NCT04835662

Brief Summary

The purpose of this study was to evaluate an intervention to engage fathers in supporting the dietary diversity and other complementary feeding practices of their young children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

April 6, 2021

Last Update Submit

April 6, 2021

Conditions

Complementary Feeding

Keywords

Minimum dietary diversityMinimum meal frequency

Outcome Measures

Primary Outcomes (1)

  • Minimum dietary diversity

    The proportion of children 6-23 months who consumed at least 4 food groups on the previous day (World Health Organization indicator definition)

    24 hours

Secondary Outcomes (3)

  • Minimum feeding frequency

    24 hours

  • Minimum acceptable diet

    24 hours

  • Consumption of specific food group

    24 hours

Study Arms (1)

Complementary feeding promotion

OTHER

Intervention

Behavioral: Complementary feeding promotion

Interventions

Complementary feeding promotionBEHAVIORAL

The intervention engaged fathers through community meetings, religious services, and mobile phone text and voice messages. Mothers received home visits from community health extension workers (CHEWs), which fathers also could attend. Social behavior change communication materials included TV and radio messages, sermon guides, counseling cards, pamphlets, posters, and feeding bowls.

Complementary feeding promotion

Eligibility Criteria

Age15 Years - 49 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMen were eligible to participate in the surveys if they were 18 years of age or older, had a child aged 6 to 23 months, and were living in the same household as the child's mother. Women were eligible to participate if they were aged 18 to 49 years or aged 15 to 17 years and married, had a child aged 6 to 23 months, and were living in the same household as the child's father
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alive and Thrive

Kaduna, Nigeria

Location

Related Publications (2)

  • Allotey D, Flax VL, Ipadeola AF, Kwasu S, Adair LS, Valle CG, Bose S, Martin SL. Fathers' Complementary Feeding Support Strengthens the Association Between Mothers' Decision-Making Autonomy and Optimal Complementary Feeding in Nigeria. Curr Dev Nutr. 2022 Jun 2;6(7):nzac098. doi: 10.1093/cdn/nzac098. eCollection 2022 Jul.

    PMID: 35854939DERIVED

  • Flax VL, Ipadeola A, Schnefke CH, Kwasu S, Mikail AA, Bose S, Brower AO, Edwards S. Complementary Feeding Social and Behavior Change Communication for Fathers and Mothers Improves Children's Consumption of Fish and Eggs and Minimum Meal Frequency in Kaduna State, Nigeria. Curr Dev Nutr. 2022 Apr 8;6(5):nzac075. doi: 10.1093/cdn/nzac075. eCollection 2022 May.

    PMID: 35669047DERIVED

Study Officials

  • Valerie Flax

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 8, 2021

Study Start

May 31, 2019

Primary Completion

September 25, 2020

Study Completion

September 25, 2020

Last Updated

April 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

The data will be open

Time Frame
January 31, 2022

Locations

NG(1)