Efficacy of a Multi-component Treatment Program Integrating Cognitive - Affective - Addictive Based Intervention in Obese Patients: a Prospective Multicentric Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 144
- Locations
- 3
- Primary Endpoint
- Change in Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- modified Yale Food Addiction Scale (mYFAS) Assessment(6 months (T2))
- Waist circumference(6 months (T2))
- Body mass index (BMI)(6 months (T2))
- Percentage of body fat and fat-free mass(6 months (T2))
- Emotional Appetite Questionnaire (EMAQ) Score(6 months (T2))
- Eating Disorder Examination-Questionnaire (EDE-Q) Score(6 months (T2))
- Dutch Eating Behaviour Questionnaire (DEBQ) Score(6 months (T2))
- Interviewer Severity Rating (ISR) established for Addiction Severity Index (ASI)(6 months (T2))
- Psychiatric disorders assessment using the Mini International Neuropsychiatric Interview (MINI)(6 months (T2))
- Trail Making Test (TMT) completion time and number of perseverative errors(12 weeks (T1))
- Wisconsin Card Sorting Test 64 (WCST) number and percentage of perseverative errors(12 weeks (T1))
- Zoo test Score(12 weeks (T1))
- Monetary Choice Questionnaire (MCQ)(12 weeks (T1))
- UPPS Impulsive Behavior Scale Score(12 weeks (T1))
- Performances (flexibility) at the Stroop and Verbal Fluency computerized tests (EMA).(12 weeks (T1))
- Quality Of Life, Obesity and Dietetics rating scale (QOLOD) Score(6 months (T2))
- Number of sessions completed (Compliance)(After the 10th session (S10))
- Difficulties in Emotion Regulation Scale (DERS) Score(6 months (T2))
- Depression Anxiety Stress Scales (DASS-21) Score(6 months (T2))
- Patient Satisfaction Questionnaire (PSQ) Score(After the 9th session (Week 9))
- Motivation to change Score(12 weeks (T1))
- Revised Helping Alliance Questionnaire (HAQ-11) Score(12 weeks (T1))
- Ecological Momentary Assessment data collection(During 7 days after the 10th session (Week 10 to week 11))