Randomised Trial of Comprehensive, Intensive, On-site Behavioural Lifestyle Intervention Versus Usual Care During the Preoperative Preparation for Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Changes in body weight
研究概览
简要总结
Prospective randomized clinical trial aiming to compare a comprehensive, intensive behavioral lifestyle intervention and usual care during the preoperative preparation to bariatric surgery, with primary outcome on excess weight loss and secondary outcomes on patient's physical status, quality of life, comorbidity and technical difficulty of the surgery.
详细描述
Obesity is a complex, multifactorial pathology that has major public health importance. Lifestyle modification is the cornerstone of all obesity treatments, including surgery. Throughout the non-surgical treatment options, high-intensity, on-site comprehensive lifestyle intervention has demonstrated the best efficacy in obtaining weight loss, but with a risk of progressive weight regain, after 6 months (1). In obese adults, bariatric surgery produces greater weight loss and weight loss maintenance than the conventional medical treatment and lifestyle intervention (1).
There is no consensus on whether combining these two approaches (i.e. high-intensity, on-site comprehensive lifestyle intervention and bariatric surgery) results in enhanced weight loss or more sustainable outcomes. The present randomized trial aims to answer this question.
Patients preparing for bariatric surgery will be randomized between two groups. The first group will receive the usual care as recommended by the French Health Authority ("Haute Autorité de santé"), including 6 months of endocrine and nutritional follow-up and educational intervention. The second group will receive a high-intensity, 4 weeks on-site comprehensive lifestyle intervention, including prescription of a moderately reduced-calorie diet, a program of increased physical activity, and behavioral management. The patients from both groups will then be operated on and followed for at least 2 years. Complete work-up, including clinical examination, comorbidity assessment, MRI of the liver, thigh and abdominal fat, 6 minutes' walk test, quality of life questionnaires will be performed at the begging of the follow-up, after the preparation (usual care or intensive) and 2 years after surgery. Clinical and biological assessment will be performed regularly after surgery, and technical details from the bariatric interventions will be analyzed in order to assess the eventual facilitation of the gestures in the intervention 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
- •Patient with a BMI (Body Mass Index) of 40 or BMI of 35 with associated comorbidity and who desires obesity surgery
- •Patient agreeing to participate in the study, including the 2 years follow-up
- •Patient accepting the constraints of the study related to the group to which he/she will be assigned as a result of randomization (availability to his work, his family, etc.)
- •Patient able to receive and to understand the study information and to give written informed consent
- •Patient affiliated with the French social security system
排除标准
- •Patient with a BMI of more than 60
- •Patient with contraindication to laparoscopic obesity surgery
- •Patient already operated on for obesity
- •Patient with a history of major abdominal surgery
- •Patient with contraindications to MRI:
- •pace maker or automatic defibrillator, implanted insulin pump
- •auditory neurostimulator, anal neurostimulator, etc.
- •ferromagnetic bodies in soft tissues, intraocular foreign bodies, cerebral vascular clips
- •claustrophobia
- •morphotype not allowing access to MRI: morbid obesity with waist circumference greater than 150 cm, shoulder width greater than 59 cm
- •Patient with psychiatric pathology (untreated psychosis, drug dependence, etc.)
- •Pregnant or breast-feeding patient
- •Patient in periods of exclusion (determined by a previous or ongoing study)
- •Patient under safeguard of justice
- •Patient under guardianship
研究组 & 干预措施
Usual Care
The patients in this arm will have usual care during preoperative period, bariatric surgery and follow-up.
干预措施: Preoperative usual care (Behavioral)
UGECAM
During the preoperative period, the patients in this arm will have usual care and a 4 weeks intensive, comprehensive behavioral lifestyle intervention. They will then have usual bariatric surgery and follow-up.
干预措施: Preoperative intensive behavioral lifestyle intervention (Behavioral)
结局指标
主要结局
Changes in body weight
时间窗: Before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery
Changes in body weight
Excess weight loss
时间窗: 2 years after surgery
The percentage of excess weight loss is obtained as follow: (initial body weight - body weight at 2 years postoperatively) / (initial body weight - ideal body weight at BMI 25) x 100
Changes in Body Mass Index (BMI)
时间窗: Before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery
Changes in Body Mass Index, obtained as follow: body weight (in kilograms)/ the square of height (in meters)
次要结局
- Comparison of surgical difficulty in terms of postoperative hospitalisation duration(At time of surgery)
- Changes in the quality of life by the mean of a quality of life questionnaire specialized in bariatric surgery(before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery)
- Changes in iron overload in the liver(Before preparation, before surgery and 24 months after surgery)
- Changes in surgical difficulty in terms of left liver volume(Before preparation, before surgery and 24 months after surgery)
- Changes in surgical difficulty in terms of visceral flat volume(Before preparation, before surgery and 24 months after surgery)
- Comparison of surgical difficulty in terms of surgery duration(At time of surgery)
- Comparison of surgical difficulty in terms of gastric pouch positioning duration(At time of surgery)
- Changes in the remission rate of fatty liver(Before preparation, before surgery and 24 months after surgery)
- Changes in liver elasticity(Before preparation, before surgery and 24 months after surgery)
- Changes in the physical status in terms of muscle/fat report(Before preparation, before surgery and 24 months after surgery)
- Changes in the physical status in terms of waist circumference(before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery)
- Changes in LDL cholesterol levels(Before preparation, before surgery and 24 months after surgery)
- Surgical complication assessment(Up to 24 months after surgery)
- Changes in the physical status in terms of walking abilities(before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery)
- Changes in physical status in terms of hip circumference(before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery)
- Changes in the quality of life by the mean of the Gastrointestinal Quality of Life Index (GIQLI)(before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery)
- Changes in insulin resistance(Before preparation, before surgery and 24 months after surgery)