered once a week during 10 weeks. Receives: Procedure: Multidisciplinary outpatient program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score
Self-administered questionnaire consisting of 15 items assessing several aspects of food craving: lack of control over eating, thoughts or preoccupation with food, intentions and plans to consume food, emotions before or during food craving, cues that may trigger food craving
Measured: Baseline (T0) and 12 weeks (T1)
Secondary outcomes (36)
Body mass index (BMI)
Body mass index (BMI) is a measure of body fat based on height and weight, expressed in kg/m2
Measured: 12 weeks (T1)
Body mass index (BMI)
Body mass index (BMI) is a measure of body fat based on height and weight, expressed in kg/m2
Measured: 6 months (T2)
Waist circumference
Waist circumference measured following the WHO STEPwise approach to surveillance (STEPS) and their corresponding guidelines for physical measurement
Measured: 12 weeks (T1)
Waist circumference
Waist circumference measured following the WHO STEPwise approach to surveillance (STEPS) and their corresponding guidelines for physical measurement
Measured: 6 months (T2)
Percentage of body fat and fat-free mass
Bio Impedance Analysis (BIA) is a more specific measure of body composition and adiposity. The variables of interest will be the percentages of body fat and fat-free mass.
Measured: 12 weeks (T1)
Percentage of body fat and fat-free mass
Bio Impedance Analysis (BIA) is a more specific measure of body composition and adiposity. The variables of interest will be the percentages of body fat and fat-free mass.
Measured: 6 months (T2)
Emotional Appetite Questionnaire (EMAQ) Score
Emotional Appetite Questionnaire (EMAQ) contains 22 items assessing variations of food intake in response to emotional states and situations. 9 items evaluate negative emotions, 5 evaluate positive emotions, 5 refer to negative situations and 3 to positive situations.A score is calculated for positive emotions (EMAQ-PE), negative emotions (EMAQ-NE), positive situations (EMAQ-PS) and negative situations (EMAQ-NS). For each subscale, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscales. A positive total score (EMAQ-P) is obtained by averaging the EMAQ-PE and EMAQ-PS scores. A negative total score (EMAQ-N) is obtained by averaging the EMAQ-NE and EMAQ.
Measured: 12 weeks (T1)
Emotional Appetite Questionnaire (EMAQ) Score
Emotional Appetite Questionnaire (EMAQ) contains 22 items assessing variations of food intake in response to emotional states and situations. 9 items evaluate negative emotions, 5 evaluate positive emotions, 5 refer to negative situations and 3 to positive situations.A score is calculated for positive emotions (EMAQ-PE), negative emotions (EMAQ-NE), positive situations (EMAQ-PS) and negative situations (EMAQ-NS). For each subscale, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscales. A positive total score (EMAQ-P) is obtained by averaging the EMAQ-PE and EMAQ-PS scores. A negative total score (EMAQ-N) is obtained by averaging the EMAQ-NE and EMAQ.
Measured: 6 months (T2)
Eating Disorder Examination-Questionnaire (EDE-Q) Score
Eating Disorder Examination-Questionnaire (EDE-Q) includes 36-item assessing the frequency of disordered eating behaviors over the past 28 days. The EDE-Q provides subscale scores reflecting the severity of aspects of the psychopathology of eating disorders. The subscales are Restraint, Eating Concern, Shape Concern and Weight Concern. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscales. If ratings are only available on some items, a score may nevertheless be obtained by dividing the resulting total by the number of rated items as long as more than half the items have been rated. To obtain total score, the four subscales scores are summed and the resulting total divided by the number of subscales (i.e. four). The variables of interest will be the EDE-Q total score and subscales' scores.
Measured: 12 weeks (T1)
Eating Disorder Examination-Questionnaire (EDE-Q) Score
Eating Disorder Examination-Questionnaire (EDE-Q) includes 36-item assessing the frequency of disordered eating behaviors over the past 28 days. The EDE-Q provides subscale scores reflecting the severity of aspects of the psychopathology of eating disorders. The subscales are Restraint, Eating Concern, Shape Concern and Weight Concern. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscales. If ratings are only available on some items, a score may nevertheless be obtained by dividing the resulting total by the number of rated items as long as more than half the items have been rated. To obtain total score, the four subscales scores are summed and the resulting total divided by the number of subscales (i.e. four). The variables of interest will be the EDE-Q total score and subscales' scores.
