Lifestyle AdherencePONLCPNCT07920016
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
A study testing Early Postoperative Nurse-Led Individualized Lifestyle Counseling Program in people with Lifestyle Adherence, run by University of Basrah at 1 site in Iraq.
Trial summary
Bariatric surgery can help people achieve significant weight loss and improve obesity-related health conditions. However, maintaining these benefits requires long-term adherence to recommended lifestyle changes, including healthy eating habits, regular physical activity, taking prescribed vitamin and mineral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lifestyle Adherence
- What is being tested?
- Early Postoperative Nurse-Led Individualized Lifestyle Counseling Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteIraq
- Study dates
- 13 Nov 2026to 30 May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Patients who have undergone bariatric surgery (e.g., sleeve gastrectomy or Roux-en-Y gastric bypass).
- Patients in the early postoperative period following bariatric surgery.
- Patients who are medically stable and able to participate in the nurse-led counseling sessions.
- Patients who are able to understand and communicate in Arabic.
- Patients who are willing to participate and provide written informed consent.
Who cannot join
- Patients who experience major postoperative complications or require prolonged hospitalization that prevents participation in the counseling program.
- Patients with severe cognitive impairment or communication difficulties that prevent them from understanding the counseling sessions or completing the study assessments.
- Patients who are participating in another structured behavioral or lifestyle counseling intervention during the study period.
- Patients who are unable or unwilling to complete the planned follow-up assessments.
- Patients who have previously undergone bariatric surgery (revision surgery), if the study is restricted to patients undergoing their first bariatric procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
College of Nursing, University of Basrah
Basra, Basrah, 61004
Sundus B Sundus Baqer Dawood, PhD, +9647707096503, sindus.dawood@uobasrah.edu.iq
About this study
Bariatric surgery can help people achieve significant weight loss and improve obesity-related health conditions. However, maintaining these benefits requires long-term adherence to recommended lifestyle changes, including healthy eating habits, regular physical activity, taking prescribed vitamin and mineral supplements, following medication recommendations, and attending scheduled postoperative appointments.
Some patients experience difficulties following these recommendations during the first months after surgery, which may affect their recovery and long-term health outcomes.
Read more
The purpose of this study is to evaluate whether an early postoperative, nurse-led, individualized counseling program can improve adherence to lifestyle recommendations among adults who have undergone bariatric surgery.
Participants will be randomly assigned to one of two groups. The intervention group will receive an individualized counseling program delivered by a trained nurse, in addition to routine postoperative care. The program will focus on identifying individual barriers to lifestyle adherence, providing tailored education and counseling, setting realistic goals, developing personalized action plans, and reinforcing recommended self-management behaviors. The control group will receive routine postoperative care.
The study will assess participants' adherence to recommended postoperative lifestyle behaviors, including dietary recommendations, physical activity, vitamin and mineral supplementation, medication use, and attendance at scheduled follow-up appointments.
It is hypothesized that participants receiving the individualized nurse-led counseling program will demonstrate better adherence to postoperative lifestyle recommendations than those receiving routine care alone.
The findings may help identify an effective nursing approach to supporting patients during early recovery after bariatric surgery and maintaining recommended lifestyle changes.
Read the detailed description
Background and Rationale
Bariatric surgery is an effective treatment for severe obesity and is associated with substantial weight loss and improvement in obesity-related comorbidities. However, the long-term effectiveness of bariatric surgery depends not only on the surgical procedure but also on patients' ability to maintain recommended postoperative lifestyle behaviors.
Following bariatric surgery, patients are expected to adopt several behavioral and self-management recommendations, including adherence to staged dietary progression, appropriate food choices and portion sizes, adequate protein and fluid intake, regular physical activity, lifelong vitamin and mineral supplementation, adherence to prescribed medications, and attendance at scheduled postoperative follow-up appointments.
The early postoperative period represents an important stage for establishing these behaviors. During this period, patients may experience difficulties adapting to dietary restrictions, maintaining physical activity, remembering supplementation schedules, understanding postoperative recommendations, and managing practical or personal barriers to adherence.
