NCT05618288

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Jul 2025

Typical duration for not_applicable

Status
not yet recruiting

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

Study Progress28%
Jul 2025Jun 2028

First Submitted

Initial submission to the registry

November 15, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

2.6 years

First QC Date

November 15, 2022

Last Update Submit

November 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Exclusive breastfeeding at 24 weeks

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

    24 weeks post-partum

Secondary Outcomes (2)

  • Continued breastfeeding

    36 weeks post partum

  • Early initiation of breastfeeding

    Within 1 hour of childbirth

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Standard of care breastfeeding counseling

mobile Health (mHealth)

EXPERIMENTAL

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.

Behavioral: mobile Health Breastfeeding Counseling

Interventions

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

mobile Health (mHealth)

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

Standard of Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Scott B Ickes

    Wheaton College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyceline Kinyua, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomization to mobile health or in-person breastfeeding counseling
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 16, 2022

Study Start

July 1, 2025

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Only de-identified data will be shared with other researchers. This will include maternal research identification number, education level, martial status, parity, type of employment, child morbidity and breastfeeding status (at 0, 6, 14, 24, and 36 weeks weeks).

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
2 months after the primary data analysis is complete.
Access Criteria
Permission of the principal investigator.