跳至主要内容
临床试验/NCT05598840
NCT05598840已完成不适用

Randomized Clinical Trial to Assess the Efficacy of a Mobile Application to Help in Weight Loss Before Bariatric Surgery: the VAMOS Project (Virtual Accompaniment for Morbid Obesity Surgery)

Hospital Universitari de Bellvitge1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2022年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
142
试验地点
1
主要终点
Preoperative weight loss

研究概览

简要总结

The present randomized clinical trial aims to prove the safety and efficacy of an interactive mobile application (Care4Today®) to obtain sufficient weight loss and empower patients with morbid obesity before being submitted to a gastric by-pass.

详细描述

Morbid obesity is considered the great epidemic of our century. It is regarded as the first non-traumatic cause of death in the western population and it is also progressively beginning to affect developing countries. The latest epidemiological studies estimate that in Spain more than 15% of the population has overweight and about 5% has morbid obesity.

Obesity treatment is multidisciplinary, from lifestyle and dietary changes to surgery. Amongst the different available treatments, bariatric surgery is the only cost-effective in patients with morbid obesity. Bariatric surgery provides better results compared to both pharmacological treatments (which are less available and less effective) and lifestyle changes. Furthermore, as well as weight loss, it guarantees a better control of comorbidities, reducing the risk of cardiovascular disease, morbidity and mortality, improving quality of life.

Although surgery is the best treatment option, patient commitment is necessary to achieve satisfactory results. Obtaining patient's comprehension of the importance of healthy lifestyle and equilibrated diet alongside with surgical information is generally difficult. Patient's concern needs to be constantly stressed out. The ongoing protocols that include preoperative meetings with surgeons, endocrinologists and nutritionists have been proved as insufficient, especially during the Covid-19 pandemic, when presential visits were reduced or cancelled.

Preoperative optimization with a healthy lifestyle and a balanced diet few months before surgery potentially reduce intraoperative complications alongside with postoperative morbidity and mortality. Level of physical activity, diet and psychological stability could affect surgery's outcome for example reducing liver volume (up to 20%) and mesenteric fat. Also, an improvement in patient's preoperative satisfaction, anxiety and commitment to surgery have been suggested. Their impact on postoperative outcomes is unclear. There is lack of consensus on a standardized preoperative approach and goals. Many health care professionals worldwide strongly believe that preoperative optimization has an important impact on postoperative outcomes, but the evidence supporting this belief is mixed and most often retrospective. Although a positive relationship between self-monitoring behaviors (such as daily food intake diaries and regular self-weighing) and weight loss has been proved, additional instruction and behavioral intervention are needed. Besides weight loss, other factors such as adherence to self-monitoring of weight, recording food intake, increased physical activity could influence postoperative outcomes.

Even though official guidelines for an enhanced recovery (ERAS, Enhanced Recovery After Surgery) in bariatric surgery recommend patient information, education, counseling and preoperative weight loss, the efficacy of these measures has not been proved.

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

入选标准

  • Patients older than 18 and younger than 65 years who meet criteria to undergo bariatric surgery
  • BMI between 35 and 50 kg/m2 and indication of one-time surgery
  • Signing the informed consent of the study
  • Patient suitable for laparoscopic surgery
  • Patient who demonstrates accessibility to a smartphone and basic digital competence

排除标准

  • Previous bariatric surgery
  • Two-step surgery
  • Patient without resources to access the use of a Smartphone or without basic digital competence
  • Contraindication for surgery
  • Other surgical procedures associated with the same intervention

研究组 & 干预措施

Normal VLCD (Very Low Calory Diet) group

Active Comparator

Normal preoperative standard protocol will be provided to all the patients randomized in the normal group.

干预措施: Very low calory diet (Behavioral)

APP group

Experimental

Four months before surgery, the C4T APP, in addition to standard protocol, will be provided to all the patients randomized in the APP group.

干预措施: Very low calory diet (Behavioral)

APP group

Experimental

Four months before surgery, the C4T APP, in addition to standard protocol, will be provided to all the patients randomized in the APP group.

干预措施: Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery. (Behavioral)

结局指标

主要结局

Preoperative weight loss

时间窗: App will be provided four months before surgery and then preoperative weight loss achieved will be evaluated the day of surgery

To compare patients' preoperative weight loss after using the C4T APP versus the standard preoperative protocol.

次要结局

  • patient satisfaction using the APP(App will be provided four months before surgery and patients' information/satisfaction using the APP will be evaluated the day of surgery)
  • patient information using the APP(App will be provided four months before surgery and patients' information/satisfaction using the APP will be evaluated the day of surgery)
  • Correlation between preoperative weight loss and Early postoperative weight loss(Patients' weight loss in each group will be evaluated and compared 3 months after surgery)
  • Correlation between preoperative weight loss and early complications(Early complication rate in each group will be evaluated and compared 30 and 90 days postoperative)

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Osorio

Chief of Bariatric and Metabolic surgical Unit

Hospital Universitari de Bellvitge

研究点 (1)

Loading locations...

相似试验