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

NCT ID: NCT01385410

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

823 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Breastfeeding

Keywords

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breastfeeding exclusively

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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CPS, cell phone based peer support

Cell phone base peer mother support for continued exclusive breastfeeding

Group Type ACTIVE_COMPARATOR

Peer mother support for continued exclusive breastfeeding

Intervention Type BEHAVIORAL

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

PSG, group meeting based peer support

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

Group Type ACTIVE_COMPARATOR

Peer mother support for continued exclusive breastfeeding

Intervention Type BEHAVIORAL

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

Control

Current standard of care and support (national health system)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Peer mother support for continued exclusive breastfeeding

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Egerton University

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role collaborator

Global Alliance for Improved Nutrition

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Daniel Sellen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Sellen, PhD

Role: STUDY_DIRECTOR

University of Toronto

Elizabeth Kamau-Mbuthia, PhD

Role: PRINCIPAL_INVESTIGATOR

Egerton University

Samwel Mbugua, MSc

Role: PRINCIPAL_INVESTIGATOR

Egerton University

Aimee Webb Girard

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Nakuru Provincial General Hospital

Nakuru, Rift Valley, Kenya

Site Status

Countries

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Kenya

Other Identifiers

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26370

Identifier Type: -

Identifier Source: org_study_id