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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Morbid Obesity, Weight Loss
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery.; Behavioral: Very low calory diet |
| 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. Receives: Behavioral: Very low calory diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted28 Oct 2022
- Study start18 Oct 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Osorio, Hospital Universitari de Bellvitge
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05598840
- Acronym / sponsor ID
- VAMOS / HUB-VAMOS
- Conditions
- Morbid Obesity, Weight Loss
- Keywords
- Mobile APP, Obesity, R-en-Y gastric bypass, Preoperative weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| APP group | Experimental | Behavioral: Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery., Behavioral: Very low calory dietFour months before surgery, the C4T APP, in addition to standard protocol, will be provided to all the patients randomized in the APP group. |
| Normal VLCD (Very Low Calory Diet) group | Active comparator | Behavioral: Very low calory dietNormal preoperative standard protocol will be provided to all the patients randomized in the normal group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care4Today APP: multimodal digital prehabilitation programme for candidates undergoing bariatric surgery.Multimodal digital prehabilitation programme for candidates undergoing bariatric surgery. | Behavioural | APP group |
| Very low calory dietStandard follow-up with very-low calory diet | Behavioural | APP group, Normal VLCD (Very Low Calory Diet) group |
Primary outcome
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
To compare patients' preoperative weight loss after using the C4T APP versus the standard preoperative protocol.
4 secondary outcomes
patient information using the APP
Time frame: App will be provided four months before surgery and patients' information/satisfaction using the APP will be evaluated the day of surgery
patient satisfaction using the APP
Time frame: 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 complications
Time frame: Early complication rate in each group will be evaluated and compared 30 and 90 days postoperative
Correlation between preoperative weight loss and Early postoperative weight loss
Time frame: Patients' weight loss in each group will be evaluated and compared 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.