Efficacy of a Mobile Application and Semi-attendance Program in Bariatric Surgery: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Weight loss
研究概览
简要总结
BACKGROUND: Applications for mobile devices in patients with obesity offer a great opportunity to improve the quality of care and the monitoring of patients in bariatric surgery programs. This is especially pressing in the context of an increasing prevalence of obesity, and longer waiting lists in bariatric surgery programs.
OBJECTIVES: The main objective is to evaluate the efficacy of a digital platform on mobile devices in obesity and bariatric surgery programs. Investigators will compare weight loss at 12 months after surgery in patients in the standard of care program and those in a semi-attendance program with digital support through a mobile application. As secondary objectives, it will be compared: (1) the number medical complications, the quality of life and satisfaction, physical activity, diet and attrition at 12 months after surgery. Investigators will also study the patient interaction with the platform and social networks.
TRIAL DESIGN: Randomized, non-inferiority clinical trial with a 12-month follow-up.
METHODS: 72 patients will be randomized (1: 1) to standard of care program and to semi-attendance program with digital support from the bariatric surgery program waiting list. Inclusion criteria: age between 18 and 60 years, body mass index between 35-50kg/m2, candidates for the sleeve gastrectomy technique, and possession of a mobile device. Participants will be evaluated before and 12 months after surgery. Variables: anthropometric measurements, medical complications during follow-up, quality of life, diet and physical activity questionnaires. Primary endpoint: weight loss 12 months after surgery.
详细描述
Introduction
In Spain, the prevalence of obesity in adults has increased from 14% to 21.6% between 2003 and 2016. The category of obesity that has increased the most is severe obesity. Forecasts for the next ten years maintain that the increase will continue.
The two main problems of current bariatric surgery programs are the saturation of healthcare resources, and the losses to follow-up and long-term treatment adherence. Patients on the waiting list for bariatric surgery and who have completed the preoperative program can be found for a long period in a situation where there is no proactive specialized follow-up and without ability to consult with a multidisciplinary team.
On the other hand, loss to follow-up is another unresolved problem currently in bariatric units. Longer follow-up by specialized units has been associated with greater long-term weight loss. However, the loss to follow-up at 5 years can be as high as 40%, and even higher in the longer term. The already existing saturation of resources prior to the COVID-19 pandemic and the new limitations generated by it, have highlighted the need to reformulate bariatric surgery programs.
In this sense, the incorporation of digital platforms and applications for mobile devices can contribute to the digital transformation of the health care system to severe obesity.
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
- 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
- •BMI between 35-50kg/m2
- •Bariatric surgery candidates
排除标准
- •Non-controlled psychiatric disorder
- •Pregnancy desire in the next 12 months
- •Do not have mobile devices (smartphone)
- •Language barrier with Spanish.
研究组 & 干预措施
Semi-attendance.
This group will follow a semi-attendance program after bariatric surgery.
干预措施: Obemar platform (Other)
Control group.
This group will follow the conventional controls after bariatric surgery.
结局指标
主要结局
Weight loss
时间窗: 1 year
The percentage of total weight loss at 12 months after bariatric surgery.
次要结局
- Diet quality.(1 year)
- Medical-surgical complications.(1 year)
- Degree of satisfaction and quality of life.(1 year)
- Degree of physical activity.(1 year)
- Cost analysis.(1 year)
- Loss to follow-up.(1 year)