NCT01385410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
823

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

June 28, 2011

Last Update Submit

October 24, 2013

Conditions

Keywords

breastfeeding exclusively

Outcome Measures

Primary Outcomes (1)

  • exclusive breastfeeding

    3 months post partum

Study Arms (3)

CPS, cell phone based peer support

ACTIVE COMPARATOR

Cell phone base peer mother support for continued exclusive breastfeeding

Behavioral: Peer mother support for continued exclusive breastfeeding

PSG, group meeting based peer support

ACTIVE COMPARATOR

Group based peer Cell phone base peer mother support for continued exclusive breastfeeding

Behavioral: Peer mother support for continued exclusive breastfeeding

Control

NO INTERVENTION

Current standard of care and support (national health system)

Interventions

Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum

CPS, cell phone based peer supportPSG, group meeting based peer support

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • attending antenatal care services at the target facility;
  • confirmed pregnant by a health care worker;
  • 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
  • years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nakuru Provincial General Hospital

Nakuru, Rift Valley, Kenya

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Daniel Sellen, PhD

    University of Toronto

    STUDY DIRECTOR
  • Elizabeth Kamau-Mbuthia, PhD

    Egerton University

    PRINCIPAL INVESTIGATOR
  • Samwel Mbugua, MSc

    Egerton University

    PRINCIPAL INVESTIGATOR
  • Aimee Webb Girard

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 30, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations