Client-Centered Breastfeeding Support: Effects on Primipara Mothers in a Randomized Trial Breastf… (NCT06446362) | Clinical Trial Compass
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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
Turkey (Türkiye)45 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range
15 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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