Study protocol for a non-inferiority, multicenter, randomized study to evaluate a smartphone app-based follow-up...

Area of Science:

• Bariatric Surgery Outcomes
• Digital Health Interventions
• Remote Patient Monitoring

Background:

• Poor adherence to follow-up (FU) care post-bariatric surgery is a significant challenge.
• Previous pilot studies indicated feasibility and safety of remote FU via smartphone.
• A need exists to validate remote FU in a larger, controlled setting.

Purpose of the Study:

• To verify the efficacy and safety of a remote, smartphone-based follow-up program for bariatric surgery patients.
• To compare a mobile application-based FU program against standard in-person FU care.
• To assess the impact of digital health on post-bariatric surgery outcomes.

Main Methods:

• A multicenter, randomized controlled trial involving 410 participants undergoing primary bariatric surgery.
• Randomization into two groups: standard in-person FU versus smartphone app-based remote FU.
• The app facilitated questionnaires, reminders for supplements/exercise, and remote communication with healthcare professionals.

Main Results:

• The primary outcome is weight loss at 12 months post-surgery.
• Secondary outcomes include obesity-related comorbidities, quality of life, and serum nutrient levels.
• Evaluation of emergency visits, readmissions, patient compliance, and staff workload.

Conclusions:

• This is the first prospective, randomized controlled trial comparing a fully remote, app-based FU program to traditional in-person visits post-bariatric surgery.
• The study aims to establish the mobile application as a viable replacement for conventional follow-up care.
• Findings will inform the integration of digital health solutions in bariatric surgery aftercare.