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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Breastfeeding Self-Efficacy
研究概览
简要总结
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:
- How does the program influence mothers' self-efficacy in breastfeeding?
- What impact does the program have on mothers' attitudes towards breastfeeding and the problems they encounter?
Participants will:
- Receive breastfeeding support through an interactive health behavior model.
- 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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study employs a double-blind masking approach. Participants, care providers, and investigators are blinded to intervention allocation. The outcomes assessor, responsible for evaluating primary and secondary outcomes, is also blinded to group assignments. This minimizes bias and ensures objective assessment of breastfeeding self-efficacy, attitudes, and problems. Masking is maintained through coded intervention materials and separate teams for intervention delivery and outcome assessment.
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous mothers
- •Gestational age between 32-40 weeks
- •Ability to communicate effectively
- •Ownership of a smartphone
- •Minimum education level: primary school graduate
排除标准
- •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
研究组 & 干预措施
IMCHB-Based Support Program
Participants in this arm will receive a structured breastfeeding support program based on the Interaction Model of Client Health Behavior (IMCHB). This program includes:
Educational Sessions: Conducted during the last trimester of pregnancy. Motivational Interviews: Conducted face-to-face postpartum at 1-3 days, 15 days, 30 days, 45 days, and 60 days.
Follow-Up Support: Two additional follow-up sessions via WhatsApp video calls at 4 and 5 months postpartum.
干预措施: IMCHB-Based Breastfeeding Support Program (Behavioral)
Standard Care
Participants in this arm will receive the standard care provided at Family Health Centers, which includes routine breastfeeding education and support. This standard care does not include the structured and additional support interventions provided to the experimental group.
干预措施: Standard Breastfeeding Education (Behavioral)
结局指标
主要结局
Breastfeeding Self-Efficacy
时间窗: 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
The measurement of mothers' confidence in their ability to breastfeed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). The scale consists of 14 items scored on a 5-point Likert scale, where 1 represents "not at all confident" and 5 represents "very confident." Total scores range from 14 to 70, with higher scores indicating greater self-efficacy in breastfeeding, meaning a better outcome.
次要结局
- Breastfeeding Problems(Assessed postpartum at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months.)
- Breastfeeding Attitudes(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.)
研究者
Muberra Altun
ABD PhD student
Pamukkale University