Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05618288

Impact of a Mobile Health Breastfeeding Counseling Intervention for Employed Mothers in Kenya

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mobile Health Breastfeeding Counseling

Behavioral

a phone-based breastfeeding counseling intervention, delivered by labor and delivery nurses, nutritionists, and maternal and child health nurses.

Standard of care breastfeeding counseling

Behavioral

The ongoing antenatal, delivery and postnatal breastfeeding and lactation counseling that is provided by the Naivasha sub-County Referral Hospital.

Primary outcomes

  1. Exclusive breastfeeding at 24 weeks

    Time frame: 24 weeks post-partum

    The proportion of mothers who feed only breastmilk to their infants, without other liquids, formula or semi-solid or solid food.

Secondary outcomes

  1. Continued breastfeeding

    Time frame: 36 weeks post partum

    Any breastfeeding in the past 24 hours

  2. Early initiation of breastfeeding

    Time frame: Within 1 hour of childbirth

    Breastfeeding within 1 hour of childbirth

Study contacts

Contact information is provided by the study sponsor or research team.

Joyceline Kinyua, MPH

CONTACT

[email protected]

+254710289926

Virginia Shaffer, MA

CONTACT

[email protected]

1-630-752-5623

Sponsors and collaborators

Lead sponsor

Wheaton College

Other

Collaborators

  • Kenya Medical Research Institute

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 16, 2022
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.