Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial (PONLCP)
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.
調査の概要
状態
詳細な説明
**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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ali M Dr. Ali Malik Tiryag, PhD
- 電話番号：+9647811735332
- メール：ali.malik@uobasrah.edu.iq
研究場所
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Basrah
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Basra、Basrah、イラク、61004
- College of Nursing, University of Basrah
-
コンタクト：
- Sundus B Sundus Baqer Dawood, PhD
- 電話番号：+9647707096503
- メール：sindus.dawood@uobasrah.edu.iq
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
**Inclusion Criteria**
- 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.
**Exclusion Criteria**
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Early Nurse-Led Individualized Counseling Group
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. |
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. |
|
介入なし：Usual Postoperative Care Control Group
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Dietary Adherence Score from Baseline to Follow-Up
時間枠：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. |
Baseline and 12 weeks after randomization.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Physical Activity Adherence from Baseline to Follow-Up
時間枠：Baseline and 12 weeks after randomization
|
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. |
Baseline and 12 weeks after randomization
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Ali M Tiryag, PhD、College of Nursing, University of Basrah
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 3/7/1669
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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