Nursing CariesNCT05428059
The Effect of Mobile Health-Education Application on Healthy Lifestyle Behaviors in Patients Planned for Bariatric Surgery
A study testing mobile education in people with Nursing Caries and Bariatric Surgery Candidate, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Obesity, which is the second leading cause of preventable death in the world, affects all the systems in the body and affects many physiological problems, as well as the mental state, body image and quality of life of the individual. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Bariatric Surgery Candidate, Mobile Education
- What is being tested?
- mobile education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Jul 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being literate,
- Being able to understand, speak Turkish and not have a hearing impairment,
- First time to undergo bariatric surgery,
- Absence of any psychiatric disorder that will reduce the ability to comprehend and understand,
- Ability to use Android-based smartphones,
- Agreeing to participate in the research.
Who cannot join
- Patient's desire to quit the study
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 Effect of Mobile Health-Education Application on Healthy Lifestyle Behaviors in Patients Planned for Bariatric Surgery:A Randomized Controlled Study
Obesity, which is the second leading cause of preventable death in the world, affects all the systems in the body and affects many physiological problems, as well as the mental state, body image and quality of life of the individual. For this reason, obese individuals try various treatment methods in order to get rid of obesity, and in cases where these methods fail, they often prefer bariatric surgery. It is very important that patients who will undergo bariatric surgery can adapt to the anatomical changes in their body and shape their lifestyle accordingly. Otherwise, it is inevitable for patients to face various complications after surgery. After bariatric surgery, a structured training program in the preoperative period is of great importance in order for the patient to adapt to the changes in his body, to prevent the development of possible complications, to be affected by the negativities that may occur due to the current change, and to prepare for the new lifestyle. In this context, the main subject of this research is to enable individuals to gain healthy lifestyle behaviors by providing mobile-based training and consultancy services that enable them to easily access the right information at the desired time and place.
- Being tested
- mobile education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile educationOther
The training content prepared by the researchers will be presented to the expert opinion. After the necessary arrangements, it will be installed on the mobile application. The mobile application will be downloaded to the patients' phones for one month. It will be in live consultation.
| Study group | Role | What they receive |
|---|---|---|
| application group | Experimental | In addition to standard care, training and consultancy will be provided with a mobile application. Receives: Other: mobile education |
| control group | No intervention | Standard care will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Mobile Health-Education Application on Healthy Lifestyle Behaviors in Patients Planned for Bariatric Surgery
Data will be evaluated using the Healthy Lifestyle Behaviors Scale-II. The minimum score that can be obtained from the 52-item scale is 52, and the maximum score is 208. A high score from the scale indicates that individuals have good HLPS levels, and low scores indicate bad HLBD.
Measured: one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Aug 2022
- Primary completion30 Dec 2023
- Study completion1 Jul 2025 (estimated)
Why it stopped: The study was interrupted due to the small number of patients constituting the sample.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
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
- NCT05428059
- Sponsor's protocol ID
- 5312256943
- Status last verified
- Aug 2024
- First submitted
- 15 Jun 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Health-Education Application on Healthy Lifestyle Behaviors in Patients Planned for Bariatric Surgery:A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05428059
- Acronym / sponsor ID
- 5312256943
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study was interrupted due to the small number of patients constituting the sample.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 22 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.
Obesity, which is the second leading cause of preventable death in the world, affects all the systems in the body and affects many physiological problems, as well as the mental state, body image and quality of life of the individual. For this reason, obese individuals try various treatment methods in order to get rid of obesity, and in cases where these methods fail, they often prefer bariatric surgery. It is very important that patients who will undergo bariatric surgery can adapt to the anatomical changes in their body and shape their lifestyle accordingly. Otherwise, it is inevitable for patients to face various complications after surgery. After bariatric surgery, a structured training program in the preoperative period is of great importance in order for the patient to adapt to the changes in his body, to prevent the development of possible complications, to be affected by the negativities that may occur due to the current change, and to prepare for the new lifestyle. In this context, the main subject of this research is to enable individuals to gain healthy lifestyle behaviors by providing mobile-based training and consultancy services that enable them to easily access the right information at the desired time and place.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| application group | Experimental | Other: mobile educationIn addition to standard care, training and consultancy will be provided with a mobile application. |
| control group | No intervention | –Standard care will be given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being literate,
- Being able to understand, speak Turkish and not have a hearing impairment,
- First time to undergo bariatric surgery,
- Absence of any psychiatric disorder that will reduce the ability to comprehend and understand,
- Ability to use Android-based smartphones,
Key exclusion criteria (1 listed)
- Patient's desire to quit the study
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 |
|---|---|---|
| mobile educationThe training content prepared by the researchers will be presented to the expert opinion. After the necessary arrangements, it will be installed on the mobile application. The mobile application will be downloaded to the patients' phones for one month. It will be in live consultation. | Other | application group |
Primary outcome
The Effect of Mobile Health-Education Application on Healthy Lifestyle Behaviors in Patients Planned for Bariatric Surgery
Time frame: one months
Data will be evaluated using the Healthy Lifestyle Behaviors Scale-II. The minimum score that can be obtained from the 52-item scale is 52, and the maximum score is 208. A high score from the scale indicates that individuals have good HLPS levels, and low scores indicate bad HLBD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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 mobile education in people with Nursing Caries and Bariatric Surgery Candidate, 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 6 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: paused, as of the sponsor's last update on 23 Aug 2024. 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?
Results are not available in the source record.
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?
The Effect of Mobile Health-Education Application on Healthy Lifestyle Behaviors in Patients Planned for Bariatric Surgery (time frame: one months). 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 23 Aug 2024.