Measured: 6 months (T2)
Dutch Eating Behaviour Questionnaire (DEBQ) Score
Dutch Eating Behaviour Questionnaire (DEBQ) consists of 33 items and assesses on a 5-point Likert scale, ranging from "never" to "very often" external, restraint and emotional eating. For the study, only the 10 items of the external eating subscale will be used. The variable of interest will be the corresponding External eating subscale score.
Measured: 12 weeks (T1)
Dutch Eating Behaviour Questionnaire (DEBQ) Score
Dutch Eating Behaviour Questionnaire (DEBQ) consists of 33 items and assesses on a 5-point Likert scale, ranging from "never" to "very often" external, restraint and emotional eating. For the study, only the 10 items of the external eating subscale will be used. The variable of interest will be the corresponding External eating subscale score.
Measured: 6 months (T2)
modified Yale Food Addiction Scale (mYFAS) Assessment
modified Yale Food Addiction Scale (mYFAS) 2.0 : is a 35-item self-report scale assessing Food Addiction (FA) symptoms based on the 11 diagnostic criteria for substance related and addictive disorders proposed in the DSM-5. FA is mild if there are 2 or 3 symptoms and clinically significant impairment/distress, moderate if there are 4 or 5 symptoms and significant impairment/distress, and severe if there are 6 or more symptoms and significant impairment/distress. The variables of interest will be the number of symptoms and the presence (vs absence) of a FA diagnosis.
Measured: 12 weeks (T1)
modified Yale Food Addiction Scale (mYFAS) Assessment
modified Yale Food Addiction Scale (mYFAS) 2.0 : is a 35-item self-report scale assessing Food Addiction (FA) symptoms based on the 11 diagnostic criteria for substance related and addictive disorders proposed in the DSM-5. FA is mild if there are 2 or 3 symptoms and clinically significant impairment/distress, moderate if there are 4 or 5 symptoms and significant impairment/distress, and severe if there are 6 or more symptoms and significant impairment/distress. The variables of interest will be the number of symptoms and the presence (vs absence) of a FA diagnosis.
Measured: 6 months (T2)
Psychiatric disorders assessment using the Mini International Neuropsychiatric Interview (MINI)
Mini International Neuropsychiatric Interview (MINI) is a structured diagnostic interview providing standardized assessment of psychiatric disorders defined according to Axis I DSM-5 : eating disorders, addictive disorders, mood disorders, anxiety disorders, and attention deficit hyperactivity disorder The variables of interest will be the proportion of patients with each of types of disorders. The number of comorbid psychiatric conditions will also be assessed using four categories : no comorbid disorder, one comorbid disorder, two comorbid disorders, three or more comorbid disorders
Measured: 6 months (T2)
Interviewer Severity Rating (ISR) established for Addiction Severity Index (ASI)
Addiction Severity Index (ASI) : is a semi-structured interview to assess impairments that commonly occur due to substance-related disorders . It explores seven areas that may be affected by addiction: medical status, employment/support status, substance and behavioral addiction, family and social relationships, legal status, and psychological status. For each area explored, an Interviewer Severity Rating (ISR) is established, from 0 to 9, reflecting the severity in the considered area. A score equal or above 4 reflects a need for additional treatment. ASI ISRs will be dichotomized to less than 4 or 4 and more (important need for additional treatment). The variables of interest will be the proportion of patients with need for additional treatment in each of the seven areas
Measured: 6 months (T2)
Trail Making Test (TMT) completion time and number of perseverative errors
Trail Making Test (TMT) : is used to measure cognitive and motor speed and mental flexibility. The variables of interest will the difference in completion time between TMT B and TMT A (TMT B - TMT A) and the number of perseverative errors on the TMT B.
