- 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breastfeeding
-
Uludag UniversityCompletedVirtual Reality | Breastfeeding Education | Breastfeeding Duration | Breastfeeding Self-Efficacy | Metaverse | Breastfeeding Motivation | Digital Museum | Breastfeeding Problems AssessmentTurkey (Türkiye)
-
Marmara UniversityNot yet recruitingBreastfeeding | Breastfeeding Support
-
Halic UniversityCompletedBreastfeeding | Breastfeeding, ExclusiveTurkey
-
University of Ontario Institute of TechnologyDurham Region Health DepartmentUnknown
-
University of California, DavisUniversity of California, San Francisco; Public Hospital Roatan, HondurasCompletedBreastfeeding | Breastfeeding, ExclusiveHonduras
-
T.C. ORDU ÜNİVERSİTESİCompletedBreastfeeding Education | Breastfeeding Attitude | Breastfeeding Self-EfficacyTurkey
-
Semmelweis UniversityNot yet recruitingLactation | Breastfeeding | Breastfeeding Mothers | Breastfeeding Education | Lactating Mother
-
Fundacion Profesor Novoa SantosNot yet recruitingGrowth & Development | Breastfeeding, Exclusive | Breastfeeding Rate | Breastfeeding Outcomes | Breastfeeding Duration | Breastfeeding After Discharge From Hospital Following Childbirth, Yes/no | Breastfeeding Attitude | Breastfeeding Support System | Breastfeeding Consultancy Training | Breastfeeding...Spain
-
Celal Bayar UniversityManisa Celal Bayar UniversityCompletedBreastfeeding | Breastfeeding, ExclusiveTurkey
-
Benten Technologies, Inc.National Institute on Minority Health and Health Disparities (NIMHD); George... and other collaboratorsEnrolling by invitationBreastfeeding | Exclusive BreastfeedingUnited States
Clinical Trials on Peer mother support for continued exclusive breastfeeding
-
Makerere UniversityUniversity of Bergen; Centre MurazUnknownMalnutrition | Neurologic Deficits | Poor Performance Status | Infections, Hospital | Mixed Behavior and Emotional DisorderUganda
-
Centre For International HealthUppsala University; University of Bergen; Makerere University; Université Montpellier and other collaboratorsCompletedDiarrheaUganda, Burkina Faso, South Africa, Zambia
-
Boston Medical CenterNational Institutes of Health (NIH); United States Agency for International...Completed
-
Hospices Civils de LyonCompletedInfant PrematureFrance, Switzerland, Belgium
-
University of TorontoCanadian Institutes of Health Research (CIHR)Completed
-
University of TurkuCompletedBreast Feeding | Infant, Premature
-
Hospices Civils de LyonRecruitingBreastfeeding | Health Disparities | Breastfeeding Support | Health InequalitiesFrance
-
University of OxfordNot yet recruitingBreastfeeding, Exclusive | Malnutrition, Infant
-
Dokuz Eylul UniversityCompletedInfantile Colic | Self Efficacy | Jaundice, Neonatal | Breastfeeding, ExclusiveTurkey
-
Mahidol UniversityInternational Centre for Diarrhoeal Disease Research, Bangladesh; International... and other collaboratorsCompletedHuman Milk | Exclusive Breastfeeding | Breast Milk