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Obesity, MorbidNCT07872605

Structured Perioperative Nursing Education and Short-Term Outcomes After Metabolic Bariatric Surgery

A study testing Structured Perioperative Nursing Education Program in people with Obesity, Morbid and Bariatric Surgery Candidate, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluated whether a structured, nurse-led perioperative education program, supported by an illustrated Arabic booklet, is associated with better short-term outcomes in adults undergoing metabolic and bariatric surgery (MBS). The main outcome was eating behavior at 6 months after surgery. Read more about this study

Who is it for?
Ages 20 to 60 years
What is being tested?
Structured Perioperative Nursing Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteEgypt
Study dates
1 May 2024to 31 Aug 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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adults aged 20 to 60 years
  • Body mass index (BMI) above 35 kg/m²
  • Scheduled for any type of metabolic and bariatric surgery at the Experimental and Clinical Surgery Department, Medical Research Institute, Alexandria University
  • Willing to participate and able to give written informed consent

Who cannot join

  • Age below 20 years or above 60 years
  • BMI of 35 kg/m² or lower
  • Participation in the pilot study used to test the study questionnaires

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Medical Research Institute, Alexandria University

    Alexandria, 21561

Other trials in Egypt

About this study

Official title: Structured Perioperative Nursing Education and Short-Term Outcomes After Metabolic Bariatric Surgery: A Nonrandomized, Temporally Allocated Controlled Study

This study evaluated whether a structured, nurse-led perioperative education program, supported by an illustrated Arabic booklet, is associated with better short-term outcomes in adults undergoing metabolic and bariatric surgery (MBS). The main outcome was eating behavior at 6 months after surgery. Other outcomes were knowledge about bariatric surgery, weight loss, quality of life, and recorded postoperative symptoms and events. Patients who received routine hospital care were compared with patients who received the structured education program.

Read the detailed description

Design: single-center, nonrandomized, temporally allocated controlled (quasi-experimental) study conducted at the inpatient departments and outpatient clinics of the Experimental and Clinical Surgery Department, Medical Research Institute, Alexandria University, Egypt. Reported according to the TREND statement.

Allocation: 86 adults undergoing MBS were enrolled sequentially. The control (usual-care) group (n = 43) was recruited first, from May to August 2024. The intervention group (n = 43) was recruited next, from September 2024 to February 2025. Sequential recruitment was used to limit contamination between groups.

Intervention: two one-to-one, nurse-led education sessions of about 45-60 minutes, the first on the day of surgery and the second on the first postoperative day, using interactive discussion, demonstration and an illustrated booklet in simple Arabic. Content covered obesity and MBS, the expected postoperative course, staged diet progression, hydration, chewing and eating speed, early ambulation, breathing and limb exercises, medication and supplement adherence, smoking restriction, wound care, warning signs of complications, and follow-up. Education was reinforced at routine follow-up visits (2 weeks and 1, 3, 6 and 12 months).

Comparator: routine perioperative nursing care and standard discharge instructions.

Assessments: eating behavior (locally adapted 18-item Three-Factor Eating Questionnaire with uncontrolled eating, cognitive restraint and emotional eating domains) at baseline and 1, 3 and 6 months; a 12-item MBS knowledge questionnaire at baseline and 1 month; weight, BMI, percentage total weight loss and percentage excess BMI loss at baseline and 1, 3 and 6 months; quality of life (Moorehead-Ardelt-based instrument) at baseline, 1 and 6 months; obesity-associated medical conditions; recorded postoperative symptoms and events at 1 and 6 months; and an exploratory BAROS-derived score.

Analysis: the 6-month between-group comparison used analysis of covariance adjusted for the baseline value of each outcome, with sensitivity models adjusted for procedure type (and baseline BMI for weight-loss outcomes).

Registration note: this study was registered retrospectively, after completion of enrollment and follow-up.

Being tested
Structured Perioperative Nursing Education Program
Keywords
Metabolic Bariatric Surgery, Perioperative Nursing Education, Patient Education, Eating Behavior, Sleeve Gastrectomy, Quality of Life
Medical subject headings
Obesity, Morbid, Obesity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured Perioperative Nursing Education ProgramBehavioural

    Nurse-led, one-to-one education delivered in a private room by a trained nurse in two sessions of about 45-60 minutes (day of surgery and first postoperative day), using interactive discussion, demonstration and an illustrated booklet in simple Arabic given to each participant. Topics: obesity and MBS, expected postoperative course, staged diet progression, hydration, chewing and eating speed, early ambulation, breathing and limb exercises, medication and supplement adherence, smoking restriction, wound care, warning signs of complications, and follow-up. Reinforced at routine follow-up visits.

