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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bariatric Surgery Candidate, Nutritional and Metabolic Diseases

Intervention / Treatment
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* Other: Smartphone app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group -smartphone app<br>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<br>* 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.<br>|
| No Intervention: Control group<br>All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight | Weight loss | Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery | 
| Changes in body composition | Body composition will be measured using multi-frequency bioelectrical impedance analysis | Baseline and up to 3 months (end of the intervention phase) | 
| Changes in functionality | Handgrip muscle strength-test will be measured by a digital hand dynamometer | Baseline and up to 3 months (end of the intervention phase) | 
| Changes in hydration state | Patients will be asked to match the color that best describes their urine color according to a standardized urine color scale | Baseline and up to 3 months (end of the intervention phase) | 
| Changes in step count | Physical activity will be measured by pedometers | Baseline and up to 3 months (end of the intervention phase) | 
| Changes in compliance to dietary and lifestyle bariatric surgery recommendations | Patients will be asked if they kept the recommended behaviors by a questionnaire | Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery | 
| Changes in quality of life: VAS scale | Patients will be asked to rate their overall state of health from 0-100 using a VAS scale | Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery | 
| Readiness for surgery | Patients will be asked to rate their subjectively overall readiness to the surgery from 0-100 using a VAS scale | Up to 3 months (end of the intervention phase) | 
| The subject's experience regarding the smartphone app | Patients in the intervention arm will be ask about the ease of use | Up to 3 months (end of the intervention phase) | 
| Surgical time | Surgery time in minutes | During surgery | 
| Adherence to post-surgical follow-up by the bariatric team | Patients will be ask how many meetings they had with the bariatric team since the surgery | 1 and 2 years post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, Nutrition, Smartphone-based education platform, Pre-surgery preparation