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

This study is ongoing, but not recruiting participants.

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: January 16, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention
Breastfeeding	Behavioral: Peer mother support for continued exclusive breastfeeding

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
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.

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:

exclusive breastfeeding [ Time Frame: 3 months post partum ] [ Designated as safety issue: No ]

Estimated Enrollment:	905
Study Start Date:	June 2011
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Cell phone base peer support	Behavioral: Peer mother support for continued exclusive breastfeeding Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum
Active Comparator: Group based peer support	Behavioral: Peer mother support for continued exclusive breastfeeding Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385410

Locations

Kenya
Nakuru Provincial General Hospital
Nakuru, Rift Valley, Kenya

Sponsors and Collaborators

University of Toronto

Egerton University

University of California, Davis

Global Alliance for Improved Nutrition

Emory University

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

More Information

No publications provided

Responsible Party:	Daniel Sellen, Professor, University of Toronto
ClinicalTrials.gov Identifier:	NCT01385410 History of Changes
Other Study ID Numbers:	26370
Study First Received:	June 28, 2011
Last Updated:	January 16, 2013
Health Authority:	Canada: Canadian Institutes of Health Research

Keywords provided by University of Toronto:

breastfeeding exclusively

ClinicalTrials.gov processed this record on May 19, 2013

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