Measured: 12 weeks (T1)
Wisconsin Card Sorting Test 64 (WCST) number and percentage of perseverative errors
Wisconsin Card Sorting Test 64 (WCST) : measures categorisation, inference, testing of hypotheses, cognitive flexibility, cognitive inhibition and response to feedback. The variable of interest will be the number and percentage of perseverative errors
Measured: 12 weeks (T1)
Zoo test Score
Zoo test : Is a subtest of the Behavioural Assessment of the Dysexecutive Syndrome (BADS). It provides information about subjects' ability to plan a route to visit six of a possible 12 locations in a zoo, firstly in a demanding, open-ended situation where little external structure is provided, and secondly in a situation that involves simply following a concrete, externally imposed strategy. The map and rules have been constructed so that there are only four variations on a route through the zoo that can be followed in order that none of the rules of the test are infringed. There are two trials. A profile score is computed based on planning time, execution time and the number of errors for both trials. The maximum profile score is of 4. The variable of interest will be the total profile score
Measured: 12 weeks (T1)
UPPS Impulsive Behavior Scale Score
The UPPS Impulsive Behavior Scale evaluates in 20 items five different impulsivity facets (4 items each) : Negative Urgency, Positive Urgency, Lack of Premeditation, Lack of Perseverance and Sensation Seeking. Each item are rated on Likert scale ranging from 1 ("I agree strongly") to 4 (" I disagree strongly"). For each subscale, a mean score of the available items is calculated. The variables of interest will be the five different impulsivity facets scores
Measured: 12 weeks (T1)
Monetary Choice Questionnaire (MCQ)
Monetary Choice Questionnaire (MCQ) includes a fixed set of 27 items with immediate rewards ranging from $11-$78 and delayed rewards ranging from $25-$85 with a delay of 7-186 days. Delayed rewards are grouped into three categories based on size, with nine items per category. Participants' hyperbolic discount parameter (k value) is determined by fitting data a discount function equation. The variables of interest will be the k value and the proportion of participants by k rank
Measured: 12 weeks (T1)
Performances (flexibility) at the Stroop and Verbal Fluency computerized tests (EMA).
Total number of correct words serves as the primary performance score
Measured: 12 weeks (T1)
Difficulties in Emotion Regulation Scale (DERS) Score
Difficulties in Emotion Regulation Scale (DERS) is a 36-item measure that assesses individuals' typical levels of difficulties in emotion regulation with six subscale: (a) nonacceptance of emotional responses, (b) difficulty engaging in goal-directed behavior when distressed, (c) impulse control difficulties when distressed, (d) lack of awareness of emotions, (e) limited access to strategies for regulation, and (f) lack of emotional clarity. For each subscale, a score is calculated by summing responses from relevant items. A total score is obtained by adding each subscale score. The variable of interest will be the DERS total score
Measured: 12 weeks (T1)
Difficulties in Emotion Regulation Scale (DERS) Score
Difficulties in Emotion Regulation Scale (DERS) is a 36-item measure that assesses individuals' typical levels of difficulties in emotion regulation with six subscale: (a) nonacceptance of emotional responses, (b) difficulty engaging in goal-directed behavior when distressed, (c) impulse control difficulties when distressed, (d) lack of awareness of emotions, (e) limited access to strategies for regulation, and (f) lack of emotional clarity. For each subscale, a score is calculated by summing responses from relevant items. A total score is obtained by adding each subscale score. The variable of interest will be the DERS total score
Measured: 6 months (T2)
Depression Anxiety Stress Scales (DASS-21) Score
Depression Anxiety Stress Scales (DASS-21) : is a 21-item measure of negative emotional symptoms that evaluates three dimensions: depression, anxiety and stress (7 items per subscale). A 4-point severity scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), measures the extent to which each emotional state has been experienced over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. Scores obtained will need to be multiplied by 2 to calculate the final score of each dimension. The variables of interest will be the three dimensions' scores.
