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

University Hospital of Bordeaux

Status: Completed

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

Treatments: Procedure: Multidisciplinary outpatient program; Behavioral: Emotional Skills Training (EST); Behavioral: Cognitive Behavioral Therapy; Behavioral: Cognitive Remediation Therapy (CRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04338178

CHUBX 2017/50

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups

Experimental intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Remediation Therapy (CRT)

Behavioral: Cognitive Behavioral Therapy

Behavioral: Emotional Skills Training (EST)

Standard intervention

Active Comparator group

Description:

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.

Treatment:

Procedure: Multidisciplinary outpatient program