Clinical trial NCT05618288: Impact of a Mobile Health Breastfeeding Counseling Intervention for Employed Mothers in Kenya
Official title: Impact of a Mobile Health Breastfeeding Counseling Intervention for Employed Mothers in Kenya
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breastfeeding, Exclusive
Lead sponsor: Wheaton College
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
First posted: 2022-11-16
Enrollment: 284
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to mobile health or in-person breastfeeding counseling
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Mothers over 18 years who are employed in contract-based labor in sectors that include education, business, healthcare, commercial agriculture, tourism/food service.
* 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:

* Mothers of infants with cleft deformities or other abnormalities that interfere with breastfeeding.

Primary outcomes:
measure: Exclusive breastfeeding at 24 weeks
timeFrame: 24 weeks post-partum
Secondary outcomes:
measure: Continued breastfeeding
timeFrame: 36 weeks post partum
measure: Early initiation of breastfeeding
timeFrame: Within 1 hour of childbirth
Other outcomes:
Locations:
Study officials:
affiliation: Wheaton College
name: Scott B Ickes
role: PRINCIPAL_INVESTIGATOR
References: