Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04835662
Other study ID # 20575
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2019
Est. completion date September 25, 2020

Study information

Verified date February 2021
Source RTI International
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This was pre-post study designed to measure changes in complementary feeding practices and document the feasibility and acceptability of an intervention to engage fathers in supporting dietary diversity in Kaduna State, Nigeria. This study was conducted as part of the Alive & Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design and implementation of the study, with Datametrics Associates Ltd. serving as the data collection partner in Nigeria. The study was carried out in 6 wards (2 urban, 4 rural) of Igabi local government area in Kaduna State. We collected survey data cross-sectionally from 495 cohabiting mothers and fathers of children 6-23 months at baseline and endline. Participants were randomly sampled within 99 clusters selected proportional to population size. The purpose of the surveys was to obtain data on children's complementary feeding, changes in fathers' and mothers' knowledge and attitudes related to complementary feeding, and fathers' support for complementary feeding, and to measure participants' exposure to the intervention components. To measure feasibility and acceptability of the intervention, we conducted 24 in-depth interviews at the end of the intervention with community and religious leaders and Community Health Extension Workers who were involved in implementing the intervention. In addition, we conducted separate focus group discussions with mothers and fathers (8 groups each) at the end of the intervention to learn about changes in social norms related to fathers' engagement in complementary feeding and their experiences with participating in the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 2168
Est. completion date September 25, 2020
Est. primary completion date September 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 49 Years
Eligibility Inclusion Criteria: For the surveys, men 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. For the qualitative component, mothers, fathers, community and religious leaders, and community health extension workers who participated in the intervention were eligible. - Exclusion Criteria: Refusal to participate or provide consent. -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Complementary feeding promotion
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.

Locations

Country Name City State
Nigeria Alive and Thrive Kaduna

Sponsors (2)

Lead Sponsor Collaborator
RTI International FHI 360

Country where clinical trial is conducted

Nigeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Minimum feeding frequency The proportion of children 6-23 months who consumed minimum number of meals by age group and breastfeeding status (WHO indicator definition) 24 hours
Secondary Minimum acceptable diet Proportion of children 6-23 months with both minimum dietary diversity and minimum meal frequency (WHO indicator definition) 24 hours
Secondary Consumption of specific food group Proportion of children 6-23 months who consumed each of the 7 food groups that make up the dietary diversity indicator 24 hours
See also
  Status Clinical Trial Phase
Terminated NCT03589963 - Providing Postnatal Breastfeeding Support Through the Canada Prenatal Nutrition Program N/A
Completed NCT03675607 - Preparation of Complementary Feeding in Spain: a Cross-sectional Study
Completed NCT02775552 - Impact Evaluation of a Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia N/A
Completed NCT01084109 - First Bites: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial Phase 3
Completed NCT02975063 - Alive & Thrive Nigeria Impact Evaluation N/A
Completed NCT05771324 - The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development N/A
Completed NCT03891589 - Optimized Complementary Feeding With or Without Home Fortification Prevents Decrease of Micronutrient and Growth N/A
Recruiting NCT05805514 - Improving Growth and Cognitive Development of the Disadvantaged Young Children in Resource Poor Setting N/A
Not yet recruiting NCT06231602 - The Relationship Between Maternal Perinatal Depression and Feeding Behavior Among Primiparas
Not yet recruiting NCT03206424 - Patterns of Complementary Feeding in Infancy N/A
Recruiting NCT05517577 - An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes N/A
Completed NCT03400605 - Parkdale Infant Nutrition Security Targeted Evaluation Project: Infant Feeding
Completed NCT02740842 - A Follow-up Study on the Sustained Impact of Alive & Thrive Interventions on Infant and Young Child Feeding Practices N/A
Completed NCT01676623 - Impact Evaluation of a Social Franchise Model for Improving Infant and Young Child Feeding and Child Nutrition in Vietnam N/A
Completed NCT01678716 - Impact of Behavior Change Communications and Market-based Approach to Delivering Micronutrient Powders on Stunting, Infant Feeding Practices and Anemia in Bangladesh N/A