Measured: 12 weeks (T1)
Depression Anxiety Stress Scales (DASS-21) Score
Depression Anxiety Stress Scales (DASS-21) : is a 21-item measure of negative emotional symptoms that evaluates three dimensions: depression, anxiety and stress (7 items per subscale). A 4-point severity scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), measures the extent to which each emotional state has been experienced over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. Scores obtained will need to be multiplied by 2 to calculate the final score of each dimension. The variables of interest will be the three dimensions' scores.
Measured: 6 months (T2)
Quality Of Life, Obesity and Dietetics rating scale (QOLOD) Score
Quality Of Life, Obesity and Dietetics rating scale (QOLOD) includes 36 items designed to assess quality of life in 5 domains: physical impact, psycho-social impact, impact on sex life , comfort with food, and diet experience The variables of interest will be the 5 subscales scores
Measured: 12 weeks (T1)
Quality Of Life, Obesity and Dietetics rating scale (QOLOD) Score
Quality Of Life, Obesity and Dietetics rating scale (QOLOD) includes 36 items designed to assess quality of life in 5 domains: physical impact, psycho-social impact, impact on sex life , comfort with food, and diet experience The variables of interest will be the 5 subscales scores
Measured: 6 months (T2)
Number of sessions completed (Compliance)
Compliance at group session will correspond to the number of sessions completed out of the 10 proposed group sessions.
Measured: After the 10th session (S10)
Patient Satisfaction Questionnaire (PSQ) Score
Patient Satisfaction Questionnaire (PSQ) includes 6 domains of satisfaction that are rated on a 10-points Likert scale as well as 2 open questions on what was helpful and what could be improved. For both groups (i.e experimental intervention and control intervention), the variable of interest will be the a mean total score of satisfaction in each of the 6 domains. In addition, for the group receiving the experimental intervention, scores of satisfaction in each of the 6 domains will be described separately for the CRT, EST and CBT modules of the intervention
Measured: After the 3rd session (Week 3)
Patient Satisfaction Questionnaire (PSQ) Score
Patient Satisfaction Questionnaire (PSQ) includes 6 domains of satisfaction that are rated on a 10-points Likert scale as well as 2 open questions on what was helpful and what could be improved. For both groups (i.e experimental intervention and control intervention), the variable of interest will be the a mean total score of satisfaction in each of the 6 domains. In addition, for the group receiving the experimental intervention, scores of satisfaction in each of the 6 domains will be described separately for the CRT, EST and CBT modules of the intervention
Measured: After the 6th session (Week 6)
Patient Satisfaction Questionnaire (PSQ) Score
Patient Satisfaction Questionnaire (PSQ) includes 6 domains of satisfaction that are rated on a 10-points Likert scale as well as 2 open questions on what was helpful and what could be improved. For both groups (i.e experimental intervention and control intervention), the variable of interest will be the a mean total score of satisfaction in each of the 6 domains. In addition, for the group receiving the experimental intervention, scores of satisfaction in each of the 6 domains will be described separately for the CRT, EST and CBT modules of the intervention
Measured: After the 9th session (Week 9)
Motivation to change Score
Motivation to change will be assessed explore beliefs about the importance to change and perceived ability to change. Rating scores are based on a Likert 0-10 scale. Higher scores indicate more positive beliefs about one's importance/ability to change. These two scores will be used as variables of interest
Measured: 12 weeks (T1)
Revised Helping Alliance Questionnaire (HAQ-11) Score
Revised Helping Alliance Questionnaire (HAQ-11) is a 11-item questionnaire that measures the strength of the patient-therapist therapeutic alliance. A total score is obtained by summing the item scores. The variable of interest will be the HAQ-11total score
Measured: 12 weeks (T1)
Ecological Momentary Assessment data collection
will be acquired by 5 signal-based assessments per day. One random assessment Ecological Momentary Assessment data collection will occur during each of the following time periods: 9:00 am to 11:00 am; 11:00 am to 2:00 pm; 2:00 pm to 5:00 pm; 5:00 pm to 8:00 pm; and 8:00 pm to 10:00 pm during 7 days. The questions administered after random prompt will include items relative to eating behaviors, craving and food intake, exposure to food cues, positive and negative affectivity, the experience of stress (type of stress and level of perceived stress), other personal states, cognitive functioning, craving and emotional regulation strategies.
