NCT04451499

Brief Summary

A randomized controlled trial on 40 bariatric surgery candidates who will be randomized into two arms (app vs. control). All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian, and only those participants who will assigned to the experimental group will get access to our study's smartphone app site during this period. Evaluations will be performed at baseline, at the end of the intervention phase (after 3-6 meetings as needed) and at 1 and 2 years post-surgery (data will be collected at 1 and 2 years post-surgery by phone calls). Data which will be collected for this study include:demographics and medical data, anthropometrics including body composition analysis, handgrip Strength, physical activity, hydration state, bariatric surgery knowledge questionnaire, quality of life by visual analogue scale, compliance to dietary and lifestyle BS recommendations, readiness for surgery, the subject's experience regarding the smartphone app, surgical data and adherence to post-surgical follow-up by the bariatric team.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 28, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2023

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

June 23, 2020

Last Update Submit

December 23, 2025

Conditions

Nutritional and Metabolic DiseasesBariatric Surgery Candidate

Keywords

Bariatric surgeryNutritionSmartphone-based education platformPre-surgery preparation

Outcome Measures

Primary Outcomes (1)

  • Changes in bariatric surgery nutrition-knowledge score

    Bariatric surgery nutrition-knowledge score will be measured by a validated questionnaire

    Baseline and up to 3 months (end of the intervention phase)

Secondary Outcomes (11)

  • Changes in weight

    Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery

  • Changes in body composition

    Baseline and up to 3 months (end of the intervention phase)

  • Changes in functionality

    Baseline and up to 3 months (end of the intervention phase)

  • Changes in hydration state

    Baseline and up to 3 months (end of the intervention phase)

  • Changes in step count

    Baseline and up to 3 months (end of the intervention phase)

  • +6 more secondary outcomes

Study Arms (2)

Intervention group -smartphone app

EXPERIMENTAL

All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian. All the participants will get access to our study's smartphone app site.

Other: Smartphone app

Control group

NO INTERVENTION

All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian.

Interventions

Smartphone appOTHER

The study specific smartphone app site will be based on current literature plus investigators experience and will include a wide knowledge on types of surgeries, dietary guidelines pre- and post-surgery, fluids type and amount, knowledge on supplementation use pre and post-surgery, general dietary knowledge, psychological information, physical activity, recommendation and tips for long-term surgery success, emphasis will be made on long-term follow-up meetings with the bariatric team and practical information on the preparation to the hospitalization process. The smartphone app site will contain video-based modules and encouraging messages. Patients will be encouraged to use the platform to ask questions and receive answers regarding any aspect of the surgery.

Intervention group -smartphone app

Eligibility Criteria

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

You may qualify if:

  • Pre-surgery: 18 years old or older, BMI ≥ 40 kg/m² or BMI≥35 kg/m² with comorbidities.
  • Planned surgery types: LSG, RYGB and OAGB
  • Reading and speaking Hebrew.

You may not qualify if:

  • Previous bariatric surgery.
  • Planned surgery types: LAGB or BPD-DS.
  • Patients who underwent more than 1 preparation to bariatric surgery meeting with a dietitian.
  • Patients with an active psychiatric disorder (uncontrolled) or have other contraindications to bariatric surgery such as addiction to alcohol or drugs.
  • Diabetic patients taking Insulin.
  • Patients who do not own a smartphone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Nutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dietitian and Epidemiologist

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 30, 2020

Study Start

December 28, 2020

Primary Completion

October 1, 2022

Study Completion

February 23, 2023

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)