NCT07457034

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

March 3, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 7, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

bariatric surgeryobesitynursing educationdigital healthexercise programQuality of LifePhysical ActivityRandomized Controlled Trial

Outcome Measures

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.

    Baseline and 8 weeks (postoperative month 4 to month 6)

Study Arms (2)

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.

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.

Interventions

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.

Nursing Education and Digital Exercise Follow-Up

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • SEDA AKKAYA, MSc

    Okan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İLKNUR ÇALIŞKAN, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

March 7, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly available due to privacy and ethical restrictions.