Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05598840 |
| Other study ID # |
HUB-VAMOS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 18, 2022 |
| Est. completion date |
November 1, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Hospital Universitari de Bellvitge |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
