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

NCT06446362 | Recruiting

• 1 other identifier: 10.186.1.145 111 7.02.2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 1.How does the program influence mothers' self-efficacy in breastfeeding?
2. 2.What impact does the program have on mothers' attitudes towards breastfeeding and the problems they encounter?
3. 3.Receive breastfeeding support through an interactive health behavior model.
4. 4.Participate in assessments of their breastfeeding self-efficacy and attitudes at designated intervals throughout the study duration.

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

Outcome Measures

Primary Outcomes (1)

• Breastfeeding Self-Efficacy

  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.

  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 (2)

• 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.

• Breastfeeding Problems

  Assessed postpartum at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months.

Other Outcomes (1)

• Exclusive Breastfeeding Rate

  Assessed at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months postpartum.

Study Arms (2)

IMCHB-Based Support Program

EXPERIMENTAL

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.

Behavioral: IMCHB-Based Breastfeeding Support Program

Standard Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Breastfeeding Education

Interventions

IMCHB-Based Breastfeeding Support Program BEHAVIORAL

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 sessions via WhatsApp video calls at 4 and 5 months postpartum to reinforce the intervention and provide ongoing assistance.

IMCHB-Based Support Program

Standard Breastfeeding Education BEHAVIORAL

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.

Standard Care

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Family Health Center

Denizli, Pamukkale, 20100, Turkey (Türkiye)

RECRUITING

Related Publications (33)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ABD PhD student

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 6, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication and available for 5 years.
• Access Criteria: PD will be shared with researchers who provide a methodologically sound proposal. Proposals will be reviewed by an independent review committee. Data will be available for analyses aimed at achieving the objectives in the approved proposal. Requests for IPD should be directed to the study principal investigator.

Locations

TU (1)