Breastfeeding, ExclusiveNCT05618288
Impact of a Mobile Health Breastfeeding Counseling Intervention for Employed Mothers in Kenya
A study testing mobile Health Breastfeeding Counseling in people with Breastfeeding, Exclusive, run by Wheaton College.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive
- What is being tested?
- mobile Health Breastfeeding Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mothers of infants with cleft deformities or other abnormalities that interfere with breastfeeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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 (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.
Read the 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.
- Conditions
- Breastfeeding, Exclusive
- Being tested
- mobile Health Breastfeeding Counseling, Standard of care breastfeeding counseling
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile Health Breastfeeding CounselingBehavioural
a phone-based breastfeeding counseling intervention, delivered by labor and delivery nurses, nutritionists, and maternal and child health nurses.
Standard of care breastfeeding counselingBehavioural
The ongoing antenatal, delivery and postnatal breastfeeding and lactation counseling that is provided by the Naivasha sub-County Referral Hospital.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: mobile Health Breastfeeding Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks post-partum
Secondary outcomes (2)
Continued breastfeeding
Any breastfeeding in the past 24 hours
Measured: 36 weeks post partum
Early initiation of breastfeeding
Breastfeeding within 1 hour of childbirth
Measured: Within 1 hour of childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to mobile health or in-person breastfeeding counseling
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wheaton College
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Scott B Ickes, Principal investigator, Wheaton College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618288
- Sponsor's protocol ID
- ICKES221114
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Mobile Health Breastfeeding Counseling Intervention for Employed Mothers in Kenya
- ClinicalTrials.gov ID
- NCT05618288
- Acronym / sponsor ID
- ICKES221114
- Conditions
- Breastfeeding, Exclusive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Wheaton CollegeUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to mobile health or in-person breastfeeding counseling
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Standard of care breastfeeding counselingStandard 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) | Experimental | Behavioral: mobile Health Breastfeeding CounselingSimple 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Mothers of infants with cleft deformities or other abnormalities that interfere with breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile Health Breastfeeding Counselinga phone-based breastfeeding counseling intervention, delivered by labor and delivery nurses, nutritionists, and maternal and child health nurses. | Behavioural | mobile Health (mHealth) |
| Standard of care breastfeeding counselingThe ongoing antenatal, delivery and postnatal breastfeeding and lactation counseling that is provided by the Naivasha sub-County Referral Hospital. | Behavioural | Standard of Care |
Primary outcome
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.
2 secondary outcomes
Continued breastfeeding
Time frame: 36 weeks post partum
Early initiation of breastfeeding
Time frame: Within 1 hour of childbirth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott B Ickes principal investigator
Wheaton College
Questions about this trial
What is this clinical trial studying?
A study testing mobile Health Breastfeeding Counseling in people with Breastfeeding, Exclusive, run by Wheaton College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginia Shaffer, MA (1-630-752-5623, virginia.shaffer@wheaton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding at 24 weeks (time frame: 24 weeks post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.