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Completed

NCT Number: NCT04451499

The Effect of Adding Smartphone-based Platform to the Bariatric Surgery Preparation Process

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Medical Center

Tel Aviv, Israel

About this study

A randomized controlled trial on 40 bariatric surgery candidates who will be recruited while attending to the bariatric clinics and by advertisement about the study. Patients will be randomized into two arms (app vs. control) using an online software. 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 be assigned to the experimental group will get access to our study's smartphone app site during this period. 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. In addition, patients will be encouraged to use the platform to ask questions and receive answers regarding any aspect of the surgery.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Smartphone app

Other

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.

Primary outcomes

  1. Changes in bariatric surgery nutrition-knowledge score

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

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

Secondary outcomes

  1. Changes in weight

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

    Weight loss

  2. Changes in body composition

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

    Body composition will be measured using multi-frequency bioelectrical impedance analysis

  3. Changes in functionality

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

    Handgrip muscle strength-test will be measured by a digital hand dynamometer

  4. Changes in hydration state

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

    Patients will be asked to match the color that best describes their urine color according to a standardized urine color scale

  5. Changes in step count

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

    Physical activity will be measured by pedometers

  6. Changes in compliance to dietary and lifestyle bariatric surgery recommendations

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

    Patients will be asked if they kept the recommended behaviors by a questionnaire

  7. Changes in quality of life: VAS scale

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

    Patients will be asked to rate their overall state of health from 0-100 using a VAS scale

  8. Readiness for surgery

    Time frame: Up to 3 months (end of the intervention phase)

    Patients will be asked to rate their subjectively overall readiness to the surgery from 0-100 using a VAS scale

  9. The subject's experience regarding the smartphone app

    Time frame: Up to 3 months (end of the intervention phase)

    Patients in the intervention arm will be ask about the ease of use

  10. Surgical time

    Time frame: During surgery

    Surgery time in minutes

  11. Adherence to post-surgical follow-up by the bariatric team

    Time frame: 1 and 2 years post-surgery

    Patients will be ask how many meetings they had with the bariatric team since the surgery

Sponsors and collaborators

Lead sponsor

Assuta Medical Center

Other

Collaborators

  • Ariel University

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 30, 2020
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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