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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05181293
Other study ID # STUDY00001047
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 23, 2022
Est. completion date May 2024

Study information

Verified date December 2022
Source University of Texas at Austin
Contact Jeanne H Freeland-Graves, PhD, RD
Phone 512-619-3102
Email jfg@mail.utexas.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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. Pregnancy elevates the nutrient needs of teenage girls due to competing requirements for fetal development, and growth and maturity in the adolescent mother. The resultant children have a higher likelihood of underweight (13-fold), stunting (8-fold) and wasting (3-fold), and are over 50% more likely to die within the first month of birth, as compared to children of older mothers. Previous studies have found positive associations between maternal education/knowledge and optimum infant and young child feeding (IYCF) practices. Childbirth results in a sharp increase in the responsibilities and work burden of teenage mothers, negatively impacting capacity and self-efficacy for adequate child feeding. Furthermore, attempts to improve IYCF practices often target older women. 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. A secondary goal is to evaluate the anthropometric and dietary and plasma levels of microminerals of children, 0 - 24 months of age. A mobile app will be developed and validated. It will feature an interactive role-play game on recommended IYCF practices that will help educate teenage mothers about feeding young children. A 6-month randomized controlled trial (RCT) will be conducted in 266 predominantly low-income mother-child dyads (0 - 24 months) from Nigeria. This RCT will compare the influence of the BabyThrive app vs controls who receive a delayed intervention. It will include knowledge and practices regarding exclusive breastfeeding, introduction to solid/semi-solid foods, meal frequency, dietary diversity and amount of food consumed of teenage mothers. Anthropometric measurements and plasma ferritin and zinc of children also will be evaluated.


Recruitment information / eligibility

Status Recruiting
Enrollment 266
Est. completion date May 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Months to 19 Years
Eligibility Inclusion Criteria: - Teenage mothers with children aged 0 - 24 months Exclusion Criteria: - Children with acute infections, metabolic or feeding issues - Mothers younger than 14 years of age - HIV-positive mothers

Study Design


Intervention

Behavioral:
Mobile Gaming App for Nutrition Intervention
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.

Locations

Country Name City State
Nigeria Center for Family Health Initiative Abuja Federal Capital Territory

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

Nigeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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