Assuta Medical Center
Tel Aviv, Israel
NCT Number: NCT04451499
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tel Aviv, Israel
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Baseline, up to 3 months (end of the intervention phase) and 1 and 2 years post-surgery
Weight loss
Time frame: Baseline and up to 3 months (end of the intervention phase)
Body composition will be measured using multi-frequency bioelectrical impedance analysis
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
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
Time frame: Baseline and up to 3 months (end of the intervention phase)
Physical activity will be measured by pedometers
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
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
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
Time frame: Up to 3 months (end of the intervention phase)
Patients in the intervention arm will be ask about the ease of use
Time frame: During surgery
Surgery time in minutes
Time frame: 1 and 2 years post-surgery
Patients will be ask how many meetings they had with the bariatric team since the surgery
Assuta Medical Center
Other
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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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