Although routine postoperative education provides essential information, standardized educational approaches may not adequately address the individual needs and barriers experienced by each patient. A personalized nurse-led counseling approach may provide additional support by identifying individual challenges, tailoring educational messages, facilitating realistic goal setting, and strengthening patients' ability to manage postoperative lifestyle recommendations.
Study Aim
The aim of this randomized controlled trial is to evaluate the effectiveness of an early postoperative, nurse-led, individualized counseling program in improving adherence to recommended lifestyle behaviors among adults following bariatric surgery.
Intervention Overview
The intervention will consist of a structured, individualized counseling program delivered by a trained nurse in addition to routine postoperative care.
The counseling program will be designed to address the multiple behavioral requirements associated with postoperative bariatric care. Its main components will include:
- Individualized assessment: Identification of patients' current self-management practices, educational needs, perceived barriers, and difficulties in following postoperative recommendations.
- Dietary adherence counseling: Reinforcement of recommended postoperative dietary progression, portion control, appropriate food selection, protein intake, hydration, and strategies for managing common eating-related difficulties.
- Physical activity counseling: Guidance on gradually adopting appropriate physical activity according to the patient's postoperative recovery stage and clinical recommendations.
- Vitamin and mineral supplementation: Education about the importance of prescribed supplementation, appropriate administration, and strategies to improve consistency of use.
- Medication adherence: Counseling regarding prescribed postoperative medications and strategies to overcome medication-taking difficulties.
- Follow-up appointment adherence: Reinforcement of the importance of scheduled postoperative clinical visits and strategies to prevent missed appointments.
- Personalized goal setting and action planning: Development of realistic, individualized behavioral goals and practical action plans based on each patient's identified needs.
- Reinforcement and teach-back: Assessment of patients' understanding of recommendations through teach-back and reinforcement of important self-management messages.
The intervention will be delivered according to a standardized counseling protocol while allowing individualization based on participants' needs and identified barriers. Intervention fidelity will be supported through standardized educational materials and a structured counseling checklist.
Control Group
Participants assigned to the control group will receive routine postoperative care according to the standard practices of the participating clinical setting. This may include routine clinical follow-up and standard postoperative education provided by the healthcare team. No additional structured individualized nurse-led counseling program will be provided to this group.
Study Hypothesis
The study hypothesizes that adults receiving early postoperative individualized nurse-led counseling, in addition to routine postoperative care, will demonstrate greater adherence to recommended lifestyle behaviors than adults receiving routine postoperative care alone.
The study will provide evidence regarding the potential contribution of individualized nursing counseling to postoperative self-management and adherence following bariatric surgery.
- Conditions
- Lifestyle Adherence
- Being tested
- Early Postoperative Nurse-Led Individualized Lifestyle Counseling Program
- Keywords
- Early Postoperative, Nurse-Led, Individualized Counseling Program, Lifestyle Adherence, Bariatric Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Postoperative Nurse-Led Individualized Lifestyle Counseling ProgramBehavioural
A structured, early postoperative nurse-led individualized counseling program designed to improve adherence to lifestyle recommendations among adults following bariatric surgery. The intervention includes individualized assessment of adherence barriers and self-management needs, tailored education and counseling on postoperative dietary recommendations, physical activity, vitamin and mineral supplementation, prescribed medication use, and attendance at scheduled follow-up appointments. Participants will receive personalized goal setting, action planning, problem-solving support, and teach-back to reinforce understanding and adherence. Counseling will be tailored to each participant's needs and stage of postoperative recovery and will be delivered in addition to routine postoperative care by a trained nurse using a standardized intervention protocol.
