Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05618288 |
| Other study ID # |
ICKES221114 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2025 |
| Est. completion date |
June 30, 2028 |
Study information
| Verified date |
November 2022 |
| Source |
Wheaton College |
| Contact |
Virginia Shaffer, MA |
| Phone |
1-630-752-5623 |
| Email |
virginia.shaffer[@]wheaton.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Exclusive breastfeeding (EBF) is critical for child survival, growth, and maternal health;
however, over half of mothers in low and middle-income countries (LMIC). Mobile health
(mHealth) describes a range of wireless technologies and techniques that seek to increase
patient access to and interaction with preventive health services. 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.
Description:
Exclusive breastfeeding (EBF) is critical for child survival, growth, and maternal health;
however, over half of mothers in low and middle-income countries (LMICs) do not practice EBF
through the recommended six months of infancy. Maternal employment is a significant risk
factor for early cessation of EBF in LMICs. Policies in Kenya seek to support working mothers
to continue practicing EBF after a nationally mandated 12-week maternity leave. However, the
implementation of this policy is limited, and only 17% of formally employed mothers practice
EBF through the recommended six months in Naivasha, Kenya, where a high proportion of mothers
are employed in commercial agriculture and other low-wage industries.
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.
