Clinical trial NCT01385410: Providing Peer Mother Support Through Cell Phone and Group Meetings to Increase Exclusive Breastfeeding in Kenya
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: breastfeeding exclusively
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Egerton University
name: University of California, Davis
name: Global Alliance for Improved Nutrition
name: Emory University
First posted: 2011-06-30
Enrollment: 823
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: exclusive breastfeeding
timeFrame: 3 months post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Nakuru
country: Kenya
facility: Nakuru Provincial General Hospital
state: Rift Valley
Study officials:
affiliation: University of Toronto
name: Daniel Sellen, PhD
role: STUDY_DIRECTOR
affiliation: Egerton University
name: Elizabeth Kamau-Mbuthia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Egerton University
name: Samwel Mbugua, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Aimee Webb Girard
role: PRINCIPAL_INVESTIGATOR
References: