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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451499
• Other study ID #: 0018-20-ASMC
• Status: Recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: March 2023

Study information

• Verified date: January 2021
• Source: Assuta Medical Center
• Contact: Yafit Kessler, MSc
• Phone: 0097250691645
• Email: yafitke[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Metabolic Diseases
• Nutritional and Metabolic Diseases

Intervention

Other:
• Smartphone app
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.

Locations

Country	Name	City	State
Israel	Assuta Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Assuta Medical Center	Ariel University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in weight	Weight loss	Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Changes in step count	Physical activity will be measured by pedometers	Baseline and up to 3 months (end of the intervention phase)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Surgical time	Surgery time in minutes	During surgery
Secondary	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