ClinicalTrials.gg
RecruitingNCT07457034DigiBarQoLUpdated Jul 28, 2026

Digital Follow-Up and Nursing Education in Bariatric Surgery Patients

An interventional study of Structured Nursing Education and Exercise Program in Obesity (BMI > 35) and Bariatric Surgery, sponsored by Okan University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Okan University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity (BMI > 35)
  • Bariatric Surgery

Keywords

  • bariatric surgery
  • obesity
  • nursing education
  • digital health
  • exercise program
  • Quality of Life
  • Physical Activity
  • Randomized Controlled Trial
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 52 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Okan University is the lead sponsor of 97 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Nursing Education and Digital Exercise Follow-Up

    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.

    Behavioral: Structured Nursing Education and Exercise Program

  • No intervention
    Standart Postoperative Care

    Participants will receive routine postoperative follow-up and standard care without additional structured nursing education or digital exercise monitoring.

Interventions

  • BehavioralStructured Nursing Education and Exercise Program

    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.

06

What researchers measure

Primary outcomes

  1. Change in Qality of Life

    Change in Moorehead-Ardelt Quality of Life Questionnaire II (MA-II) total score from baseline to post-intervention.

    Time frame: Baseline and 8 weeks (postoperative month 4 to month 6)

07

Study locations

1 of 1 sites recruiting
  • S.B.Ü. Haydarpaşa Numune Eğitim Ve Araştirma Hastanesi
    Istanbul, ÜSKÜDAR 34662, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be publicly available due to privacy and ethical restrictions.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 9 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2026
First posted
Mar 9, 2026
StartActual
Mar 7, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07457034
Lead sponsor
Okan University
Collaborators
Haydarpasa Numune Training and Research Hospital
Responsible party
Seda Akkaya (PhD Candidate, Okan University) — Principal investigator
First posted
Mar 9, 2026
Start date
Mar 7, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 28, 2026

Study contacts

Seda AKKAYA, MSc
Contact
sedakkaya@stu.okan.edu.tr
5057678339
İLKNUR ÇALIŞKAN, Assistant Professor
Contact
sedakkaya@stu.okan.edu.tr
5367237207
SEDA AKKAYA, MSc
principal investigator · Okan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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