Clinical trial NCT06446362: 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding Self-Efficacy Attitude to Health Postpartum Period Primiparity
Keywords: Breastfeeding Self-Efficacy
Breastfeeding Support
Client Health Behavior
Motivational Interviewing
Breastfeeding Attitudes
Breastfeeding Problems
Infant Nutrition
Maternal Confidence
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 45
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled trial (RCT) evaluates the impact of a client health behavior interaction model-based breastfeeding support program on primipara mothers. Participants are randomly assigned to either the intervention group, which receives structured support including educational sessions, motivational interviews, and follow-up via WhatsApp, or the control group, which receives standard care. The study focuses on measuring changes in breastfeeding self-efficacy, attitudes, and problems in the first six months postpartum.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Primiparous mothers
* Gestational age between 32-40 weeks
* Ability to communicate effectively
* Ownership of a smartphone
* Minimum education level: primary school graduate

Exclusion Criteria:

* 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

Primary outcomes:
measure: Breastfeeding Self-Efficacy
timeFrame: 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
Secondary outcomes:
measure: Breastfeeding Attitudes
timeFrame: 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.
measure: Breastfeeding Problems
timeFrame: Assessed postpartum at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months.
Other outcomes:
measure: Exclusive Breastfeeding Rate
timeFrame: Assessed at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months postpartum.
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Family Health Center
state: Pamukkale
Study officials:
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