Efficacy of a Mobile Application to Help in Weight Loss Before Bariatric Surgery
Condition: Morbid Obesity; Weight Loss
MeSH terms: Obesity; Obesity, Morbid; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Technological development is an important resource that could help improving communications
      between patients and health care professionals. Nowadays, the use of a smartphone is widely
      integrated in daily life of most people. The number of smartphones used is constantly
      increasing every year. In 2016, there were more than seven billion users worldwide. The
      worldwide fast widespread of mobile technology in the last 15 years led to an expansion of
      the applications (APP) market. To date, the biggest APP market are 'Google Play' (Android),
      'App store' (Apple) and 'Blackberry World' (Blackberry).

      This technological revolution has progressively affected the health world. An increasing
      number of medical APP have been designed in the last years, few directly managed from health
      care providers from public or private centers. The Mobile Health APP could led to a simpler,
      real-time connection between patients and health care professionals alongside with a
      bidirectional data flow and a steadily monitorization of patients' evolution that could
      obtain a better preoperative follow-up without increasing the costs.

      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.
    

Intervention name(s): Care for today Mobile Application
Intervention type(s): Other
Intervention description(s): C4T (Care for Today) Education is a digital application (app) designed to offer quality educational materials.
The APP will be provided to the patients in the outpatient centre four months before surgery. Patients will be able to download the APP using a QR code that will be provided during the visit. They'll realize the download immediately or at home, in both cases a detailed explication of how to use the APP and its contents will be provided using an example version.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobile APP; Obesity; R-en-Y gastric bypass; Preoperative weight loss