Measured: During 7 days after baseline
Ecological Momentary Assessment data collection
will be acquired by 5 signal-based assessments per day. One random assessment Ecological Momentary Assessment data collection will occur during each of the following time periods: 9:00 am to 11:00 am; 11:00 am to 2:00 pm; 2:00 pm to 5:00 pm; 5:00 pm to 8:00 pm; and 8:00 pm to 10:00 pm during 7 days. The questions administered after random prompt will include items relative to eating behaviors, craving and food intake, exposure to food cues, positive and negative affectivity, the experience of stress (type of stress and level of perceived stress), other personal states, cognitive functioning, craving and emotional regulation strategies.
Measured: During 7 days after the 10th session (Week 10 to week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start15 Nov 2021
- Primary completion23 Mar 2024
- Study completion19 Aug 2024
Why it stopped: target number of inclusion not reached
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Mélina FATSEAS, Principal investigator, University Hospital, BordeauxSylvie BERTHOZ, Study director, CNRS UMR 5287 - INCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338178
- Sponsor's protocol ID
- CHUBX 2017/50
- Acronym
- OBESADEM
- Status last verified
- Jul 2025
- First submitted
- 3 Apr 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multi-component Treatment Program Integrating Cognitive - Affective - Addictive Based Intervention in Obese Patients: a Prospective Multicentric Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04338178
- Acronym / sponsor ID
- OBESADEM / CHUBX 2017/50
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of inclusion not reached
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 23 Mar 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 8 Apr 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention | Experimental | Behavioral: Cognitive Remediation Therapy (CRT), Behavioral: Emotional Skills Training (EST), Behavioral: Cognitive Behavioral TherapyStandard outpatient program, with additional group sessions integrating the experimental intervention : Cognitive Remediation Therapy (CRT), Emotional Skills Training (EST), and Cognitive Behavioral Therapy focused on craving and food addiction (CBT), delivered once a week during 10 weeks. |
| Standard intervention | Active comparator | Procedure: Multidisciplinary outpatient programStandard outpatient program, with additional group sessions integrating control intervention : multidisciplinary outpatient program including several consultations with endocrinologists, dietitians, psychologists, nutritionists and/or physical activity coaches, delivered once a week during 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 Remediation Therapy (CRT)This intervention consists of mental exercises aimed at improving executive function via practice. Simple cognitive tasks that encourage reflective learning and insight into patient's own thinking process are administered. Exercises target set-shifting (i.e., cognitive flexibility), estimating, organization and planning. | Behavioural | Experimental intervention |
| Emotional Skills Training (EST)EST places emphasis on the improvement of inner emotion awareness, facial and body expression recognition and intra- and interpersonal emotion regulation skills. Different modules and interactive exercises are designed to help patients learn about i) the functions and manifestations of emotions, ii) the identification and labelling of own's and others' emotions, iii) tolerating and communicating emotions, and iiii) balancing between negative and positive emotions. | Behavioural | Experimental intervention |
| Cognitive Behavioral TherapyCBT intervention aimed to manage food craving by teaching group members cognitive (e.g., restructuring of urge-related thoughts) and behavioural strategies (e.g., increasing awareness through food diaries, relaxation skills, identification of cues that trigger craving, avoidance of high-risk situations for craving, distraction). | Behavioural | Experimental intervention |
