Client-Centered Breastfeeding Support: Effects on Primipara Mothers in a Randomized Trial Breastfeeding Self-Efficacy, Attitudes, and Problems in Primiparous Mothers: A Randomized Controlled Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: IMCHB-Based Breastfeeding Support Program, Standard Breastfeeding Education.
- Кому может быть актуально
- Состояния в реестре: Breastfeeding Self-Efficacy Attitude to Health Postpartum Period Primiparity. Базовые параметры: 15 лет — 35 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of an Interaction Model of a Client Health Behavior-Based Breastfeeding Support Program on Breastfeeding Self-Efficacy, Attitudes, and Problems in Primiparous Mothers: A Randomized Controlled Trial
Обзор
Study Description The goal of this randomized controlled trial is to examine the effects of a client health behavior interaction model-based breastfeeding support program on breastfeeding self-efficacy, attitudes, and problems in primipara mothers. The main questions it aims to answer are: 1. How does the program influence mothers' self-efficacy in breastfeeding? 2. What impact does the program have on mothers' attitudes towards breastfeeding and the problems they encounter? Participants will: 1. Receive breastfeeding support through an interactive health behavior model. 2. Participate in assessments of their breastfeeding self-efficacy and attitudes at designated intervals throughout the study duration. There is a comparison group: 1\. Researchers will compare the intervention group (mothers receiving the structured program) to a control group (mothers receiving standard care) to see if there is a significant difference in outcomes related to breastfeeding self-efficacy, attitudes, and encountered problems.
Подробное описание
Study Title:
The Effect of an Interaction Model of a Client Health Behavior-Based Breastfeeding Support Program on Breastfeeding Self-Efficacy, Attitudes, and Problems in Primiparous Mothers: A Randomized Controlled Trial
Objective:
The primary aim of this study is to investigate the impact of a breastfeeding support program, based on a client health behavior interaction model, on the breastfeeding self-efficacy, attitudes, and problems of first-time mothers.
Background:
Breastfeeding is recognized as the gold standard for infant nutrition, offering numerous health benefits to both infants and mothers. Despite its benefits, breastfeeding rates remain suboptimal globally, with many mothers encountering challenges that hinder breastfeeding practices. Innovative support programs are necessary to enhance breastfeeding self-efficacy and improve attitudes towards breastfeeding, especially among primipara mothers.
Study Design:
This study is a randomized controlled trial with a pretest-posttest design. The study will be conducted at Family Health Centers in Denizli, Turkey, from September 2024 to December 2026.
Population:
The study will include primipara mothers who are between 32 and 40 weeks of gestation at the time of recruitment. Participants will be randomly assigned to either the intervention group or the control group.
Intervention:
The intervention group will receive a structured breastfeeding support program based on the Interaction Model of Client Health Behavior (IMCHB). This program includes:
* Educational Sessions: In-person sessions and educational materials (brochures and videos) provided during the last trimester of pregnancy. * Motivational Interviews: Five face-to-face motivational interviews conducted postpartum at specific intervals (1-3 days, 15 days, 30 days, 45 days, and 60 days after birth) to address individual challenges and provide tailored support. * Follow-Up Support: Two additional follow-up sessions via WhatsApp video calls at 4 months and 5 months postpartum to reinforce the intervention and provide ongoing support.
Control Group:
The control group will receive the standard care provided at Family Health Centers, which includes routine breastfeeding education and support, without the additional structured program.
Data Collection:
Data will be collected at multiple time points:
* Baseline (32-36 weeks of gestation): Initial assessment of demographic information, breastfeeding self-efficacy, and attitudes. * Postpartum Assessments: Data collection at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months postpartum using structured questionnaires and scales.
Key Components of the Intervention:
* Educational Content: Development and dissemination of educational materials based on the IMCHB model, addressing common breastfeeding issues and techniques. * Motivational Interviewing: Conducted by trained health professionals, focusing on enhancing motivation and addressing barriers to successful breastfeeding.
Support Tools: Use of mobile communication (WhatsApp) to provide additional support and ensure accessibility.
Outcomes:
The primary outcomes include changes in breastfeeding self-efficacy and attitudes, as measured by validated scales. Secondary outcomes involve the frequency and nature of breastfeeding problems reported by participants.
