Efficacy of a Cognitive - Affective - Addictive Based Intervention to Decrease Food Craving in Obese Patients.

NCT04338178 | Terminated

• 1 other identifier: CHUBX 2017/50
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity; Craving; Cognitive Behavioral Therapy; Cognitive Remediation Therapy; Addiction

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (T0) and 12 weeks (T1)

Secondary Outcomes (36)

• Body mass index (BMI)

  12 weeks (T1)

• Body mass index (BMI)

  6 months (T2)

• Waist circumference

  12 weeks (T1)

• Waist circumference

  6 months (T2)

• Percentage of body fat and fat-free mass

  12 weeks (T1)

Study Arms (2)

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.

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.

Procedure: Multidisciplinary outpatient program

Interventions

Cognitive Remediation Therapy (CRT) BEHAVIORAL

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.

Experimental intervention

Emotional Skills Training (EST) BEHAVIORAL

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.

Experimental intervention

Cognitive Behavioral Therapy BEHAVIORAL

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).

Experimental intervention

Multidisciplinary outpatient program PROCEDURE

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

Standard intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Treatment seeking obese patients (30 kg/m2 ≤ BMI ≤ 45 kg/m2)
• Able to participate in group sessions once a week for 10 weeks
• Affiliated person or beneficiary of a social security scheme

You may not qualify if:

• 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
• Be deprived of liberty due to an ongoing legal procedure
• Pregnancy or breastfeeding
• Individuals under legal protection or unable to express personally their consent

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (3)

Assistance Publique Hôpitaux de Paris Hôpital Européen Georges Pompidou

Paris, 75 015, France

Location

Assistance Publique Hôpitaux de Paris Hôpital Ambroise Paré

Paris, 92 100, France

Location

CHU de Bordeaux

Pessac, 33600, France

Location

MeSH Terms

Conditions

Obesity; Behavior, Addictive

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mélina FATSEAS

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Sylvie BERTHOZ

  CNRS UMR 5287 - INCIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 8, 2020
• Study Start: November 15, 2021
• Primary Completion: March 23, 2024
• Study Completion: August 19, 2024
• Last Updated: May 22, 2026

Record last verified: 2025-07

Locations

FR (3)