Maternal BehaviorNCT06723613
Exercise Program to Increase Breast Milk
A study testing Exercise group in people with Maternal Behavior and Breastfeeding, Exclusive, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Behavior, Breastfeeding, Exclusive, Breast Milk Expression
- What is being tested?
- Exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise Program to Increase Breast Milk on Breastfeeding Self-efficacy, Breastfeeding Success and Breast Milk Quantity: A Randomized Controlled Trial
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.
Read the detailed description
The research is a randomized controlled trial. The research will be conducted with 122 mothers who are in their 8th week postpartum and have healthy babies. Mothers in the exercise group will be given 1 hour (60 minutes) of exercise to increase breast milk three times a week for 6 weeks. The control group will be given routine breastfeeding education. Data will be collected using a sociodemographic form, Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), LATCH- Breastfeeding Charting system, IMDAT: a tool for assessing the level of maternal milk intake scale.
- Being tested
- Exercise group
- Keywords
- Breastfeeding Self-Efficacy Scale, Breastfeeding problems, Breast Milk Quantity
- Medical subject headings
- Breast Feeding, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | No intervention | 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. |
| Intervention Group | Experimental | 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. Receives: Behavioral: Exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mothers' sociodemographic characteristics with survey before intervention
Mothers' sociodemographic characteristics will be collected through surveys and compared and reported
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2025
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan Çankaya, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723613
- Sponsor's protocol ID
- 2024/1172
- Status last verified
- Mar 2025
- First submitted
- 1 Dec 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aslantas BN, Cankaya S. The effect of an exercise program to enhance lactation on breastfeeding self-efficacy, breastfeeding success, and the amount of breast milk received by the infant: a randomized controlled trial. Postgrad Med. 2026 May;138(4):466-478. doi: 10.1080/00325481.2026.2672182. Epub 2026 May 12.
PubMed 42117637
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Program to Increase Breast Milk on Breastfeeding Self-efficacy, Breastfeeding Success and Breast Milk Quantity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06723613
- Acronym / sponsor ID
- 2024/1172
- Keywords
- Breastfeeding Self-Efficacy Scale, Breastfeeding problems, Breast Milk Quantity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research is a randomized controlled trial. The research will be conducted with 122 mothers who are in their 8th week postpartum and have healthy babies. Mothers in the exercise group will be given 1 hour (60 minutes) of exercise to increase breast milk three times a week for 6 weeks. The control group will be given routine breastfeeding education. Data will be collected using a sociodemographic form, Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), LATCH- Breastfeeding Charting system, IMDAT: a tool for assessing the level of maternal milk intake scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | No intervention | –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. |
| Intervention Group | Experimental | Behavioral: Exercise groupPrimiparous 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise groupPrimiparous 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). | Behavioural | Intervention Group |
Primary outcome
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 42117637Aslantas BN, Cankaya S. The effect of an exercise program to enhance lactation on breastfeeding self-efficacy, breastfeeding success, and the amount of breast milk received by the infant: a randomized controlled trial. Postgrad Med. 2026 May;138(4):466-478. doi: 10.1080/00325481.2026.2672182. Epub 2026 May 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in people with Maternal Behavior and Breastfeeding, Exclusive, run by Selcuk 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 20 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of mothers' sociodemographic characteristics with survey before intervention (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT06723613, which also lists 1 linked publication.
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 20 Mar 2025; AzTrials last refreshed its copy on 28 Oct 2026.