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Morbid ObesityVAMOSNCT05598840

Efficacy of a Mobile Application to Help in Weight Loss Before Bariatric Surgery

A study testing Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery. and Very low calory diet in people with Morbid Obesity and Weight Loss, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Morbid Obesity, Weight Loss
What is being tested?
Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery. and Very low calory diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteSpain
Study dates
18 Oct 2022to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

Official title: 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)

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.

Read the 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.

Being tested
Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery., Very low calory diet
Keywords
Mobile APP, Obesity, R-en-Y gastric bypass, Preoperative weight loss
Medical subject headings
Obesity, Morbid, Weight Loss, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery.Behavioural

    Multimodal digital prehabilitation programme for candidates undergoing bariatric surgery.

  • Very low calory dietBehavioural

    Standard follow-up with very-low calory diet

Study groups in NCT05598840
Study groupRoleWhat they receive
APP groupExperimentalFour months before surgery, the C4T APP, in addition to standard protocol, will be provided to all the patients randomized in the APP group.
Receives: Behavioral: Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery.; Behavioral: Very low calory diet
Normal VLCD (Very Low Calory Diet) groupActive comparatorNormal preoperative standard protocol will be provided to all the patients randomized in the normal group.
Receives: Behavioral: Very low calory diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preoperative weight loss

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

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

Secondary outcomes (4)
  1. patient information using the APP

    A validated questionnaire will be used to compare patients' information using the APP vs. standard protocol. (10 questions, 1 point each: >6 good information achieved).

    Measured: App will be provided four months before surgery and patients' information/satisfaction using the APP will be evaluated the day of surgery

  2. patient satisfaction using the APP

    A validated questionnaire (will be used to compare patients' satisfaction using the APP vs. standard protocol. (10 items to evaluate as very poor, poor, correct, good, excellent).

    Measured: App will be provided four months before surgery and patients' information/satisfaction using the APP will be evaluated the day of surgery

  3. Correlation between preoperative weight loss and early complications

    Compare complications in the immediate postoperative period (30- and 90-days post-intervention) after the preoperative use of APP vs. standard protocol. Complications will be recorded in our prospective database.

    Measured: Early complication rate in each group will be evaluated and compared 30 and 90 days postoperative

  4. Correlation between preoperative weight loss and Early postoperative weight loss

    Compare patients' weight loss 3 months after surgery using the APP vs. standard protocol

    Measured: Patients' weight loss in each group will be evaluated and compared 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2022
  2. Study start18 Oct 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Sample size was calculated to detect a ≥5 kg preoperative weight loss in 55% of patients in the intervention group versus 39% in the control group, allowing for 16% attrition, with 95% confidence and 80% power
Masking
None (open label)
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05598840
Sponsor's protocol ID
HUB-VAMOS
Acronym
VAMOS
Status last verified
Mar 2026
First submitted
23 Sep 2022
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery. and Very low calory diet in people with Morbid Obesity and Weight Loss, run by Hospital Universitari de Bellvitge at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative weight loss (time frame: App will be provided four months before surgery and then preoperative weight loss achieved will be evaluated the day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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