ObesityNCT05428618
Mobile Application for Bariatric Surgery Patients
A study testing e-BariS app group and Self-Monitoring Group in people with Obesity and Bariatric Surgery, run by Akdeniz University at 2 sites in Turkey (Türkiye).
Trial summary
Introduction: One of the alternative ways, as a result of the increasing demand for health services and the inadequacy of meeting the increasing needs, is mobile health applications. According to TUIK 2019 data, the rate of having mobile phones in households is 98.7%. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bariatric Surgery, Quality of Life
- What is being tested?
- e-BariS app group and Self-Monitoring Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speaking and understanding Turkish,
- Being literate
- Having the ability to use a smartphone,
- Having a mobile phone with IOS or Android software,
- Having internet access,
- Having consented to download the mobile application to the mobile phone,
- Between the ages of 18-65,
- Patients undergoing bariatric surgery for the first time.
Who cannot join
- Patients with vision or hearing problems
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Effect of Mobile Support Application Developed for Patients Undergoing Bariatric Surgery on Self-Management, Quality of Life and Clinical Outcomes
Introduction: One of the alternative ways, as a result of the increasing demand for health services and the inadequacy of meeting the increasing needs, is mobile health applications. According to TUIK 2019 data, the rate of having mobile phones in households is 98.7%. With the development of technology, all information can be integrated into the mobile phone, and mobile applications allow the patient to give data from the environment in which he lives and to evaluate himself. Self-assessment and monitoring of the patient enable the patient to participate in his/her self-care, supports self-management behaviors, and improves their quality of life.
Objective: It was aimed to develop a mobile support application for patients undergoing bariatric surgery and to evaluate the effect of application use on patients' self-management, quality of life, and clinical outcomes.
Read more
Method: In the first stage;
- Preparing the information to be included in the mobile health application that is planned to be developed and evaluating the quality of the content,
- Parallel to this, the adaptation of the "Bariatric Surgery Self-Management Behaviors Scale" into Turkish and the evaluation of its validity and reliability.
- Design of the mobile application, transferring the educational content to the mobile application,
- It is aimed to evaluate the technical suitability and usability of the mobile application.
In the second stage, it was aimed to conduct a randomized controlled study to determine the effect of the developed mobile application on the self-management, quality of life and clinical outcomes of the patients.
The developed mobile application will be introduced to patients at discharge after bariatric surgery. Rating scales will be administered to patients at the end of one, three, and six months after surgery. These scales are the Bariatric Surgery Self-Management Behaviors Scale and the Moorehead-Ardelt Quality of Life Scale-II.
Conclusion: It is expected that the mobile application-based education to be developed for bariatric surgery will improve the patients' post-surgical self-management, increase their quality of life and decrease the early complication rates.
- Conditions
- Obesity, Bariatric Surgery, Quality of Life, Complication, Mobile Health, EHealth
- Being tested
- e-BariS app group, Self-Monitoring Group
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-BariS app groupOther
During the discharge process, informed consent will be obtained from the patients and the measurement tools will be filled and the mobile application will be downloaded to their phones. The intervention group will have access to all the content of the mobile application, which includes the "Self-Monitoring Module" and the "Patient Education Module". Passwords will be defined so that patients in the intervention group can access the "Patient Education Module". Information on the introduction and use of the application will be presented to the patient by the researcher.
The patients will be followed for six months within the scope of the project. In addition, reminder notifications will be sent to patients via the mobile application in line with the areas that patients can access. At one, three, and six months after surgery, he will complete other assessment scales during outpatient follow-up. For patients providing remote control, the scale will be sent online.
Self-Monitoring GroupOther
Patients in the control group will only have access to the "Self-Monitoring Module" in the application. Other fields will be encrypted. Patients in the control group will also be informed about the area they can access. Patients in the control group will only have access to the self-monitoring section. One, three, and six months after surgery, she will complete other assessment scales during her outpatient follow-up. Scales will be sent online for patients providing remote control. After the project is completed, all content will be opened to the control group patients.
| Study group | Role | What they receive |
|---|---|---|
| e-BariS app Group | Experimental | "Self-Monitoring Module" and "Patient Education Module" Receives: Other: e-BariS app group |
| Self-Monitoring Group | Sham comparator | "Self-Monitoring Module" Receives: Other: Self-Monitoring Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Management
The self-management scores of the patients will be measured with the Bariatric Surgery Self-Management Behaviors Scale.
The scale was developed by Welch and colleagues in 2008. Validity and reliability were done in Iran in 2018.
It consists of seven factors and 33 items, including eating behaviors (8), fluid intake (8), physical activity (3), dumping syndrome management (4), vitamin and mineral supplement (4), fruit, vegetable, and cereals (3), protein intake (3). It is evaluated with a triple Likert scale as never, sometimes, and always. Subscale and total scores were converted to the range of 0-100, higher scores indicate higher self-management.
Measured: Change from baseline BBSQ at one month, Change from baseline BBSQ at 3 months, Change from baseline BBSQ at 6 months
Quality of Life Scale
The Moorehead-Ardelt Quality of Life Scale (MA-II) was developed in 1998. The scale consists of six questions including self-esteem, physical function, social relations, ability to work, sexuality, and eating behavior. At the same time, each item of the scale is supported by figures related to the subject in order to help individuals from different cultures understand. Each item has a 10-point Likert-type measure. Each item is equally weighted and increases and decreases by 0.10 points positively and negatively, keeping the 0 value in the center. While each item decreases by 0.10 points from the "0" point to the left, it increases by 0.10 points to the right. The scores for each item range from -0.50 to 0.50. The total scale scoring varies between -3 and +3, the score between -2.1 and -3 is considered a very poor quality of life, and between +2.1 and +3, the quality of life is considered.
Measured: Change from baseline MA-II at one month, Change from baseline MA-II at 3 months, Change from baseline MA-II at 6 months
Secondary outcomes (10)
Weight loss
Official measurements made by the hospital Measurements will be made in kg
Measured: Change from baseline kilogram for weight loss at one month, Change from baseline kilogram for weight loss at 3 months, Change from baseline kilogram for weight loss at 6 months
Nausea
Nausea after eating will be questioned in the evaluation of dumping syndrome. Nausea will be evaluated with a self-reported scale the Visual Analog Scale. The scale ranges from 1 to 10. In the measurement, 1 = I have no nausea, 10 = I have unbearable nausea.
Measured: Change from baseline Visual Analog Scale (VAS) for nausea at one month, Change from one month VAS for nausea at 3 months, Change from 3 months VAS for nausea at 6 months
Vomiting
Vomiting after eating will be questioned in the evaluation of dumping syndrome. Vomiting will be evaluated with a self-reported scale the Visual Analog Scale. The scale ranges from 1 to 10. In the measurement, 1 = I have no vomiting, 10 = I have unbearable vomiting.
Measured: Change from baseline Visual Analog Scale (VAS) for vomiting at one month, Change from one month VAS for vomiting at 3 months, Change from 3 months VAS for vomiting at 6 months
Dizziness
Dizziness after eating will be questioned in the evaluation of dumping syndrome.
Dizziness will be evaluated with a self-reported scale the Visual Analog Scale. The scale ranges from 1 to 10. In the measurement, 1 = I have no dizziness, 10 = I have unbearable dizziness.
Measured: Change from baseline Visual Analog Scale (VAS) for dizziness at one month, Change from one month VAS for dizziness at 3 months, Change from 3 months VAS for dizziness at 6 months
Pain-Visual Analog Scale
Pain will be evaluated with a self-reported scale the Visual Analog Scale. The scale ranges from 1 to 10. In the measurement, 1 = I have no pain, 10 = I have unbearable pain.
Measured: Change from baseline Visual Analog Scale (VAS) for pain at one month, Change from one month VAS for pain at 3 months, Change from 3 months VAS for pain at 6 months
wound infection
Wound infection will be evaluated with a self-reported scale the Visual Analog Scale. The scale ranges from 1 to 10. In the measurement, 1 = I have no wound infection, 10 = I have an unbearable wound infection.
Measured: Change from baseline Visual Analog Scale (VAS) for wound infection at one month.
Hypoglycemia
Hypoglycemia will be evaluated with a self-reported scale the Visual Analog Scale. The scale ranges from 1 to 10. In the measurement, 1 = I have no hypoglycemia, 10 = I have unbearable hypoglycemia.
Measured: Change from baseline Visual Analog Scale (VAS) for hypoglycemia at one month, Change from one month VAS for hypoglycemia at 3 months, Change from 3 months VAS for hypoglycemia at 6 months.
Constipation
Constipation will be evaluated with a self-reported scale the Visual Analog Scale. The scale ranges from 1 to 10. In the measurement, 1 = I have no constipation, 10 = I have unbearable constipation.
Measured: Change from baseline Visual Analog Scale (VAS)for constipation at one month, Change from one month VAS for constipation at 3 months, Change from 3 months VAS for constipation at 6 months.
Number of emergency admissions
A number of emergency admissions will be evaluated with a self-reported. How many times the patient applied to the emergency department will be evaluated by asking open-ended questions.
Measured: Change from baseline Number of emergency admissions at one month, Change from one month number of emergency admissions at 3 months, Change from 3 months number of emergency admissions at 6 months.
Number of hospital readmission
A number of hospital readmission will be evaluated with a self-reported. How many times the patient applied to the emergency department will be evaluated by asking open-ended questions.
Measured: Change from baseline number of hospital readmission at one month, Change from one month number of hospital readmission at 3 months, Change from 3 months number of hospital readmission at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Antalya Training and Research Hospital
- Responsible party
- Principal investigator, Damla Seckin, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428618
- Sponsor's protocol ID
- w34dsxfh
- Status last verified
- Sep 2023
- First submitted
- 10 Feb 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Support Application Developed for Patients Undergoing Bariatric Surgery on Self-Management, Quality of Life and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT05428618
- Acronym / sponsor ID
- w34dsxfh
- Conditions
- Obesity, Bariatric Surgery, Quality of Life, Complication, Mobile Health, EHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Antalya Training and Research Hospital
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: One of the alternative ways, as a result of the increasing demand for health services and the inadequacy of meeting the increasing needs, is mobile health applications. According to TUIK 2019 data, the rate of having mobile phones in households is 98.7%. With the development of technology, all information can be integrated into the mobile phone, and mobile applications allow the patient to give data from the environment in which he lives and to evaluate himself. Self-assessment and monitoring of the patient enable the patient to participate in his/her self-care, supports self-management behaviors, and improves their quality of life.
Objective: It was aimed to develop a mobile support application for patients undergoing bariatric surgery and to evaluate the effect of application use on patients' self-management, quality of life, and clinical outcomes.
Method: In the first stage;
- Preparing the information to be included in the mobile health application that is planned to be developed and evaluating the quality of the content,
- Parallel to this, the adaptation of the "Bariatric Surgery Self-Management Behaviors Scale" into Turkish and the evaluation of its validity and reliability.
- Design of the mobile application, transferring the educational content to the mobile application,
- It is aimed to evaluate the technical suitability and usability of the mobile application.
In the second stage, it was aimed to conduct a randomized controlled study to determine the effect of the developed mobile application on the self-management, quality of life and clinical outcomes of the patients.
The developed mobile application will be introduced to patients at discharge after bariatric surgery. Rating scales will be administered to patients at the end of one, three, and six months after surgery. These scales are the Bariatric Surgery Self-Management Behaviors Scale and the Moorehead-Ardelt Quality of Life Scale-II.
