Exercise Program to Increase Breast Milk
Effect of Exercise Program to Increase Breast Milk on Breastfeeding Self-efficacy, Breastfeeding Success and Breast Milk Quantity: A Randomized Controlled Trial
1 other identifier
interventional
122
1 country
1
Brief Summary
In this study, the effects of an exercise program aimed at increasing breast milk on breastfeeding self-efficacy, breastfeeding success, and breast milk quantity will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2024
CompletedFirst Posted
Study publicly available on registry
December 9, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMarch 20, 2025
March 1, 2025
2 months
December 1, 2024
March 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Comparison of mothers' sociodemographic characteristics with survey before intervention
Mothers' sociodemographic characteristics will be collected through surveys and compared and reported
3 months
Comparison of mothers' Breastfeeding Self-Efficacy Scale averages by groups
Breastfeeding Self-Efficacy Scale will be applied to mothers. Breastfeeding Self-Efficacy Scale is 14-70 points (min-max) and as the score increases, it shows that mothers' breastfeeding self-sufficiency increases.
3 months
Comparison of mothers' LATCH- Breastfeeding Charting system averages by groups
LATCH- Breastfeeding Charting system will be applied to mothers. LATCH- Breastfeeding Charting system is 0-10 points (min-max) and as the score increases, it shows that the mothers' LATCH score increases.
3 months
Comparison of mothers' IMDAT: a tool for assessing the level of maternal milk intake averages by group.
IMDAT will be applied to mothers. IMDAT is 0-10 points (min-max) and the higher the score, the better the intake of breast milk.
3 months
Study Arms (2)
Placebo group
NO INTERVENTIONMothers in the control group will not exercise and will receive routine breastfeeding counseling. In the 8th and 14th weeks after birth, mothers will be subjected to; Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), LATCH- Breastfeeding Charting system, IMDAT: a tool for assessing the level of maternal milk intake scales.
Intervention Group
EXPERIMENTALPrimiparous mothers assigned to the exercise group will attend classes in groups of 8-10. Mothers will be given 1 hour (120 minutes) of exercises to increase breast milk three times a week for 6 weeks. The total training time is 18 hours. Each session will include 60 minutes of warm-up and stretching exercises and 30 minutes of relaxation exercises.
Interventions
Primiparous mothers assigned to the exercise group will attend classes in groups of 8-10. Mothers will be given 1 hour (120 minutes) of exercises to increase breast milk three times a week for 6 weeks. The total training time is 18 hours. Each session will include 60 minutes of warm-up and stretching exercises and 30 minutes of relaxation exercises. Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), LATCH-Breastfeeding Record System, IMDAT: Breast milk intake level assessment tool scales will be applied to mothers before exercise (8th week after birth) and after exercise (14th week).
Eligibility Criteria
You may qualify if:
- Those who are over 18 years old,
- Who gave birth at term pregnancy (38-42 weeks),
- Who have a healthy baby,
- Who are between 8 weeks postpartum.
You may not qualify if:
- Those with diagnosed mental illness (e.g., antidepressants, antianxiety or antipsychotic medications),
- Those with chronic systemic illnesses,
- Those with physical illnesses that may prevent them from exercising,
- Those with any postpartum complications (hemorrhage, postpartum infection, mastitis, thromboembolic disease or postpartum psychiatric disorder).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seyhan Çankaya
Konya, 42250, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator Seyhan Çankaya
Study Record Dates
First Submitted
December 1, 2024
First Posted
December 9, 2024
Study Start
January 1, 2025
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share