Bariatric SurgeryNCT05278767
The Effects of E-Mobile Education and Counselling Services on Bariatric Surgery Patients
A study testing E-Mobile Education and Counselling in people with Bariatric Surgery and Counselling, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled trial to determine the effects of e-mobile education and counselling service on self-care agency, body image, and quality of life in patients undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Counselling, Patient Education
- What is being tested?
- E-Mobile Education and Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2020to 10 Jan 2022
- 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
- Being literate,
- Being able to understand and speak Turkish
- First time bariatric surgery,
- Having undergone sleeve gastrectomy or gastric bypass operation with laparoscopic method,
- Ability to use a smart phone,
- Agreeing to participate in the research. exclusion criteria:
Show all 9Show fewer
- Having any psychiatric disorder that will reduce the ability to comprehend and understand,
- Any complications during the surgical intervention,
- Having a speech and hearing disability.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova University Institute of Health Sciences
Adana, 01030
About this study
Official title: The Effects of E-Mobile Education and Counselling Services on Self-Care, Body Image and Quality of Life of Bariatric Surgery Patients
This study was conducted as a randomized controlled trial to determine the effects of e-mobile education and counselling service on self-care agency, body image, and quality of life in patients undergoing bariatric surgery.
The sample of the study was determined using power analysis after making preliminary tests with the patients who met the sample selection criteria in Isparta City Hospital Obesity Center, and consisted of 51 (26 experiment, 25 control) patients. The patients in the experimental group received e-mobile training and consultancy services with the mobile application developed specifically for bariatric surgery that started before the operation and lasted for 3 months. The data of the study were collected using the Personal Information Form, Self-Care Agency, Body Image, and Moorehead Ardelt Quality of Life II (MA-II) Scales prepared in accordance with the literature. In addition to descriptive statistics, Chi-Square, Independent Samples t-test, Repeated Measures, Mann-Whitney U and Friedman tests were used to evaluate the data.
A statistically significant difference was found in the mean scores of Self-Care Strength, Body Image, MA-II and BMI of the patients in the experimental and control groups according to the processes (p>0.05). There was no statistically significant difference between the groups in terms of preoperative, 1st, 2nd, and 3rd month Self-Care Power, Body Image and MA-II scale mean scores (p>0.05). There was a statistically significant difference between the groups in favour of the experimental group in terms of the 1st, 2nd, and 3rd month BMI averages (p<0.05).
Read the detailed description
This research was carried out as a randomized controlled interventional study to determine the effect of e-mobile education and counseling service on self-care power, body image and quality of life in patients undergoing bariatric surgery. The population of the study consisted of patients who underwent bariatric surgery in Isparta City Hospital, Obesity Center between July 2020 and July 2021. The sample consisted of patients who met the sample selection criteria in Isparta City Hospital Obesity Center and agreed to participate in the research verbally and in writing.
Considering that the education and counseling services provided to the patients who met the inclusion criteria of the study and accepted to participate, might affect the effectiveness of the education level, the education level was determined as a criterion, and the patients were divided into the application and control groups using a simple random and stratified randomization method. The first patient included in the study in randomization was determined by the simple randomization method (coin-toss), and when a patient with the same education level came, he was necessarily included in the other group. Thus, the sampled individuals in the research group were divided into strata according to their education level. Five patients were excluded from follow-up due to the fact that one patient (n=1) wanted to withdraw from the study, three patients (n=3) could not be contacted, and one patient (n=1) developed complications. It was completed with 51 patients.The data of the study were collected using the Personal Information Form, Self-Care Strength Scale, Body Image Scale, Moorehead Ardelt Quality of Life Scale II (MA-II) prepared in line with the literature. In addition, the Quality Criteria Questionnaire for Health Information User (DISCERN) was used to evaluate the reliability and quality of the written educational material that will form the content of the mobile application, and the System Usability Scale was used to evaluate the functionality and usability of the mobile application.
The data of the study were carried out with 2 groups as control (standard care) and application (mobile application). Randomization was carried out after meeting the patients who were planned to undergo bariatric surgery, treated in the obesity clinic, who met the sampling criteria and agreed to participate in the study, and were informed about the purpose of the study.
The study was conducted in 4 stages with patients undergoing bariatric surgery.
- Conditions
- Bariatric Surgery, Counselling, Patient Education, Mobile Application
- Being tested
- E-Mobile Education and Counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Mobile Education and CounsellingOther
The patients in the experimental group received e-mobile training and consultancy services with the mobile application developed specifically for bariatric surgery that started before the operation and lasted for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| application group | Experimental | The mobile health application (https://play.google.com/store/apps/details?id=com.sanberk.bariatriksurgery) prepared for patients undergoing bariatric surgery was completed in 6 stages. After the mobile application has been developed, a short (20-minute) brief contains information about the mobile application in the pre-operative polyclinic for the patients who are planned for bariatric surgery. The patient was followed for three months. Data were collected from the patient every month (4 times). Receives: Other: E-Mobile Education and Counselling |
| control group | No intervention | Standard care and follow-up protocols were applied to the patients.The patient was followed for three months. Data were collected from the patient every month (4 times). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Care Agency and E-Mobile Training and Consultancy
One of the main aims of this researchis to evaluate self-care agency satisfaction of the individuals by providing mobile-based training and consultancy services that enable them to easily access the right information at any time and place. In this context, the self-care agency scale was used. For this, individuals were evaluated before the operation, at the 1st, 2nd, and 3rd months after the operation.
Measured: Three months
Body Image and E-Mobile Training and Consultancy
One of the main aims of this researchis to evaluate body image satisfaction of the individuals by providing mobile-based training and consultancy services that enable them to easily access the right information at any time and place. In this context, the body image scale was used. For this, individuals were evaluated before the operation, at the 1st, 2nd, and 3rd months after the operation.
Measured: Three months
Quality of Life and E-Mobile Training and Consultancy
One of the main aims of this researchis to evaluate quality of life satisfaction of the individuals by providing mobile-based training and consultancy services that enable them to easily access the right information at any time and place. In this context, the Moorehead-Ardelt Quality of Life Questionnaire II was used. For this, individuals were evaluated before the operation, at the 1st, 2nd, and 3rd months after the operation.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start25 Feb 2020
- Primary completion25 Jul 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Deniz Dogan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278767
- Sponsor's protocol ID
- 5312256939
- Status last verified
- Mar 2022
- First submitted
- 10 Jan 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deniz Dogan S, Arslan S. The Effects of e-Mobile Training and Consultancy Services on Bariatric Surgery Patients: A Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3650-3657. doi: 10.1007/s11695-022-06255-x. Epub 2022 Sep 1.
PubMed 36045256
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of E-Mobile Education and Counselling Services on Self-Care, Body Image and Quality of Life of Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT05278767
- Acronym / sponsor ID
- 5312256939
- Conditions
- Bariatric Surgery, Counselling, Patient Education, Mobile Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 14 Mar 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.
This study was conducted as a randomized controlled trial to determine the effects of e-mobile education and counselling service on self-care agency, body image, and quality of life in patients undergoing bariatric surgery.
The sample of the study was determined using power analysis after making preliminary tests with the patients who met the sample selection criteria in Isparta City Hospital Obesity Center, and consisted of 51 (26 experiment, 25 control) patients. The patients in the experimental group received e-mobile training and consultancy services with the mobile application developed specifically for bariatric surgery that started before the operation and lasted for 3 months. The data of the study were collected using the Personal Information Form, Self-Care Agency, Body Image, and Moorehead Ardelt Quality of Life II (MA-II) Scales prepared in accordance with the literature. In addition to descriptive statistics, Chi-Square, Independent Samples t-test, Repeated Measures, Mann-Whitney U and Friedman tests were used to evaluate the data.
A statistically significant difference was found in the mean scores of Self-Care Strength, Body Image, MA-II and BMI of the patients in the experimental and control groups according to the processes (p>0.05). There was no statistically significant difference between the groups in terms of preoperative, 1st, 2nd, and 3rd month Self-Care Power, Body Image and MA-II scale mean scores (p>0.05). There was a statistically significant difference between the groups in favour of the experimental group in terms of the 1st, 2nd, and 3rd month BMI averages (p<0.05).
Detailed description
This research was carried out as a randomized controlled interventional study to determine the effect of e-mobile education and counseling service on self-care power, body image and quality of life in patients undergoing bariatric surgery. The population of the study consisted of patients who underwent bariatric surgery in Isparta City Hospital, Obesity Center between July 2020 and July 2021. The sample consisted of patients who met the sample selection criteria in Isparta City Hospital Obesity Center and agreed to participate in the research verbally and in writing.
Considering that the education and counseling services provided to the patients who met the inclusion criteria of the study and accepted to participate, might affect the effectiveness of the education level, the education level was determined as a criterion, and the patients were divided into the application and control groups using a simple random and stratified randomization method. The first patient included in the study in randomization was determined by the simple randomization method (coin-toss), and when a patient with the same education level came, he was necessarily included in the other group. Thus, the sampled individuals in the research group were divided into strata according to their education level. Five patients were excluded from follow-up due to the fact that one patient (n=1) wanted to withdraw from the study, three patients (n=3) could not be contacted, and one patient (n=1) developed complications. It was completed with 51 patients.The data of the study were collected using the Personal Information Form, Self-Care Strength Scale, Body Image Scale, Moorehead Ardelt Quality of Life Scale II (MA-II) prepared in line with the literature. In addition, the Quality Criteria Questionnaire for Health Information User (DISCERN) was used to evaluate the reliability and quality of the written educational material that will form the content of the mobile application, and the System Usability Scale was used to evaluate the functionality and usability of the mobile application.
The data of the study were carried out with 2 groups as control (standard care) and application (mobile application). Randomization was carried out after meeting the patients who were planned to undergo bariatric surgery, treated in the obesity clinic, who met the sampling criteria and agreed to participate in the study, and were informed about the purpose of the study.
The study was conducted in 4 stages with patients undergoing bariatric surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| application group | Experimental | Other: E-Mobile Education and CounsellingThe mobile health application (https://play.google.com/store/apps/details?id=com.sanberk.bariatriksurgery) prepared for patients undergoing bariatric surgery was completed in 6 stages. After the mobile application has been developed, a short (20-minute) brief contains information about the mobile application in the pre-operative polyclinic for the patients who are planned for bariatric surgery. The patient was followed for three months. Data were collected from the patient every month (4 times). |
| control group | No intervention | –Standard care and follow-up protocols were applied to the patients.The patient was followed for three months. Data were collected from the patient every month (4 times). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being literate,
- Being able to understand and speak Turkish
- First time bariatric surgery,
- Having undergone sleeve gastrectomy or gastric bypass operation with laparoscopic method,
- Ability to use a smart phone,
Key exclusion criteria (0 listed)
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-Mobile Education and CounsellingThe patients in the experimental group received e-mobile training and consultancy services with the mobile application developed specifically for bariatric surgery that started before the operation and lasted for 3 months. | Other | application group |
Primary outcome
Self Care Agency and E-Mobile Training and Consultancy
Time frame: Three months
One of the main aims of this researchis to evaluate self-care agency satisfaction of the individuals by providing mobile-based training and consultancy services that enable them to easily access the right information at any time and place. In this context, the self-care agency scale was used. For this, individuals were evaluated before the operation, at the 1st, 2nd, and 3rd months after the operation.
Body Image and E-Mobile Training and Consultancy
Time frame: Three months
One of the main aims of this researchis to evaluate body image satisfaction of the individuals by providing mobile-based training and consultancy services that enable them to easily access the right information at any time and place. In this context, the body image scale was used. For this, individuals were evaluated before the operation, at the 1st, 2nd, and 3rd months after the operation.
Quality of Life and E-Mobile Training and Consultancy
Time frame: Three months
One of the main aims of this researchis to evaluate quality of life satisfaction of the individuals by providing mobile-based training and consultancy services that enable them to easily access the right information at any time and place. In this context, the Moorehead-Ardelt Quality of Life Questionnaire II was used. For this, individuals were evaluated before the operation, at the 1st, 2nd, and 3rd months after the operation.
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 14 Mar 2022.
- Derived from this study: PubMed 36045256Deniz Dogan S, Arslan S. The Effects of e-Mobile Training and Consultancy Services on Bariatric Surgery Patients: A Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3650-3657. doi: 10.1007/s11695-022-06255-x. Epub 2022 Sep 1.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Mobile Education and Counselling in people with Bariatric Surgery and Counselling, run by Cukurova University at 1 site 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 9 inclusion and 0 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 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Care Agency and E-Mobile Training and Consultancy (time frame: Three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05278767, which also lists 1 linked publication.
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 14 Mar 2022.