- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975063
Alive & Thrive Nigeria Impact Evaluation
January 13, 2021 updated by: RTI International
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Adequate nutrition during the first 1,000 days is necessary for children to grow and develop to their full potential.
Alive & Thrive (A&T) contributes to better nutrition during the first 1,000 days by promoting improved infant and young child feeding (IYCF) practices.
A&T is expanding its efforts to Nigeria and will target Lagos and Kaduna States.
In Nigeria, 33% of infants are breastfed within 1 hour of delivery, 60% are given other fluids in the first 3 days of life, and only 17% of children 0-5.9 months are exclusively breastfed.
Approximately 60% of children 6 to 23 months achieve the minimum meal frequency for their age and 19% are fed four or more food groups per day.
To address these gaps in optimal IYCF practices, A&T will use an implementation framework for IYCF impact at scale that includes advocacy, interpersonal communication and community mobilization, mass communication, and strategic use of data.
The A&T intervention will be compared to mass media communication on IYCF, which will be provided throughout the two states.
LGAs in Lagos and Kaduna will be randomly allocated such that two-thirds receive the A&T intervention and one-third are assigned to the comparison group.
The primary objectives of the evaluation are to measure the impact of the A&T intervention on IYCF practices among mothers with children 0-23 months of age overall, in each state, and in a subset of urban LGAs.
Secondary evaluation objectives are to document: the type, quantity, and timing of the implementation of A&T program activities; coverage levels A&T achieves with different program activities; extent to which A&T increases knowledge and awareness of optimal IYCF practices among women with children 0 to 23 months and health providers; extent to which A&T improves the capacity of health providers to counsel mothers on IYCF; and extent to which A&T improves the capacity of stakeholders to implement community-based activities that support optimal IYCF practices.
Study Type
Interventional
Enrollment (Actual)
15169
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kaduna, Nigeria
- Kantar TNS RMS
-
-
Lagos
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Ikeja, Lagos, Nigeria
- Kantar TNS RMS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 49 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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,
- 18 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
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention.
|
|
Experimental: A&T IYCF intervention
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.
|
(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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exclusive breastfeeding on the day preceding the interview.
Time Frame: 2 years
|
The proportion of infants 0-5 months who were exclusively breastfed on the previous day.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exclusive breastfeeding from 0-5 months.
Time Frame: 2 years
|
The proportion of children who were exclusively breastfed from 0-5 months.
|
2 years
|
Breastfeeding within 1 hour of birth.
Time Frame: 2 years
|
The proportion of children 0-23 months who were breastfed within 1 hour of birth.
|
2 years
|
Minimum dietary diversity.
Time Frame: 2 years
|
The proportion of children 6-23 months who were fed the minimum number of food groups on the previous day based on the WHO infant and young child feeding guidelines.
|
2 years
|
Minimum meal frequency.
Time Frame: 2 years
|
Description: The proportion of children 6-23 months who were fed the minimum number of meals on the previous day based on the World Health Organization infant and young child feeding guidelines.
|
2 years
|
Mothers' accurate knowledge of optimal infant and young child feeding practices.
Time Frame: 2 years
|
Mothers' accurate knowledge of:
|
2 years
|
Health providers' knowledge of optimal infant and young child feeding practices.
Time Frame: 2 years
|
Providers' accurate knowledge of:
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Valerie Flax, RTI International
- Principal Investigator: Mariam Fagbemi, TNS RMS Nigeria, Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2017
Primary Completion (Actual)
December 2, 2020
Study Completion (Actual)
December 2, 2020
Study Registration Dates
First Submitted
October 19, 2016
First Submitted That Met QC Criteria
November 23, 2016
First Posted (Estimate)
November 29, 2016
Study Record Updates
Last Update Posted (Actual)
January 14, 2021
Last Update Submitted That Met QC Criteria
January 13, 2021
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 08100206
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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