Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:44 PM
Study NCT ID:
NCT07457034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Follow-Up and Nursing Education in Bariatric Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Due to the behavioral and educational nature of the intervention, blinding of participants and researchers is not feasible. Therefore, this study will be conducted as an open-label randomized controlled trial.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Qality of Life', 'timeFrame': 'Baseline and 8 weeks (postoperative month 4 to month 6)', 'description': 'Change in Moorehead-Ardelt Quality of Life Questionnaire II (MA-II) total score from baseline to post-intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'obesity', 'nursing education', 'digital health', 'exercise program', 'Quality of Life', 'Physical Activity', 'Randomized Controlled Trial'], 'conditions': ['Obesity (BMI > 35)', 'Bariatric Surgery']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.', 'detailedDescription': '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.\n\nDigital 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.\n\nThis 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.\n\nPrimary 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT07457034', 'acronym': 'DigiBarQoL', 'briefTitle': 'Digital Follow-Up and Nursing Education in Bariatric Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Okan University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'OKANU-SBÜ-SA-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nursing Education and Digital Exercise Follow-Up', 'description': '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.', 'interventionNames': ['Behavioral: Structured Nursing Education and Exercise Program']}, {'type': 'NO_INTERVENTION', 'label': 'Standart Postoperative Care', 'description': 'Participants will receive routine postoperative follow-up and standard care without additional structured nursing education or digital exercise monitoring.'}], 'interventions': [{'name': 'Structured Nursing Education and Exercise Program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Nursing Education and Digital Exercise Follow-Up']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Seda AKKAYA, MSc', 'role': 'CONTACT', 'email': 'sedakkaya@stu.okan.edu.tr', 'phone': '5057678339'}, {'name': 'İLKNUR ÇALIŞKAN, Assistant Professor', 'role': 'CONTACT', 'email': 'sedakkaya@stu.okan.edu.tr', 'phone': '5367237207'}], 'overallOfficials': [{'name': 'SEDA AKKAYA, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Okan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be publicly available due to privacy and ethical restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Seda Akkaya', 'investigatorAffiliation': 'Okan University'}}}}