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

NCT05598840 | Completed

• 1 other identifier: HUB-VAMOS
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morbid Obesity; Weight Loss

Keywords

Mobile APP; Obesity; R-en-Y gastric bypass; Preoperative weight loss

Outcome Measures

Primary Outcomes (1)

• Preoperative weight loss

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

  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

  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

  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

  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

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

Study Arms (2)

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.

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.

Behavioral: Very low calory diet

Interventions

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

Multimodal digital prehabilitation programme for candidates undergoing bariatric surgery.

APP group

Very low calory diet BEHAVIORAL

Standard follow-up with very-low calory diet

APP group; Normal VLCD (Very Low Calory Diet) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Bariatric and Metabolic surgical Unit

Model Details: 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

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 28, 2022
• Study Start: October 18, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)