NCT05181293

Brief Summary

Undernutrition among children born to teenage mothers deserves urgent attention in Nigeria, where 27.2% of girls (15-19 years) living in rural areas have begun childbearing. The overall goal of this study is to develop, validate and evaluate the effects of a mobile gaming app on the infant and young child feeding practices of teenage mothers, and the nutritional status of children (0 - 2 years).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

December 17, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

December 17, 2021

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Infant and Young Child Feeding (IYCF) knowledge and practice scores of teenage mothers

    Mean change in scores from baseline, after 6 months of intervention. Measured at baseline and at 6 months after the intervention, using the Teen Moms IYCF Questionnaire (to be validated at the beginning of this study)

    Baseline, Month 6 of intervention

Study Arms (2)

Experimental

EXPERIMENTAL

A mobile gaming app (BabyThrive) will be disseminated to teenage mothers to help them learn about exclusive breastfeeding, introduction to solid/semi-solid foods, meal frequency and dietary diversity. BabyThrive will also demonstrate how to prepare 30 nutritious recipes for complementary feeding; create a calendar and set reminders to prompt mothers to access child health services; and plot growth patterns of the baby to facilitate growth monitoring.

Behavioral: Mobile Gaming App for Nutrition Intervention

No Intervention

NO INTERVENTION

In addition to routine health services, teenage mothers will receive the BabyThrive app after the intervention is completed. Participants will learn about exclusive breastfeeding, introduction to solid/semi-solid foods, meal frequency and dietary diversity. BabyThrive also will demonstrate how to prepare 30 nutritious recipes for complementary feeding; create a calendar and set reminders to prompt mothers to access child health services; and plot growth patterns of baby to facilitate growth monitoring.

Interventions

A mobile gaming app (BabyThrive) will be disseminated to teenage mothers to help them learn about exclusive breastfeeding, introduction to solid/semi-solid foods, meal frequency and dietary diversity. BabyThrive will also demonstrate how to prepare 30 nutritious recipes for complementary feeding; create a calendar and set reminders to prompt mothers to access child health services; and plot growth patterns of the baby to facilitate growth monitoring.

Experimental

Eligibility Criteria

Age0 Months - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Teenage mothers with children aged 0 - 24 months

You may not qualify if:

  • Children with acute infections, metabolic or feeding issues
  • Mothers younger than 14 years of age
  • HIV-positive mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Family Health Initiative

Abuja, Federal Capital Territory, Nigeria

Location

MeSH Terms

Conditions

Child Nutrition DisordersBehavior

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Jeanne H Freeland-Graves, PhD, RD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Bess Heflin Centennial Professor

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 6, 2022

Study Start

March 23, 2022

Primary Completion

August 15, 2024

Study Completion

August 15, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations