Obesity (BMI > 35)DigiBarQoLNCT07457034
Digital Follow-Up and Nursing Education in Bariatric Surgery Patients
A study testing Structured Nursing Education and Exercise Program in people with Obesity (BMI > 35) and Bariatric Surgery, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study aims to evaluate the effect of a PHP-MySQL database-based digital follow-up system combined with structured nursing education on quality of life, body mass index (BMI), and exercise habits in patients undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity (BMI > 35), Bariatric Surgery
- What is being tested?
- Structured Nursing Education and Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years Undergoing bariatric surgery Eligible for physical activity participation according to the International Physical Activity Questionnaire (IPAQ) Able to use the PHP-MySQL based digital follow-up system Willing to participate and provide written informed consent
Who cannot join
- Severe cardiopulmonary disease or any medical condition that contraindicates exercise Uncontrolled hypertension or uncontrolled diabetes Severe musculoskeletal limitations preventing participation in the exercise program Severe psychiatric disorder impairing compliance or follow-up Participation in another interventional study during the study period Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
S.B.Ü. Haydarpaşa Numune Eğitim Ve Araştirma Hastanesi
Istanbul, ÜSKÜDAR, 34662
About this study
Official title: The Effect of the Use of a PHP-MySQL Database-Based Follow-Up System and Nursing Education on Quality of Life in Patients Undergoing Bariatric Surgery
This randomized controlled experimental study aims to evaluate the effect of a PHP-MySQL database-based digital follow-up system combined with structured nursing education on quality of life, body mass index (BMI), and exercise habits in patients undergoing bariatric surgery. Although bariatric surgery is an effective treatment for morbid obesity, long-term success depends largely on adherence to lifestyle modifications, including regular physical activity and sustained behavioral change.
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive structured nursing education along with an 8-week digitally monitored exercise program starting at postoperative month four. The control group will receive standard postoperative care. Outcomes will be assessed using the Moorehead-Ardelt Quality of Life Questionnaire II (MA-II), BMI measurements, and the International Physical Activity Questionnaire (IPAQ). The study aims to provide evidence for integrating digital health technologies and structured nursing interventions into postoperative bariatric care.
Read the detailed description
Obesity is a chronic, multifactorial disease associated with increased morbidity, mortality, and reduced quality of life. Bariatric surgery is considered the most effective long-term treatment for morbid obesity; however, sustainable outcomes depend on adherence to postoperative lifestyle modifications, including regular physical activity, nutritional regulation, and behavioral adaptation. Despite the effectiveness of surgery in achieving initial weight loss, some patients experience insufficient weight reduction or weight regain due to poor adherence to recommended lifestyle changes.
Digital health technologies have emerged as promising tools for improving patient monitoring, self-management, and behavioral compliance. Mobile and web-based follow-up systems may enhance communication between patients and healthcare professionals, facilitate structured exercise adherence, and promote sustained behavioral change. Additionally, structured nursing education plays a critical role in empowering patients, increasing health literacy, and improving postoperative adaptation.
This randomized controlled trial aims to evaluate the effectiveness of a PHP-MySQL database-based digital follow-up system combined with structured nursing education in patients undergoing bariatric surgery. Eligible participants will be randomly assigned to intervention and control groups using a simple randomization method. The intervention group will receive structured nursing education and participate in an 8-week digitally monitored exercise program beginning at postoperative month four. The control group will receive standard postoperative care without structured digital follow-up.
Primary outcome measures include changes in quality of life assessed by the Moorehead-Ardelt Quality of Life Questionnaire II (MA-II). Secondary outcomes include changes in body mass index (BMI), physical activity levels measured by the International Physical Activity Questionnaire (IPAQ), and exercise adherence rates recorded through the digital platform.
The findings of this study are expected to contribute to the development of evidence-based postoperative follow-up models integrating digital health systems and nursing-led behavioral interventions in bariatric care.
- Conditions
- Obesity (BMI > 35), Bariatric Surgery
- Being tested
- Structured Nursing Education and Exercise Program
- Keywords
- bariatric surgery, obesity, nursing education, digital health, exercise program, Quality of Life, Physical Activity, Randomized Controlled Trial
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Nursing Education and Exercise ProgramBehavioural
Participants will receive structured nursing education supported by an evidence-based educational brochure and will participate in an 8-week structured exercise program starting at postoperative month four. The program will include stretching, aerobic exercise, and cooling phases, performed at least three times per week for approximately 40 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Nursing Education and Digital Exercise Follow-Up | Experimental | Participants will receive structured nursing education and an 8-week structured exercise program beginning at postoperative month four. Exercise sessions will be performed at least three times per week for approximately 40 minutes per session, including warm-up and cooling phases. Adherence and activity records will be monitored through a secure PHP-MySQL based digital follow-up system. Receives: Behavioral: Structured Nursing Education and Exercise Program |
| Standart Postoperative Care | No intervention | Participants will receive routine postoperative follow-up and standard care without additional structured nursing education or digital exercise monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Qality of Life
Change in Moorehead-Ardelt Quality of Life Questionnaire II (MA-II) total score from baseline to post-intervention.
