An interventional study of Early Postoperative Nurse-Led Individualized Lifestyle Counseling Program in Lifestyle Adherence, sponsored by University of Basrah. Not yet recruiting at 1 site in Iraq. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Basrah · Not applicable, Interventional, and Treatment
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.
**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:
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.
University of Basrah is the lead sponsor of 8 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
**Inclusion Criteria**
**Exclusion Criteria**
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Early Postoperative Nurse-Led Individualized Lifestyle Counseling Program
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.
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.
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.
Time frame: Baseline and 12 weeks after randomization.
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.
Time frame: Baseline and 12 weeks after randomization
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Basrah