NCT06163235

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
21mo left

Started Sep 2025

Typical duration for not_applicable obesity

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

November 20, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

November 20, 2023

Last Update Submit

August 17, 2025

Conditions

ObesityBariatric Surgery Candidate

Keywords

Bariatric surgeryTelemedicineWeight loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    The percentage of total weight loss at 12 months after bariatric surgery.

    1 year

Secondary Outcomes (6)

  • Medical-surgical complications.

    1 year

  • Diet quality.

    1 year

  • Degree of physical activity.

    1 year

  • Degree of satisfaction and quality of life.

    1 year

  • Loss to follow-up.

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Semi-attendance.

EXPERIMENTAL

This group will follow a semi-attendance program after bariatric surgery.

Other: Obemar platform

Control group.

NO INTERVENTION

This group will follow the conventional controls after bariatric surgery.

Interventions

Obemar platformOTHER

Online platform for education and follow-up

Semi-attendance.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 35-50kg/m2
  • Bariatric surgery candidates

You may not qualify if:

  • Non-controlled psychiatric disorder
  • Pregnancy desire in the next 12 months
  • Do not have mobile devices (smartphone)
  • Language barrier with Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Anna Casajoana, PhD

    Hospital del Mar Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Morera-Grau, MD

CONTACT

+34676360172alexmoreragrau@gmail.com

Anna Casajoana, PhD

CONTACT

+34676610741acasajoanabadia@psmar.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 8, 2023

Study Start

September 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share