| Study group | Role | What they receive |
|---|---|---|
| Early Nurse-Led Individualized Counseling Group | Experimental | Participants will receive an early postoperative nurse-led individualized counseling program in addition to routine postoperative care. The program will include individualized assessment of lifestyle adherence barriers, tailored education, dietary adherence counseling, physical activity guidance, vitamin and mineral supplementation, medication adherence support, follow-up appointment adherence, personalized goal setting, action planning, and teach-back. Counseling will be tailored to each participant's needs and postoperative recovery stage. Receives: Behavioral: Early Postoperative Nurse-Led Individualized Lifestyle Counseling Program |
| Usual Postoperative Care Control Group | No intervention | Participants will receive routine postoperative care according to the standard practices of the participating bariatric surgery center. Routine care may include standard postoperative education, scheduled clinical follow-up, and usual recommendations regarding diet, physical activity, vitamin and mineral supplementation, and prescribed medications. Participants will not receive the additional structured nurse-led individualized counseling program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dietary Adherence Score from Baseline to Follow-Up
Dietary adherence will be assessed using a validated questionnaire or structured assessment tool appropriate for patients following bariatric surgery. The assessment will evaluate adherence to recommended postoperative dietary practices, including dietary progression, portion control, food choices, protein intake, and hydration recommendations. Scores will be measured at baseline and follow-up, and changes will be compared between the intervention and control groups. Scoring will follow the selected instrument's guidelines.
Measured: Baseline and 12 weeks after randomization.
Secondary outcomes (1)
Change in Physical Activity Adherence from Baseline to Follow-Up
Adherence to recommended postoperative physical activity will be assessed using an appropriate validated physical activity assessment tool. The assessment will evaluate participants' engagement in physical activity according to postoperative recommendations and their recovery stage. Changes from baseline to follow-up will be compared between the intervention and control groups.
Measured: Baseline and 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start13 Nov 2026 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle AdherenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Eligible adults who have undergone bariatric surgery will be randomly assigned to either an intervention group receiving an early postoperative nurse-led individualized counseling program in addition to routine postoperative care or a control group receiving routine postoperative care alone. Both groups will be assessed at baseline and at the prespecified follow-up time points to evaluate adherence to postoperative lifestyle recommendations.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basrah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Malik Tiryag, University of Basrah
- Investigators
- Ali M Tiryag, PhD, Study chair, College of Nursing, University of Basrah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920016
- Sponsor's protocol ID
- 3/7/1669
- Acronym
- PONLCP
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. The study data will be used exclusively for the purposes of the present research. Participant confidentiality and data privacy will be maintained in accordance with institutional ethical requirements and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07920016
- Acronym / sponsor ID
- PONLCP / 3/7/1669
- Conditions
- Lifestyle Adherence
- Keywords
- Early Postoperative, Nurse-Led, Individualized Counseling Program, Lifestyle Adherence, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of BasrahUniversity, hospital or other
- Study start
- 13 Nov 2026 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 5 Nov 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.
Bariatric surgery can help people achieve significant weight loss and improve obesity-related health conditions. However, maintaining these benefits requires long-term adherence to recommended lifestyle changes, including healthy eating habits, regular physical activity, taking prescribed vitamin and mineral supplements, following medication recommendations, and attending scheduled postoperative appointments.
Some patients experience difficulties following these recommendations during the first months after surgery, which may affect their recovery and long-term health outcomes.
The purpose of this study is to evaluate whether an early postoperative, nurse-led, individualized counseling program can improve adherence to lifestyle recommendations among adults who have undergone bariatric surgery.
Participants will be randomly assigned to one of two groups. The intervention group will receive an individualized counseling program delivered by a trained nurse, in addition to routine postoperative care. The program will focus on identifying individual barriers to lifestyle adherence, providing tailored education and counseling, setting realistic goals, developing personalized action plans, and reinforcing recommended self-management behaviors. The control group will receive routine postoperative care.
The study will assess participants' adherence to recommended postoperative lifestyle behaviors, including dietary recommendations, physical activity, vitamin and mineral supplementation, medication use, and attendance at scheduled follow-up appointments.
It is hypothesized that participants receiving the individualized nurse-led counseling program will demonstrate better adherence to postoperative lifestyle recommendations than those receiving routine care alone.
