NCT06723613

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

December 1, 2024

Last Update Submit

March 19, 2025

Conditions

Keywords

Breastfeeding Self-Efficacy ScaleBreastfeeding problemsBreast Milk Quantity

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 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.

Behavioral: Exercise group

Interventions

Exercise groupBEHAVIORAL

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).

Intervention Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Conditions

Breast FeedingBreast Milk Expression

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

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

Locations