| Multidisciplinary outpatient programMultidisciplinary outpatient program including several consultations with endocrinologists, dietitians, psychologists, nutritionists and/or physical activity coaches. Patients are regularly followed and educated about the importance of lifestyle changes including healthy dietary habits and exercise in weight reduction and maintenance. Patients are also usually given information about nutritional value of various foods and few simple exercises for decreasing and maintaining body weight. This program is therefore planned as part of the usual care and responds to the recommendations of good practice for obesity | Procedure or surgery | Standard intervention |
Primary outcome
Change in Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score
Time frame: Baseline (T0) and 12 weeks (T1)
Self-administered questionnaire consisting of 15 items assessing several aspects of food craving: lack of control over eating, thoughts or preoccupation with food, intentions and plans to consume food, emotions before or during food craving, cues that may trigger food craving
36 secondary outcomes
Body mass index (BMI)
Time frame: 12 weeks (T1)
Body mass index (BMI)
Time frame: 6 months (T2)
Waist circumference
Time frame: 12 weeks (T1)
Waist circumference
Time frame: 6 months (T2)
Percentage of body fat and fat-free mass
Time frame: 12 weeks (T1)
Percentage of body fat and fat-free mass
Time frame: 6 months (T2)
Emotional Appetite Questionnaire (EMAQ) Score
Time frame: 12 weeks (T1)
Emotional Appetite Questionnaire (EMAQ) Score
Time frame: 6 months (T2)
Eating Disorder Examination-Questionnaire (EDE-Q) Score
Time frame: 12 weeks (T1)
Eating Disorder Examination-Questionnaire (EDE-Q) Score
Time frame: 6 months (T2)
Dutch Eating Behaviour Questionnaire (DEBQ) Score
Time frame: 12 weeks (T1)
Dutch Eating Behaviour Questionnaire (DEBQ) Score
Time frame: 6 months (T2)
modified Yale Food Addiction Scale (mYFAS) Assessment
Time frame: 12 weeks (T1)
modified Yale Food Addiction Scale (mYFAS) Assessment
Time frame: 6 months (T2)
Psychiatric disorders assessment using the Mini International Neuropsychiatric Interview (MINI)
Time frame: 6 months (T2)
Interviewer Severity Rating (ISR) established for Addiction Severity Index (ASI)
Time frame: 6 months (T2)
Trail Making Test (TMT) completion time and number of perseverative errors
Time frame: 12 weeks (T1)
Wisconsin Card Sorting Test 64 (WCST) number and percentage of perseverative errors
Time frame: 12 weeks (T1)
Zoo test Score
Time frame: 12 weeks (T1)
UPPS Impulsive Behavior Scale Score
Time frame: 12 weeks (T1)
Monetary Choice Questionnaire (MCQ)
Time frame: 12 weeks (T1)
Performances (flexibility) at the Stroop and Verbal Fluency computerized tests (EMA).
Time frame: 12 weeks (T1)
Difficulties in Emotion Regulation Scale (DERS) Score
Time frame: 12 weeks (T1)
Difficulties in Emotion Regulation Scale (DERS) Score
Time frame: 6 months (T2)
Depression Anxiety Stress Scales (DASS-21) Score
Time frame: 12 weeks (T1)
Depression Anxiety Stress Scales (DASS-21) Score
Time frame: 6 months (T2)
Quality Of Life, Obesity and Dietetics rating scale (QOLOD) Score
Time frame: 12 weeks (T1)
Quality Of Life, Obesity and Dietetics rating scale (QOLOD) Score
Time frame: 6 months (T2)
Number of sessions completed (Compliance)
Time frame: After the 10th session (S10)
Patient Satisfaction Questionnaire (PSQ) Score
Time frame: After the 3rd session (Week 3)
Patient Satisfaction Questionnaire (PSQ) Score
Time frame: After the 6th session (Week 6)
Patient Satisfaction Questionnaire (PSQ) Score
Time frame: After the 9th session (Week 9)
Motivation to change Score
Time frame: 12 weeks (T1)
Revised Helping Alliance Questionnaire (HAQ-11) Score
Time frame: 12 weeks (T1)
Ecological Momentary Assessment data collection
Time frame: During 7 days after baseline
Ecological Momentary Assessment data collection
Time frame: During 7 days after the 10th session (Week 10 to week 11)
Results and safety
The study was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mélina FATSEAS principal investigator
University Hospital, Bordeaux
Sylvie BERTHOZ study director
CNRS UMR 5287 - INCIA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy (CRT), Emotional Skills Training (EST) and Cognitive Behavioral Therapy in people with Obesity and Craving, run by University Hospital, Bordeaux at 3 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: target number of inclusion not reached). Results are not available in the source record.
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?
Change in Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score (time frame: Baseline (T0) and 12 weeks (T1)). 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 22 May 2026.