The findings may help identify an effective nursing approach to supporting patients during early recovery after bariatric surgery and maintaining recommended lifestyle changes.
Detailed description
Background and Rationale
Bariatric surgery is an effective treatment for severe obesity and is associated with substantial weight loss and improvement in obesity-related comorbidities. However, the long-term effectiveness of bariatric surgery depends not only on the surgical procedure but also on patients' ability to maintain recommended postoperative lifestyle behaviors.
Following bariatric surgery, patients are expected to adopt several behavioral and self-management recommendations, including adherence to staged dietary progression, appropriate food choices and portion sizes, adequate protein and fluid intake, regular physical activity, lifelong vitamin and mineral supplementation, adherence to prescribed medications, and attendance at scheduled postoperative follow-up appointments.
The early postoperative period represents an important stage for establishing these behaviors. During this period, patients may experience difficulties adapting to dietary restrictions, maintaining physical activity, remembering supplementation schedules, understanding postoperative recommendations, and managing practical or personal barriers to adherence.
Although routine postoperative education provides essential information, standardized educational approaches may not adequately address the individual needs and barriers experienced by each patient. A personalized nurse-led counseling approach may provide additional support by identifying individual challenges, tailoring educational messages, facilitating realistic goal setting, and strengthening patients' ability to manage postoperative lifestyle recommendations.
Study Aim
The aim of this randomized controlled trial is to evaluate the effectiveness of an early postoperative, nurse-led, individualized counseling program in improving adherence to recommended lifestyle behaviors among adults following bariatric surgery.
Intervention Overview
The intervention will consist of a structured, individualized counseling program delivered by a trained nurse in addition to routine postoperative care.
The counseling program will be designed to address the multiple behavioral requirements associated with postoperative bariatric care. Its main components will include:
- Individualized assessment: Identification of patients' current self-management practices, educational needs, perceived barriers, and difficulties in following postoperative recommendations.
- Dietary adherence counseling: Reinforcement of recommended postoperative dietary progression, portion control, appropriate food selection, protein intake, hydration, and strategies for managing common eating-related difficulties.
- Physical activity counseling: Guidance on gradually adopting appropriate physical activity according to the patient's postoperative recovery stage and clinical recommendations.
- Vitamin and mineral supplementation: Education about the importance of prescribed supplementation, appropriate administration, and strategies to improve consistency of use.
- Medication adherence: Counseling regarding prescribed postoperative medications and strategies to overcome medication-taking difficulties.
- Follow-up appointment adherence: Reinforcement of the importance of scheduled postoperative clinical visits and strategies to prevent missed appointments.
- Personalized goal setting and action planning: Development of realistic, individualized behavioral goals and practical action plans based on each patient's identified needs.
- Reinforcement and teach-back: Assessment of patients' understanding of recommendations through teach-back and reinforcement of important self-management messages.
The intervention will be delivered according to a standardized counseling protocol while allowing individualization based on participants' needs and identified barriers. Intervention fidelity will be supported through standardized educational materials and a structured counseling checklist.
Control Group
Participants assigned to the control group will receive routine postoperative care according to the standard practices of the participating clinical setting. This may include routine clinical follow-up and standard postoperative education provided by the healthcare team. No additional structured individualized nurse-led counseling program will be provided to this group.
Study Hypothesis
The study hypothesizes that adults receiving early postoperative individualized nurse-led counseling, in addition to routine postoperative care, will demonstrate greater adherence to recommended lifestyle behaviors than adults receiving routine postoperative care alone.
