Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 18
- 主要终点
- Percentage of patients without food addiction
研究概览
简要总结
Morbid or severe obesity is a chronic pathology of multifactorial etiology that affects 4.3% of the French population. In these patients, eating disorders are frequent and must be managed as they are considered risk factors with poorer weight prognosis and lower quality of life.
Some authors have proposed that the concept of food addiction (i.e., the existence of an addiction to certain foods rich in sugar, fat and/or salt) may make it possible to identify, among obese patients, a subgroup of patients that is more homogeneous in terms of diagnosis and prognosis.
Food addiction is common in obese patients and is associated with higher levels of depression, anxiety, impulsivity, emotional eating and poorer quality of life. Nevertheless, we do not know the impact of managing this addiction on the future of these patients (food addiction, weight, comorbidities, quality of life). Telephone-based cognitive behavioral therapy intervention (Tele-CBT) is a treatment of choice for addictions, but there are inequalities in access to this treatment (distance between home and hospital, limited local resources of caregivers, constraints in patient availability) which require the therapeutic framework to be adapted to these constraints. A short Tele-CBT program has demonstrated its effectiveness in reducing bulimic hyperphagia in these patients (Cassin et al. 2016), but its effectiveness on food addiction, Body Mass Index and the evolution of metabolic complications related to obesity is still unknown. The evaluation of this program was limited to 6 weeks (American study), and we do not know if these results can also be extrapolated to France.
The main hypothesis of this study is that in patients suffering from severe or morbid obesity and with food addiction, the performance of tele-CBT (intervention group: 12 sessions for 18 weeks) will be accompanied by a significant medium-term decrease in the prevalence of food addiction compared to usual management (control group).
详细描述
Morbid or severe obesity is a chronic pathology of multifactorial etiology that affects 4.3% of the French population. In these patients, eating disorders are frequent and must be managed as they are considered risk factors with poorer weight prognosis and lower quality of life.
Some authors have proposed that the concept of food addiction (i.e., the existence of an addiction to certain foods rich in sugar, fat and/or salt) may make it possible to identify, among obese patients, a subgroup of patients that is more homogeneous in terms of diagnosis and prognosis.
Food addiction is common in obese patients and is associated with higher levels of depression, anxiety, impulsivity, emotional eating and poorer quality of life. Nevertheless, we do not know the impact of managing this addiction on the future of these patients (food addiction, weight, comorbidities, quality of life). Telephone-based cognitive behavioral therapy intervention (Tele-CBT) is a treatment of choice for addictions, but there are inequalities in access to this treatment (distance between home and hospital, limited local resources of caregivers, constraints in patient availability) which require the therapeutic framework to be adapted to these constraints. A short Tele-CBT program has demonstrated its effectiveness in reducing bulimic hyperphagia in these patients (Cassin et al. 2016), but its effectiveness on food addiction, Body Mass Index and the evolution of metabolic complications related to obesity is still unknown. The evaluation of this program was limited to 6 weeks (American study), and we do not know if these results can also be extrapolated to France.
The main hypothesis of this study is that in patients suffering from severe or morbid obesity and with food addiction, the performance of tele-CBT (intervention group: 12 sessions for 18 weeks) will be accompanied by a significant medium-term decrease in the prevalence of food addiction compared to usual management (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •BMI ≥35kg/m² (morbid or severe obesity)
- •First appointment to a physician specialized in nutrition
- •"Food addiction diagnosis" according to the YFAS 2.0
- •Affiliated to the French national health service
- •Consent signed
排除标准
- •Difficulties in understanding the self-administered questionnaires, including illiteracy
- •Impossibility to participate to the CBT sessions (i.e., no phone, scheduled unavailability)
- •Not eligible for CBT (i.e., cognitive disorders, hearing disorders)
- •Antecedent of monogenic or oligogenic obesity (MC4R mutation)
- •Severe alcohol use disorder (at least 6 out of 11 DSM-5 criteria for alcohol use disorder)
- •Current medication with a significant adverse effect on eating behavior (i.e., lithium, neuroleptic/antipsychotic)
- •Discrepancy between self-administered questionnaires and the clinical interview conducted prior to inclusion (for the assessment of food addiction diagnosis).
- •Condition associated with important weight variations (i.e., oedema related to severe cardiac insufficiency, renal insufficiency, hepatic insufficiency with cirrhosis, exudative enteropathy)
- •Participation to another psychological or pharmacological interventional study that could impact our primary or secondary outcomes
- •Wearing a pace-maker or metal prosthesis
- •Person under tutorship or curatorship
结局指标
主要结局
Percentage of patients without food addiction
时间窗: 18 weeks after randomization
Yale Food Addiction Scale 2.0 (food addiction is defined by the existence of at least 2 out of 11 criteria for food addiction and associated emotional distress)
次要结局
- Evolution of quality of life(From baseline, up to 9 months)
- Evolution of the waist-to-hip ratio(From baseline, up to 9 months)
- Evolution of Percentage of patients without food addiction during follow-up(From baseline, up to 9 months)
- Evolution of Body Composition(From baseline, up to 9 months)
- Existence and evolution of food cravings(From baseline, up to 9 months)
- Weight/BMI evolution(From baseline, up to 9 months)
- Existence and evolution of an alcohol use disorder(From baseline, up to 9 months)
- Evolution of number of criteria for food addiction(From baseline, up to 9 months)
- Existence and evolution psychiatric and addictive disorders(From baseline, up to 18 weeks)
- Existence and evolution of depression(From baseline, up to 9 months)
- Existence and evolution of bulimic hyperphagia(From baseline, up to 9 months)
- Existence and evolution of a Smoking Disorder(From baseline, up to 9 months)
- Existence and evolution of emotional eating(From baseline, up to 9 months)