Hypotheses:
1. Mothers in the intervention group will demonstrate higher breastfeeding self-efficacy compared to the control group. 2. Mothers in the intervention group will have more positive attitudes towards breastfeeding compared to the control group. 3. Mothers in the intervention group will report fewer breastfeeding problems compared to the control group.
Statistical Analysis:
Data will be analyzed using the Statistical Package for the Social Sciences (SPSS). Descriptive statistics will summarize the demographic data. Comparative analyses (e.g., t-tests, ANOVA) will be conducted to evaluate differences between the intervention and control groups. Longitudinal data will be analyzed using repeated measures ANOVA to assess changes over time.
Ethical Considerations:
The study has received approval from the Pamukkale University Non-Interventional Clinical Research Ethics Committee. Informed consent will be obtained from all participants. Confidentiality and data security measures will be strictly followed throughout the study.
Вмешательства
- Поведенческое IMCHB-Based Breastfeeding Support Program
This intervention includes a structured breastfeeding support program based on the Interaction Model of Client Health Behavior (IMCHB). It consists of: Educational Sessions: Conducted during the last trimester of pregnancy to provide information and prepare mothers for breastfeeding. Motivational Interviews: Conducted face-to-face at 1-3 days, 15 days, 30 days, 45 days, and 60 days postpartum to address individual challenges and provide personalized support. Follow-Up Support: Two follow-up s - Поведенческое Standard Breastfeeding Education
Participants receive the standard care provided at Family Health Centers, which includes routine breastfeeding education and support typically offered to new mothers. This standard care does not include the additional structured support interventions provided in the IMCHB-Based Breastfeeding Support Program.
Первичные конечные точки
- Breastfeeding Self-Efficacy [Срок оценки: Assessed at baseline (32-36 weeks of gestation), and postpartum at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months]
Вторичные конечные точки (2)
- Breastfeeding Attitudes [Срок оценки: Assessed at baseline (32-36 weeks of gestation), and postpartum at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months.]
- Breastfeeding Problems [Срок оценки: Assessed postpartum at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months.]
Критерии участия
Критерии включения
- Primiparous mothers
- Gestational age between 32-40 weeks
- Ability to communicate effectively
- Ownership of a smartphone
- Minimum education level: primary school graduate
Критерии исключения
- Infants with health issues
- Mothers with medical or pregnancy-related complications that hinder breastfeeding (e.g., heart disease, cancer, nephritis, active or untreated tuberculosis, HIV/AIDS, active herpes lesions on the breast, severe malnutrition)
- Participants undergoing infertility treatment with IVF
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Turkey (Türkiye) · 1 центр
- Pamukkale University Family Health Center — Denizli
Публикации
- World Health Organization (WHO). Exclusive breastfeeding for six months best for babies everywhere. Available at: https://www.who.int/news-room/detail/15-01-2024-exclusive-breastfeeding-for-six-months-best-for-babies-everywhere. 2024.
- UNICEF. Breastfeeding. Available at: https://www.unicef.org/nutrition/index_24824.html. 2024.
- Berwick DM, Jacques J. The future of primary care and breastfeeding support. Journal of Health Care Management. 2023; 68(4): 345-354.
- Centers for Disease Control and Prevention (CDC). Breastfeeding Report Card: United States, 2022. Available at: https://www.cdc.gov/breastfeeding/data/reportcard.htm. 2022.
- Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7. PMID 26869575
- Gyamfi AA, Annan RA, Apprey C, Aduku L. Breastfeeding practices and determinants in Ghana: analysis of demographic and health survey data. International Breastfeeding Journal. 2022; 17(1): 32.
- Perez-Escamilla R, Buccini GS, Segura-Pérez S, Piwoz E. Impact of health professionals' training on breastfeeding outcomes. Maternal & Child Nutrition. 2019; 15(S1): e12706. .
- Feenstra MM, Jørgensen JS, Danbjørg DB. Breastfeeding difficulties and support in the early postpartum period: a qualitative study. Journal of Human Lactation. 2018; 34(4): 692-703.
Идентификаторы
NCT: NCT06446362 · 10.186.1.145 111 7.02.2024