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Breastfeeding Self-Efficacy Attitude to Health Postpartum Period PrimiparityNCT06446362

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

A study testing IMCHB-Based Breastfeeding Support Program and Standard Breastfeeding Education in people with Breastfeeding Self-Efficacy Attitude to Health Postpartum Period Primiparity, run by Pamukkale University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 35 years, women onlyHealthy volunteers can take part
What is being tested?
IMCHB-Based Breastfeeding Support Program and Standard Breastfeeding Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2024to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting

  • Pamukkale University Family Health Center

    Denizli, Pamukkale, 20100

    Muberra NA Altun, PhD, +905366407849, muberraaltun@gmail.com

    Ilgun NA Ozen Cinar, PhD, +905323556791, iocinar@pau.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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 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:

Read more
  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.
Read the 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.

Being tested
IMCHB-Based Breastfeeding Support Program, Standard Breastfeeding Education
Keywords
Breastfeeding Self-Efficacy, Breastfeeding Support, Client Health Behavior, Motivational Interviewing, Breastfeeding Attitudes, Breastfeeding Problems, Infant Nutrition, Maternal Confidence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMCHB-Based Breastfeeding Support ProgramBehavioural

    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 EducationBehavioural

    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.

Study groups in NCT06446362
Study groupRoleWhat they receive
IMCHB-Based Support ProgramExperimentalParticipants 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.
Receives: Behavioral: IMCHB-Based Breastfeeding Support Program
Standard CareActive comparatorParticipants 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.
Receives: Behavioral: Standard Breastfeeding Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Breastfeeding Attitudes

    Assessment of mothers' attitudes towards breastfeeding using the Iowa Infant Feeding Attitude Scale (IIFAS). The scale includes 17 items rated on a 5-point Likert scale, with total scores ranging from 17 to 85. Higher scores indicate more positive attitudes toward breastfeeding, meaning a better outcome.

    Measured: 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.

  2. Breastfeeding Problems

    Measurement of the frequency and severity of breastfeeding problems using the Breastfeeding Experience Scale (BES). This scale evaluates issues such as latch difficulties, pain, and milk supply concerns. Scores range from 0 to 100, with higher scores indicating more severe problems, meaning a worse outcome.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06446362
Sponsor's protocol ID
10.186.1.145 111 7.02.2024
Status last verified
Nov 2024
First submitted
1 Jun 2024
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD that underlie the results in a publication will be shared.

Publications

  • 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.

    PubMed 26869575

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing IMCHB-Based Breastfeeding Support Program and Standard Breastfeeding Education in people with Breastfeeding Self-Efficacy Attitude to Health Postpartum Period Primiparity, run by Pamukkale University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breastfeeding Self-Efficacy (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06446362, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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