NCT06163235Not yet recruiting
Efficacy of a Mobile Application and Semi-attendance Program in Bariatric Surgery
Efficacy of a Mobile Application and Semi-attendance Program in Bariatric Surgery: a Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 20 Nov 2023
- Start date
- 25 Sept 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Parc de Salut Mar
- Diseases
- Obesity
- NCT number
- NCT06163235
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 25 Sept 2025 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Non-controlled psychiatric disorder
Other
- Pregnancy desire in the next 12 months
- Do not have mobile devices (smartphone)
- Language barrier with Spanish.
Who the study is looking for
- BMI between 35-50kg/m2
- Bariatric surgery candidates
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.