Study groups in NCT07872605
Study groupRoleWhat they receive
Structured Nursing EducationExperimentalAdults undergoing metabolic and bariatric surgery enrolled from September 2024 to February 2025 who received the structured nurse-led perioperative education program (two one-to-one sessions with an illustrated Arabic booklet, reinforced at routine follow-up) in addition to routine care.
Receives: Behavioral: Structured Perioperative Nursing Education Program
Usual Care (Control)No interventionAdults undergoing metabolic and bariatric surgery enrolled from May to August 2024 who received routine hospital perioperative nursing care and standard discharge instructions, without the structured education program or booklet.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eating Behavior Score (Adapted 18-item Three-Factor Eating Questionnaire)

    Eating behavior measured with a locally adapted Arabic 18-item Three-Factor Eating Questionnaire, each item scored on a 3-point scale. Domain scores: uncontrolled eating (9 items, range 9-27), cognitive restraint (6 items, range 6-18) and emotional eating (3 items, range 3-9); total score range 18-54. Higher scores indicate less favorable eating behavior under the study scoring. The 6-month between-group comparison is adjusted for the baseline value.

    Measured: Baseline and 1, 3 and 6 months after surgery (principal comparison at 6 months)

Secondary outcomes (9)

  1. Bariatric Surgery Knowledge Score

    Knowledge of metabolic and bariatric surgery measured with a 12-item investigator-developed structured interview covering surgery, diet, exercise, medication, follow-up and warning symptoms. Each item scored 0-2 (total 0-24); higher scores indicate better knowledge. Also categorized as poor, fair or good knowledge.

    Measured: Baseline and 1 month after surgery

  2. Percentage Total Weight Loss (%TWL)

    %TWL = [(baseline weight - follow-up weight) / baseline weight] x 100.

    Measured: 1, 3 and 6 months after surgery

  3. Percentage Excess BMI Loss (%EBMIL)

    %EBMIL = [(baseline BMI - follow-up BMI) / (baseline BMI - 25 kg/m²)] x 100.

    Measured: 1, 3 and 6 months after surgery

  4. Quality of Life (Moorehead-Ardelt-based Questionnaire)

    Health-related quality of life measured with an investigator-adapted Moorehead-Ardelt quality-of-life questionnaire covering self-esteem, physical activity, social life, work and sexual activity, and eating behavior; results classified from very poor to very good. Higher scores indicate better quality of life.

    Measured: Baseline, 1 month and 6 months after surgery

  5. Number of Participants With Recorded Postoperative Symptoms or Clinical Events

    Patient-reported symptoms and clinical events recorded during routine follow-up (for example vomiting, constipation, dehydration-related symptoms, wound infection, leak, bleeding, pulmonary embolism, reoperation and death), reported individually and as the proportion with at least one recorded symptom or event.

    Measured: 1 and 6 months after surgery

  6. Status of Obesity-associated Medical Conditions

    Change in recorded obesity-associated medical conditions (for example type 2 diabetes, hypertension, dyslipidemia and obstructive sleep apnea) among participants with at least one condition at baseline, classified as improved, unchanged or resolved.

    Measured: 1 and 6 months after surgery

  7. BAROS Total Score (Exploratory)

    Single total score, in points, of the Bariatric Analysis and Reporting Outcome System (BAROS), reconstructed for each participant. Points for weight loss (%EBMIL: 0 for <25%, 1 for 25% to <50%, 2 for 50% to <75%, 3 for 75% or more), change in obesity-associated medical conditions, and quality of life are added, and points are deducted for postoperative events or reoperation. Maximum 9 points; higher scores indicate a better outcome.

    Measured: 1 and 6 months after surgery

  8. Body Weight

    Measured body weight in kilograms (kg).

    Measured: Baseline and 1, 3 and 6 months after surgery

  9. Body Mass Index (BMI)

    BMI in kg/m², calculated from measured body weight (kg) divided by the square of measured height (m).

    Measured: Baseline and 1, 3 and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2026
  2. Study start1 May 2024
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 2025

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Two parallel groups enrolled in consecutive time periods at one center: a usual-care control group recruited first (May-August 2024), followed by a structured nurse-led education group (September 2024-February 2025). Group membership was determined by the enrollment period, not by randomization.
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07872605
Sponsor's protocol ID
NursEdu-MBS-2024
Other IDs
E/C. S/N. R7/2024
Status last verified
Oct 2026
First submitted
5 Oct 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participant-level data are not publicly available because unrestricted public sharing was not covered by participant consent or ethics approval. De-identified data may be made available by the corresponding author on reasonable request, subject to institutional and ethical requirements.

Questions about this trial

What is this clinical trial studying?

A study testing Structured Perioperative Nursing Education Program in people with Obesity, Morbid and Bariatric Surgery Candidate, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 13 Oct 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Eating Behavior Score (Adapted 18-item Three-Factor Eating Questionnaire) (time frame: Baseline and 1, 3 and 6 months after surgery (principal comparison at 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07872605.

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 13 Oct 2026.

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