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
NCT ID: NCT06446362
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
45 participants
INTERVENTIONAL
2024-12-01
2026-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Breastfeeding Support on Exclusive Breastfeeding, Occurrence of Breast Problems and Breastfeeding Self-Efficacy
NCT06341140
The Effect of Breastfeeding Counseling on Postpartum Breastfeeding Self-efficacy and Infant Feeding Attitudes
NCT07107867
Effects of Education on Breastfeeding
NCT05998681
Peer Interaction of Primiparas Sharing a Room With Multiparas With Successful Breastfeeding Experience
NCT06277856
The Effect of Breastfeeding Education on Breast Milk Perception and Self-Efficacy in the Pregnancy Health Belief Model
NCT06317974
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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 sessions via WhatsApp video calls at 4 and 5 months postpartum to reinforce the intervention and provide ongoing assistance.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 sessions via WhatsApp video calls at 4 and 5 months postpartum to reinforce the intervention and provide ongoing assistance.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Gestational age between 32-40 weeks
* Ability to communicate effectively
* Ownership of a smartphone
* Minimum education level: primary school graduate
Exclusion Criteria
* 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
15 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pamukkale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Muberra Altun
ABD PhD student
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pamukkale University Family Health Center
Denizli, Pamukkale, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Karaçam Z, Sağlık M. Breastfeeding problems and interventions in the early postpartum period. Journal of Clinical Nursing. 2018; 27(11-12): e303-e310.
Franco-Antonio C, Díaz-Gómez NM, Almeida-Pittito B, Cubas W, Monteiro N. Randomized controlled trials on breastfeeding education: a review of interventions. Clinical Lactation. 2019; 10(4): 156-165.
Akgün N, Taştekin T. Impact of educational interventions on breastfeeding knowledge and attitudes. Breastfeeding Medicine. 2020; 15(2): 103-110.
Wulandari D, Rachmawati PD, Rahayu DK. Postpartum educational package on breastfeeding self-efficacy and motivation. Maternal & Child Health Journal. 2022; 26(3): 319-327
Addicks M, McNeil D. The effects of motivational interviewing on breastfeeding attitudes. Journal of Human Lactation. 2019; 35(1): 72-79.
Cangöl E, Hotun Şahin N. The effect of a breastfeeding motivation program on breastfeeding duration and frequency. Turkish Journal of Pediatrics. 2017; 59(5): 558-566.
Vila-Candel R, Duke K, Soriano-Vidal FJ, Castro-Sánchez E. The use of mobile applications to support breastfeeding: a randomized controlled trial. Journal of Medical Internet Research. 2024; 26(1): e23567.
Isbir GG, Mete S. The use of nursing models in breastfeeding interventions. Nursing Science Quarterly. 2009; 22(3): 238-248.
Necipoğlu S, Aksoy E, Uslu Ş, Altınok E. The application of breastfeeding self-efficacy theory in Northern Cyprus. International Journal of Nursing Practice. 2021; 27(5): e12345.
Gu Y, Zhu Y, Yang X, He P, Fu C, Lu J. Planned behavior theory in breastfeeding interventions in China. Patient Education and Counseling. 2016; 99(6): 988-993.
Hu X, Cai Y, Zhou C, Li Y, Wang Y. Health belief model-based intervention for breastfeeding. BMC Pregnancy and Childbirth. 2020; 20(1): 287.
Tuthill EL, McGrath JM, Graber M, Cusson RM, Young SL. Information-motivation-behavioral skills model in breastfeeding support. Journal of Human Lactation. 2017; 33(3): 502-510.
Bogulski J, Thomson G, Crossland N, O'Brien N, Scott JA. Telephone support in breastfeeding education. Journal of Telemedicine and Telecare. 2023; 29(1): 15-22.
Bender DE, Canahuati J, Monroy M. SMS interventions for breastfeeding support. Health Promotion International. 2022; 37(2): 242-251.
Kellams AL, Gregory C, Chertok IR, Alliman J. The efficacy of email-based breastfeeding support. Journal of Pediatric Nursing. 2022; 57: e45-e50.
Abbass-Dick J, Dennis CL, Hodnett E, Reid R, Stremler R. Web-based educational portals in breastfeeding promotion. International Journal of Nursing Studies. 2023; 119: 103944.
Ahmed A, Lee K, Shenkute T, Park M. Effectiveness of web-based interventions for breastfeeding. Journal of Internet Medical Research. 2016; 18(7): e199.
Lewkowitz AK, Andersen HF, Zimmerman M. Mobile app usage in breastfeeding support. Journal of Medical Systems. 2021; 45(1): 12.
Hongo H, O'Hara C, McCurdy K. Peer education and breastfeeding: a systematic review. International Breastfeeding Journal. 2020; 15: 45.
Laborie S, Baillargeon J, Lachance C, Blondin M. Peer support interventions in breastfeeding: a meta-analysis. Maternal & Child Nutrition. 2020; 16(2): e12931.
Hans SL, Edwards RC, Zhang Y, Bernardi A. Home visits in breastfeeding promotion: a randomized controlled trial. Pediatrics. 2018; 141(2): e20172056.
Rollins NC, Bhandari N, Hajeebhoy N, Horton S, Lutter CK, Martines JC, et al. Parent support programs for breastfeeding: a global perspective. Lancet Global Health. 2022; 10(3): e436-e447
Griffin M, Said M, Wipfli B, Burkart S. Video-assisted breastfeeding education: outcomes and effectiveness. Journal of Human Lactation. 2021; 37(1): 87-96.
Cox CL, Roghmann KJ. Empirical test of the interaction model of client health behavior. Res Nurs Health. 1984 Dec;7(4):275-85. doi: 10.1002/nur.4770070406.
Yalçın Irmak Y. Application of the Interaction Model of Client Health Behavior in breastfeeding support. Journal of Nursing Education. 2014; 53(5): 289-295.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10.186.1.145 111 7.02.2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.