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Providing Peer Mother Support Through Cell Phone and Group Meetings to Increase Exclusive Breastfeeding in Kenya

This study has been completed.
Sponsor:
Collaborators:
Egerton University
University of California, Davis
Global Alliance for Improved Nutrition
Emory University
Information provided by (Responsible Party):
Daniel Sellen, University of Toronto
ClinicalTrials.gov Identifier:
NCT01385410
First received: June 28, 2011
Last updated: October 24, 2013
Last verified: October 2013

June 28, 2011
October 24, 2013
June 2011
October 2012   (final data collection date for primary outcome measure)
exclusive breastfeeding [ Time Frame: 3 months post partum ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01385410 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

This behavioural support intervention trial will investigate the potential to increase exclusive breastfeeding rates in an urban Kenyan community through peer mother support delivered either by cell phone or through group meetings. It will follow a cohort of more than 800 women attending antenatal care at a large public hospital, and compare indicators of breastfeeding and infant and maternal health between groups receiving one or other type of peer mother support. The main part of the study will test the primary hypothesis that peer group and cell phone based support can both increase rates of EBF at 3 months by 20% relative to a control group.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Breastfeeding
Behavioral: Peer mother support for continued exclusive breastfeeding
Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum
  • Active Comparator: CPS, cell phone based peer support
    Cell phone base peer mother support for continued exclusive breastfeeding
    Intervention: Behavioral: Peer mother support for continued exclusive breastfeeding
  • Active Comparator: PSG, group meeting based peer support
    Group based peer Cell phone base peer mother support for continued exclusive breastfeeding
    Intervention: Behavioral: Peer mother support for continued exclusive breastfeeding
  • No Intervention: Control
    Current standard of care and support (national health system)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
823
January 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria for mothers:

  1. attending antenatal care services at the target facility;
  2. confirmed pregnant by a health care worker;
  3. 24-32 weeks gestation at enrollment;
  4. competency in KiSwahili or English (or both)
  5. current resident of Nakuru municipality and expecting to reside there for the next 6 months;
  6. intend to breastfeed their newborn;
  7. self-report of any condition preventing the subject from breastfeeding (excluding HIV infection)
  8. no history of mental illness
  9. either HIV-negative on test result OR referred bto PMTCT services following verified positive HIV-test results
  10. willing to participate in study described in IC forms
  11. 18-45 years of age
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01385410
26370
No
Daniel Sellen, University of Toronto
University of Toronto
  • Egerton University
  • University of California, Davis
  • Global Alliance for Improved Nutrition
  • Emory University
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
University of Toronto
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP