NCT02800564

Brief Summary

Optimal infant and young child feeding practices are largely inadequate in rural and poor households in Ghana. Child welfare clinics (CWCs) focus on immunization, supplementation, and growth monitoring and promotion (GMP) activities among infants and young children (IYC). An essential component of GMP activities is to counsel mothers to practice optimal IYC feeding and health practices, but most of the time this is completely missing or not specific enough to be effective. This study will test the effect of a mass media nutrition education program on caregiver infant and young child feeding knowledge, attitudes and practices using a community-based cluster randomized design. Formative research will first be undertaken to determine the beliefs, attitudes, and constraints that prevent caregivers from adequately feeding their infants and young children with members of the community (caregivers with children under-five, men and elderly women).The information gathered will then be used to design specific messages that directly address the IYC feeding challenges of the community. Clusters will be randomized into active (radio messages with in-person engagement and follow-up) and passive (only radio messages) arms of the intervention. Farm Radio International (implementers of the mass media programming) will ensure the regular broadcast of twice weekly messages for a period of about 12-18 months.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
689

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
2 countries

4 active sites

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

First Submitted

Initial submission to the registry

June 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

June 8, 2016

Last Update Submit

March 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in infant feeding behaviour assessed by questionnaire

    Change in child feeding behaviours that are promoted on radio

    12-18 months

Secondary Outcomes (2)

  • Change in infant feeding knowledge of mother assessed by questionnaire

    12-18 months

  • Change in infant feeding attitudes of mother assessed by questionnaire

    12-18 months

Study Arms (2)

Active mass media approach

EXPERIMENTAL

Communities will be exposed to twice weekly radio programming for up to 18 months plus interactive voice response systems (IVRS) and monthly open community meetings.

Behavioral: Active mass media approach

Passive mass media approach

EXPERIMENTAL

Communities will be exposed to twice weekly radio programming for up to 18 months

Behavioral: Passive mass media approach

Interventions

Communities will be exposed to twice weekly radio programming for up to 18 months. Interactive voice response systems (IVRS) will be promoted where listeners can chose to receive pre-recorded audio/voice messages or text messages on mobile phones. Messages will be consistent with the weekly radio program. The topic of the radio program will be discussed in monthly open community meetings. Each individual may choose to participate or not to listen to the radio program, receive the IVRS system, and attend monthly meetings.

Active mass media approach

These communities will be exposed to twice weekly radio programming for up to 18 months only.

Passive mass media approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lives in cluster randomly assigned to either active or passive arm
  • has child \< 5 y of age
  • is the primary caregiver of the child

You may not qualify if:

  • has physical condition/illness that prevents from taking care of child
  • has physical condition/illness that prevents from responding to surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

World Vision

Toronto, Ontario, Canada

Location

McGill University

Montreal, Quebec, H3A 2T5, Canada

Location

Farm Radio International

Accra, Ghana

Location

University of Ghana

Legon, Ghana

Location

MeSH Terms

Conditions

Health EducationMalnutrition

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Grace S Marquis, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study design and communities' status as active or passive are not discussed with the field staff.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 15, 2016

Study Start

April 1, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations