- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yafit Kessler, MSc
- Phone Number: 0097250691645
- Email: yafitke@gmail.com
Study Locations
-
-
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Tel Aviv, Israel
- Recruiting
- Assuta Medical Center
-
Contact:
- Shiri Sherf-Dagan, PhD
- Phone Number: +972-525122203
- Email: shirishe@assuta.co.il
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group -smartphone app
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. |
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.
|
No Intervention: Control group
All the participants will receive the standard care of 3-6 preparation to bariatric surgery meetings with a dietitian.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and up to 3 months (end of the intervention phase)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in weight
Time Frame: Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
|
Weight loss
|
Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
|
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
|
Baseline and up to 3 months (end of the intervention phase)
|
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
|
Baseline and up to 3 months (end of the intervention phase)
|
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
|
Baseline and up to 3 months (end of the intervention phase)
|
Changes in step count
Time Frame: Baseline and up to 3 months (end of the intervention phase)
|
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
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
|
Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
|
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
|
Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
|
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
|
Up to 3 months (end of the intervention phase)
|
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
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Up to 3 months (end of the intervention phase)
|
Surgical time
Time Frame: During surgery
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Surgery time in minutes
|
During surgery
|
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
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1 and 2 years post-surgery
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0018-20-ASMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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