Conclusion: It is expected that the mobile application-based education to be developed for bariatric surgery will improve the patients' post-surgical self-management, increase their quality of life and decrease the early complication rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-BariS app Group | Experimental | Other: e-BariS app group"Self-Monitoring Module" and "Patient Education Module" |
| Self-Monitoring Group | Sham comparator | Other: Self-Monitoring Group"Self-Monitoring Module" |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Speaking and understanding Turkish,
- Being literate
- Having the ability to use a smartphone,
- Having a mobile phone with IOS or Android software,
- Having internet access,
Key exclusion criteria (1 listed)
- Patients with vision or hearing problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-BariS app groupDuring the discharge process, informed consent will be obtained from the patients and the measurement tools will be filled and the mobile application will be downloaded to their phones. The intervention group will have access to all the content of the mobile application, which includes the "Self-Monitoring Module" and the "Patient Education Module". Passwords will be defined so that patients in the intervention group can access the "Patient Education Module". Information on the introduction and use of the application will be presented to the patient by the researcher. The patients will be followed for six months within the scope of the project. In addition, reminder notifications will be sent to patients via the mobile application in line with the areas that patients can access. At one, three, and six months after surgery, he will complete other assessment scales during outpatient follow-up. For patients providing remote control, the scale will be sent online. | Other | e-BariS app Group |
| Self-Monitoring GroupPatients in the control group will only have access to the "Self-Monitoring Module" in the application. Other fields will be encrypted. Patients in the control group will also be informed about the area they can access. Patients in the control group will only have access to the self-monitoring section. One, three, and six months after surgery, she will complete other assessment scales during her outpatient follow-up. Scales will be sent online for patients providing remote control. After the project is completed, all content will be opened to the control group patients. | Other | Self-Monitoring Group |
Primary outcome
Self-Management
Time frame: Change from baseline BBSQ at one month, Change from baseline BBSQ at 3 months, Change from baseline BBSQ at 6 months
The self-management scores of the patients will be measured with the Bariatric Surgery Self-Management Behaviors Scale. The scale was developed by Welch and colleagues in 2008. Validity and reliability were done in Iran in 2018. It consists of seven factors and 33 items, including eating behaviors (8), fluid intake (8), physical activity (3), dumping syndrome management (4), vitamin and mineral supplement (4), fruit, vegetable, and cereals (3), protein intake (3). It is evaluated with a triple Likert scale as never, sometimes, and always. Subscale and total scores were converted to the range of 0-100, higher scores indicate higher self-management.
Quality of Life Scale
Time frame: Change from baseline MA-II at one month, Change from baseline MA-II at 3 months, Change from baseline MA-II at 6 months
The Moorehead-Ardelt Quality of Life Scale (MA-II) was developed in 1998. The scale consists of six questions including self-esteem, physical function, social relations, ability to work, sexuality, and eating behavior. At the same time, each item of the scale is supported by figures related to the subject in order to help individuals from different cultures understand. Each item has a 10-point Likert-type measure. Each item is equally weighted and increases and decreases by 0.10 points positively and negatively, keeping the 0 value in the center. While each item decreases by 0.10 points from the "0" point to the left, it increases by 0.10 points to the right. The scores for each item range from -0.50 to 0.50. The total scale scoring varies between -3 and +3, the score between -2.1 and -3 is considered a very poor quality of life, and between +2.1 and +3, the quality of life is considered.
10 secondary outcomes
Weight loss
Time frame: Change from baseline kilogram for weight loss at one month, Change from baseline kilogram for weight loss at 3 months, Change from baseline kilogram for weight loss at 6 months
Nausea
Time frame: Change from baseline Visual Analog Scale (VAS) for nausea at one month, Change from one month VAS for nausea at 3 months, Change from 3 months VAS for nausea at 6 months
Vomiting
Time frame: Change from baseline Visual Analog Scale (VAS) for vomiting at one month, Change from one month VAS for vomiting at 3 months, Change from 3 months VAS for vomiting at 6 months
Dizziness
Time frame: Change from baseline Visual Analog Scale (VAS) for dizziness at one month, Change from one month VAS for dizziness at 3 months, Change from 3 months VAS for dizziness at 6 months
Pain-Visual Analog Scale
Time frame: Change from baseline Visual Analog Scale (VAS) for pain at one month, Change from one month VAS for pain at 3 months, Change from 3 months VAS for pain at 6 months
wound infection
Time frame: Change from baseline Visual Analog Scale (VAS) for wound infection at one month.
Hypoglycemia
Time frame: Change from baseline Visual Analog Scale (VAS) for hypoglycemia at one month, Change from one month VAS for hypoglycemia at 3 months, Change from 3 months VAS for hypoglycemia at 6 months.
Constipation
Time frame: Change from baseline Visual Analog Scale (VAS)for constipation at one month, Change from one month VAS for constipation at 3 months, Change from 3 months VAS for constipation at 6 months.
Number of emergency admissions
Time frame: Change from baseline Number of emergency admissions at one month, Change from one month number of emergency admissions at 3 months, Change from 3 months number of emergency admissions at 6 months.
Number of hospital readmission
Time frame: Change from baseline number of hospital readmission at one month, Change from one month number of hospital readmission at 3 months, Change from 3 months number of hospital readmission at 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-BariS app group and Self-Monitoring Group in people with Obesity and Bariatric Surgery, run by Akdeniz University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Management (time frame: Change from baseline BBSQ at one month, Change from baseline BBSQ at 3 months, Change from baseline BBSQ at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.