- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385410
Providing Peer Mother Support Through Cell Phone and Group Meetings to Increase Exclusive Breastfeeding in Kenya
Effectiveness of a Baby-friendly Hospital Based Mothers' Support Group, and a Cell-phone Based Peer Support Program in Supporting Exclusive Breastfeeding in an Urban Kenyan Community.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The general objective was to assess whether participation from late pregnancy through to 3 months postpartum in bi-weekly cell phone based peer support (CPS) or monthly peer-led support groups (PSG) can increase adoption and duration of EBF amongst low-income women in Kenya served by a nationalized BFHI certified hospital above benchmarks achieved with current approaches and standard of care by existing facility-based support (SOC).
The study aimed to reach the following specific objectives related to message delivery on EBF:
assess the feasibility of two innovative approaches (CPS and PSG) to deliver extended postnatal peer support for EBF by women in an urban, low-income country setting; compare the effectiveness of these two innovative approaches to existing facility-based support; and compare the relative effectiveness of each type of peer support intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rift Valley
-
Nakuru, Rift Valley, Kenya
- Nakuru Provincial General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for mothers:
- attending antenatal care services at the target facility;
- confirmed pregnant by a health care worker;
- 24-32 weeks gestation at enrollment;
- competency in KiSwahili or English (or both)
- current resident of Nakuru municipality and expecting to reside there for the next 6 months;
- intend to breastfeed their newborn;
- self-report of any condition preventing the subject from breastfeeding (excluding HIV infection)
- no history of mental illness
- either HIV-negative on test result OR referred bto PMTCT services following verified positive HIV-test results
- willing to participate in study described in IC forms
- 18-45 years of age
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: CPS, cell phone based peer support
Cell phone base peer mother support for continued exclusive breastfeeding
|
Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum
|
|
Active Comparator: PSG, group meeting based peer support
Group based peer Cell phone base peer mother support for continued exclusive breastfeeding
|
Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum
|
|
No Intervention: Control
Current standard of care and support (national health system)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
exclusive breastfeeding
Time Frame: 3 months post partum
|
3 months post partum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Daniel Sellen, PhD, University of Toronto
- Principal Investigator: Elizabeth Kamau-Mbuthia, PhD, Egerton University
- Principal Investigator: Samwel Mbugua, MSc, Egerton University
- Principal Investigator: Aimee Webb Girard, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 26370
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