跳至主要内容
临床试验/NCT04338178
NCT04338178终止不适用

Efficacy of a Multi-component Treatment Program Integrating Cognitive - Affective - Addictive Based Intervention in Obese Patients: a Prospective Multicentric Randomized Clinical Trial

University Hospital, Bordeaux6 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2021年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
144
试验地点
6
主要终点
Change in Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Cognitive Remediation Therapy (CRT) (Behavioral)

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.

干预措施: Emotional Skills Training (EST) (Behavioral)

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.

干预措施: Cognitive Behavioral Therapy (Behavioral)

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.

干预措施: Multidisciplinary outpatient program (Procedure)

结局指标

主要结局

Change in Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score

时间窗: 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

次要结局

  • 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))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (6)

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