NCT02975063

Brief Summary

Investigators will use a cluster-randomized design to evaluate the overall impact of the Alive \& Thrive infant and young child feeding communication strategies in Lagos and Kaduna States, Nigeria. The impact in each state and in a subset of urban local government areas (LGAs) will also be tested.This is a mixed methods evaluation; the quantitative data will be complemented by qualitative data obtained from different groups targeted by or involved in the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15,169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

October 19, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 19, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed
Last Updated

January 14, 2021

Status Verified

August 1, 2020

Enrollment Period

3.9 years

First QC Date

October 19, 2016

Last Update Submit

January 13, 2021

Conditions

Complementary Feeding

Keywords

Exclusive breastfeeding

Outcome Measures

Primary Outcomes (1)

  • Exclusive breastfeeding on the day preceding the interview.

    The proportion of infants 0-5 months who were exclusively breastfed on the previous day.

    2 years

Secondary Outcomes (6)

  • Exclusive breastfeeding from 0-5 months.

    2 years

  • Breastfeeding within 1 hour of birth.

    2 years

  • Minimum dietary diversity.

    2 years

  • Minimum meal frequency.

    2 years

  • Mothers' accurate knowledge of optimal infant and young child feeding practices.

    2 years

  • +1 more secondary outcomes

Study Arms (2)

A&T IYCF intervention

EXPERIMENTAL

A\&T IYCF intervention is includes comprehensive IYCF counseling which includes intensive activity that aims to deliver one-on-one counseling at home or in a health facility.

Behavioral: A&T IYCF intervention

Control

NO INTERVENTION

No intervention.

Interventions

A&T IYCF interventionBEHAVIORAL

(1) Interpersonal communication through frontline workers/volunteers to increase mothers' knowledge and practice of optimal infant and young child feeding (IYCF) behaviors. Interpersonal communication will involve multiple contacts with mothers and an array of IYCF messages; (2) Community mobilization activities to raise awareness of the benefits of optimal IYCF practices among opinion leaders and family members, and increase their support to mother for IYCF; (3) Training of facility and community-based health workers on IYCF to improve their ability to support mothers and provide timely information on IYCF; and (4) Mass media communication on IYCF.

A&T IYCF intervention

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For mother's survey:
  • Women of reproductive age (15-49 years),
  • Must be married if 15-17 years,
  • Has a child 0-23 months
  • For provider's survey:
  • Male or female,
  • years or older
  • Works in a government or private health facility or works as a community pharmacist, private patent medicine vendor, or traditional birth attendant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kantar TNS RMS

Ikeja, Lagos, Nigeria

Location

Kantar TNS RMS

Kaduna, Nigeria

Location

Related Publications (1)

  • Flax VL, Fagbemi M, Schnefke CH, Kawu AA, Edwards S, Unangst J, Bose S. Impacts of a social and behavior change communication program implemented at scale on infant and young feeding practices in Nigeria: Results of a cluster-randomized evaluation. PLoS One. 2022 Dec 8;17(12):e0277137. doi: 10.1371/journal.pone.0277137. eCollection 2022.

    PMID: 36480569DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Valerie Flax

    RTI International

    PRINCIPAL INVESTIGATOR

  • Mariam Fagbemi

    TNS RMS Nigeria, Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2016

First Posted

November 29, 2016

Study Start

January 19, 2017

Primary Completion

December 2, 2020

Study Completion

December 2, 2020

Last Updated

January 14, 2021

Record last verified: 2020-08

Locations

NG(2)