Measured: Baseline and 8 weeks (postoperative month 4 to month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start7 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI > 35)Studies 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a simple randomization method. The intervention group will receive structured nursing education and participate in an 8-week digitally monitored exercise program beginning at postoperative month four. The control group will receive standard postoperative care without structured digital follow-up or additional educational intervention. Both groups will be followed over the same study period, and outcome measures will be assessed comparatively.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Responsible party
- Principal investigator, Seda Akkaya, Okan University
- Investigators
- SEDA AKKAYA, MSc, Principal investigator, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457034
- Sponsor's protocol ID
- OKANU-SBÜ-SA-02
- Acronym
- DigiBarQoL
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of a PHP-MySQL Database-Based Follow-Up System and Nursing Education on Quality of Life in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07457034
- Acronym / sponsor ID
- DigiBarQoL / OKANU-SBÜ-SA-02
- Conditions
- Obesity (BMI > 35), Bariatric Surgery
- Keywords
- bariatric surgery, obesity, nursing education, digital health, exercise program, Quality of Life, Physical Activity, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Study start
- 7 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Mar 2026 (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 randomized controlled experimental study aims to evaluate the effect of a PHP-MySQL database-based digital follow-up system combined with structured nursing education on quality of life, body mass index (BMI), and exercise habits in patients undergoing bariatric surgery. Although bariatric surgery is an effective treatment for morbid obesity, long-term success depends largely on adherence to lifestyle modifications, including regular physical activity and sustained behavioral change.
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive structured nursing education along with an 8-week digitally monitored exercise program starting at postoperative month four. The control group will receive standard postoperative care. Outcomes will be assessed using the Moorehead-Ardelt Quality of Life Questionnaire II (MA-II), BMI measurements, and the International Physical Activity Questionnaire (IPAQ). The study aims to provide evidence for integrating digital health technologies and structured nursing interventions into postoperative bariatric care.
Detailed description
Obesity is a chronic, multifactorial disease associated with increased morbidity, mortality, and reduced quality of life. Bariatric surgery is considered the most effective long-term treatment for morbid obesity; however, sustainable outcomes depend on adherence to postoperative lifestyle modifications, including regular physical activity, nutritional regulation, and behavioral adaptation. Despite the effectiveness of surgery in achieving initial weight loss, some patients experience insufficient weight reduction or weight regain due to poor adherence to recommended lifestyle changes.
Digital health technologies have emerged as promising tools for improving patient monitoring, self-management, and behavioral compliance. Mobile and web-based follow-up systems may enhance communication between patients and healthcare professionals, facilitate structured exercise adherence, and promote sustained behavioral change. Additionally, structured nursing education plays a critical role in empowering patients, increasing health literacy, and improving postoperative adaptation.
This randomized controlled trial aims to evaluate the effectiveness of a PHP-MySQL database-based digital follow-up system combined with structured nursing education in patients undergoing bariatric surgery. Eligible participants will be randomly assigned to intervention and control groups using a simple randomization method. The intervention group will receive structured nursing education and participate in an 8-week digitally monitored exercise program beginning at postoperative month four. The control group will receive standard postoperative care without structured digital follow-up.
Primary outcome measures include changes in quality of life assessed by the Moorehead-Ardelt Quality of Life Questionnaire II (MA-II). Secondary outcomes include changes in body mass index (BMI), physical activity levels measured by the International Physical Activity Questionnaire (IPAQ), and exercise adherence rates recorded through the digital platform.
The findings of this study are expected to contribute to the development of evidence-based postoperative follow-up models integrating digital health systems and nursing-led behavioral interventions in bariatric care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a simple randomization method. The intervention group will receive structured nursing education and participate in an 8-week digitally monitored exercise program beginning at postoperative month four. The control group will receive standard postoperative care without structured digital follow-up or additional educational intervention. Both groups will be followed over the same study period, and outcome measures will be assessed comparatively.
| Arm | Type | Receives |
|---|---|---|
| Nursing Education and Digital Exercise Follow-Up | Experimental | Behavioral: Structured Nursing Education and Exercise ProgramParticipants will receive structured nursing education and an 8-week structured exercise program beginning at postoperative month four. Exercise sessions will be performed at least three times per week for approximately 40 minutes per session, including warm-up and cooling phases. Adherence and activity records will be monitored through a secure PHP-MySQL based digital follow-up system. |
| Standart Postoperative Care | No intervention | –Participants will receive routine postoperative follow-up and standard care without additional structured nursing education or digital exercise monitoring. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18-65 years Undergoing bariatric surgery Eligible for physical activity participation according to the International Physical Activity Questionnaire (IPAQ) Able to use the PHP-MySQL based digital follow-up system Willing to participate and provide written informed consent
Key exclusion criteria (1 listed)
- Severe cardiopulmonary disease or any medical condition that contraindicates exercise Uncontrolled hypertension or uncontrolled diabetes Severe musculoskeletal limitations preventing participation in the exercise program Severe psychiatric disorder impairing compliance or follow-up Participation in another interventional study during the study period Refusal or inability to provide informed consent
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 |
|---|---|---|
| Structured Nursing Education and Exercise ProgramParticipants will receive structured nursing education supported by an evidence-based educational brochure and will participate in an 8-week structured exercise program starting at postoperative month four. The program will include stretching, aerobic exercise, and cooling phases, performed at least three times per week for approximately 40 minutes per session. | Behavioural | Nursing Education and Digital Exercise Follow-Up |
Primary outcome
Change in Qality of Life
Time frame: Baseline and 8 weeks (postoperative month 4 to month 6)
Change in Moorehead-Ardelt Quality of Life Questionnaire II (MA-II) total score from baseline to post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available due to privacy and ethical restrictions.
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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.
SEDA AKKAYA, MSc principal investigator
Okan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Nursing Education and Exercise Program in people with Obesity (BMI > 35) and Bariatric Surgery, run by Okan 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 1 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seda AKKAYA, MSc (5057678339, sedakkaya@stu.okan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Qality of Life (time frame: Baseline and 8 weeks (postoperative month 4 to month 6)). 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 28 Jul 2026.