Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446362
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-01
Brief Title:
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
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None