The study will provide evidence regarding the potential contribution of individualized nursing counseling to postoperative self-management and adherence following bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Eligible adults who have undergone bariatric surgery will be randomly assigned to either an intervention group receiving an early postoperative nurse-led individualized counseling program in addition to routine postoperative care or a control group receiving routine postoperative care alone. Both groups will be assessed at baseline and at the prespecified follow-up time points to evaluate adherence to postoperative lifestyle recommendations.
| Arm | Type | Receives |
|---|---|---|
| Early Nurse-Led Individualized Counseling Group | Experimental | Behavioral: Early Postoperative Nurse-Led Individualized Lifestyle Counseling ProgramParticipants will receive an early postoperative nurse-led individualized counseling program in addition to routine postoperative care. The program will include individualized assessment of lifestyle adherence barriers, tailored education, dietary adherence counseling, physical activity guidance, vitamin and mineral supplementation, medication adherence support, follow-up appointment adherence, personalized goal setting, action planning, and teach-back. Counseling will be tailored to each participant's needs and postoperative recovery stage. |
| Usual Postoperative Care Control Group | No intervention | –Participants will receive routine postoperative care according to the standard practices of the participating bariatric surgery center. Routine care may include standard postoperative education, scheduled clinical follow-up, and usual recommendations regarding diet, physical activity, vitamin and mineral supplementation, and prescribed medications. Participants will not receive the additional structured nurse-led individualized counseling program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Patients who have undergone bariatric surgery (e.g., sleeve gastrectomy or Roux-en-Y gastric bypass).
- Patients in the early postoperative period following bariatric surgery.
- Patients who are medically stable and able to participate in the nurse-led counseling sessions.
- Patients who are able to understand and communicate in Arabic.
Key exclusion criteria (5 listed)
- Patients who experience major postoperative complications or require prolonged hospitalization that prevents participation in the counseling program.
- Patients with severe cognitive impairment or communication difficulties that prevent them from understanding the counseling sessions or completing the study assessments.
- Patients who are participating in another structured behavioral or lifestyle counseling intervention during the study period.
- Patients who are unable or unwilling to complete the planned follow-up assessments.
- Patients who have previously undergone bariatric surgery (revision surgery), if the study is restricted to patients undergoing their first bariatric procedure.
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 |
|---|---|---|
| Early Postoperative Nurse-Led Individualized Lifestyle Counseling ProgramA structured, early postoperative nurse-led individualized counseling program designed to improve adherence to lifestyle recommendations among adults following bariatric surgery. The intervention includes individualized assessment of adherence barriers and self-management needs, tailored education and counseling on postoperative dietary recommendations, physical activity, vitamin and mineral supplementation, prescribed medication use, and attendance at scheduled follow-up appointments. Participants will receive personalized goal setting, action planning, problem-solving support, and teach-back to reinforce understanding and adherence. Counseling will be tailored to each participant's needs and stage of postoperative recovery and will be delivered in addition to routine postoperative care by a trained nurse using a standardized intervention protocol. | Behavioural | Early Nurse-Led Individualized Counseling Group |
Primary outcome
Change in Dietary Adherence Score from Baseline to Follow-Up
Time frame: Baseline and 12 weeks after randomization.
Dietary adherence will be assessed using a validated questionnaire or structured assessment tool appropriate for patients following bariatric surgery. The assessment will evaluate adherence to recommended postoperative dietary practices, including dietary progression, portion control, food choices, protein intake, and hydration recommendations. Scores will be measured at baseline and follow-up, and changes will be compared between the intervention and control groups. Scoring will follow the selected instrument's guidelines.
1 secondary outcome
Change in Physical Activity Adherence from Baseline to Follow-Up
Time frame: Baseline and 12 weeks after randomization
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 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. The study data will be used exclusively for the purposes of the present research. Participant confidentiality and data privacy will be maintained in accordance with institutional ethical requirements and applicable data protection regulations.
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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.
Ali M Tiryag, PhD study chair
College of Nursing, University of Basrah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Postoperative Nurse-Led Individualized Lifestyle Counseling Program in people with Lifestyle Adherence, run by University of Basrah at 1 site in Iraq.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Nov 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 Iraq. 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 Ali M Dr. Ali Malik Tiryag, PhD (+9647811735332, ali.malik@uobasrah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dietary Adherence Score from Baseline to Follow-Up (time frame: Baseline and 12 weeks after randomization.). 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 5 Nov 2026.