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

Primary Purpose

Bariatric Surgery Candidate, Nutritional and Metabolic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Smartphone app
Sponsored by
Assuta Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bariatric Surgery Candidate focused on measuring Bariatric surgery, Nutrition, Smartphone-based education platform, Pre-surgery preparation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assuta Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group -smartphone app

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in weight
Weight loss
Changes in body composition
Body composition will be measured using multi-frequency bioelectrical impedance analysis
Changes in functionality
Handgrip muscle strength-test will be measured by a digital hand dynamometer
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
Changes in step count
Physical activity will be measured by pedometers
Changes in compliance to dietary and lifestyle bariatric surgery recommendations
Patients will be asked if they kept the recommended behaviors by a questionnaire
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
Readiness for surgery
Patients will be asked to rate their subjectively overall readiness to the surgery from 0-100 using a VAS scale
The subject's experience regarding the smartphone app
Patients in the intervention arm will be ask about the ease of use
Surgical time
Surgery time in minutes
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

Full Information

First Posted
June 23, 2020
Last Updated
January 11, 2021
Sponsor
Assuta Medical Center
Collaborators
Ariel University
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1. Study Identification

Unique Protocol Identification Number
NCT04451499
Brief Title
The Effect of Adding Smartphone-based Platform to the Bariatric Surgery Preparation Process
Official Title
The Effect of Adding Smartphone-based Platform to the Bariatric Surgery Preparation Process
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Medical Center
Collaborators
Ariel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Nutritional and Metabolic Diseases
Keywords
Bariatric surgery, Nutrition, Smartphone-based education platform, Pre-surgery preparation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group -smartphone app
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian.
Intervention Type
Other
Intervention Name(s)
Smartphone app
Intervention Description
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 Outcome Measure Information:
Title
Changes in bariatric surgery nutrition-knowledge score
Description
Bariatric surgery nutrition-knowledge score will be measured by a validated questionnaire
Time Frame
Baseline and up to 3 months (end of the intervention phase)
Secondary Outcome Measure Information:
Title
Changes in weight
Description
Weight loss
Time Frame
Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
Title
Changes in body composition
Description
Body composition will be measured using multi-frequency bioelectrical impedance analysis
Time Frame
Baseline and up to 3 months (end of the intervention phase)
Title
Changes in functionality
Description
Handgrip muscle strength-test will be measured by a digital hand dynamometer
Time Frame
Baseline and up to 3 months (end of the intervention phase)
Title
Changes in hydration state
Description
Patients will be asked to match the color that best describes their urine color according to a standardized urine color scale
Time Frame
Baseline and up to 3 months (end of the intervention phase)
Title
Changes in step count
Description
Physical activity will be measured by pedometers
Time Frame
Baseline and up to 3 months (end of the intervention phase)
Title
Changes in compliance to dietary and lifestyle bariatric surgery recommendations
Description
Patients will be asked if they kept the recommended behaviors by a questionnaire
Time Frame
Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
Title
Changes in quality of life: VAS scale
Description
Patients will be asked to rate their overall state of health from 0-100 using a VAS scale
Time Frame
Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
Title
Readiness for surgery
Description
Patients will be asked to rate their subjectively overall readiness to the surgery from 0-100 using a VAS scale
Time Frame
Up to 3 months (end of the intervention phase)
Title
The subject's experience regarding the smartphone app
Description
Patients in the intervention arm will be ask about the ease of use
Time Frame
Up to 3 months (end of the intervention phase)
Title
Surgical time
Description
Surgery time in minutes
Time Frame
During surgery
Title
Adherence to post-surgical follow-up by the bariatric team
Description
Patients will be ask how many meetings they had with the bariatric team since the surgery
Time Frame
1 and 2 years post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yafit Kessler, MSc
Phone
0097250691645
Email
yafitke@gmail.com
Facility Information:
Facility Name
Assuta Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiri Sherf-Dagan, PhD
Phone
+972-525122203
Email
shirishe@assuta.co.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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