Impact of a Mobile Health Breastfeeding Counseling Intervention for Employed Mothers in Kenya
NCT ID: NCT05618288
Last Updated: 2022-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
284 participants
INTERVENTIONAL
2025-07-01
2028-06-30
Brief Summary
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Detailed Description
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Mobile health (mHealth) describes a range of wireless technologies and techniques that seek to increase patient access to and interaction with preventive health services. mHealth technologies hold untapped potential to support healthcare workers' training and counseling approaches to support lactation for working mothers, especially when collaboratively developed with end users.
This study will develop and test the feasibility of an mHealth intervention to improve support counseling for breastfeeding at a large sub-county referral hospital in Naivasha, Kenya. The primary objective of this proposal is to develop mHealth technology to equip and support healthcare worker breastfeeding counseling, and implement and evaluate its impact. We hypothesize that a culturally sensitive and technologically appropriate mHealth counseling intervention will improve EBF rates among infants of employed mothers. This study will be conducted in three aims:
Before the clinical trial phase of the study begins, we will employ a human-centered design approach to iteratively develop and test the feasibility of an mHealth intervention to support breastfeeding counseling for employed mothers.
After developing the technology, we will evaluate the impact of the mHealth breastfeeding counseling intervention on the outcomes of EBF, child morbidity, and worker presenteeism.
The overarching goal of this proposal is to develop an mHealth intervention that can successfully support continued lactation and BF for employed mothers across various sectors and be disseminated at a national scale in Kenya and other LMIC contexts where employed mothers face unique challenges to practicing EBF while maintaining employment.
Mothers will be recruited in the third trimester of pregnancy and followed through 9-months postpartum. 284 mothers will be randomly assigned to an mHealth counseling intervention or the Standard of Care (in person counseling at the Naivasha Sub-County Referral Hospital). there will be 142 mothers in each intervention arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard of Care
Standard of care breastfeeding counseling. The ongoing antenatal, delivery and postnatal breastfeeding and lactation counseling that is provided by the Naivasha sub-County Referral Hospital.
Standard of care breastfeeding counseling
The ongoing antenatal, delivery and postnatal breastfeeding and lactation counseling that is provided by the Naivasha sub-County Referral Hospital.
mobile Health (mHealth)
Simple messaging service counseling intervention with healthcare providers. This arm will involve two-way messaging with healthcare providers Unstructured Supplementary Service Data application that provides session-based interaction with breastfeeding and lactation support content.
mobile Health Breastfeeding Counseling
a phone-based breastfeeding counseling intervention, delivered by labor and delivery nurses, nutritionists, and maternal and child health nurses.
Interventions
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mobile Health Breastfeeding Counseling
a phone-based breastfeeding counseling intervention, delivered by labor and delivery nurses, nutritionists, and maternal and child health nurses.
Standard of care breastfeeding counseling
The ongoing antenatal, delivery and postnatal breastfeeding and lactation counseling that is provided by the Naivasha sub-County Referral Hospital.
Eligibility Criteria
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Inclusion Criteria
* Mothers must reside in the greater Naivasha, Kenya area and receive maternal and child health care at the Naivasha sub-County Referral Hospital.
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Kenya Medical Research Institute
OTHER
Wheaton College
OTHER
Responsible Party
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Principal Investigators
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Scott B Ickes
Role: PRINCIPAL_INVESTIGATOR
Wheaton College
Central Contacts
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Other Identifiers
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ICKES221114
Identifier Type: -
Identifier Source: org_study_id
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