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

Breastfeeding Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385410
• Other study ID #: 26370
• Status: Completed
• Phase: N/A
• First received: June 28, 2011
• Last updated: October 24, 2013
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 823
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• Peer mother support for continued exclusive breastfeeding
Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum

Locations

Country	Name	City	State
Kenya	Nakuru Provincial General Hospital	Nakuru	Rift Valley

Sponsors (5)

Lead Sponsor	Collaborator
University of Toronto	Egerton University, Emory University, Global Alliance for Improved Nutrition, University of California, Davis

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exclusive breastfeeding		3 months post partum	No