- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06723613
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey, 42250
- Seyhan Çankaya
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Placebo group
Mothers 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. |
|
|
Experimental: Intervention Group
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.
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of mothers' sociodemographic characteristics with survey before intervention
Time Frame: 3 months
|
Mothers' sociodemographic characteristics will be collected through surveys and compared and reported
|
3 months
|
|
Comparison of mothers' Breastfeeding Self-Efficacy Scale averages by groups
Time Frame: 3 months
|
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
Time Frame: 3 months
|
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.
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024/1172
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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