Impact Evaluation of a Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia (A&T-2 Ethiopia)

February 23, 2018 updated by: International Food Policy Research Institute

Impact Evaluation of Alive & Thrive's Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia

Alive & Thrive is an initiative that aims to scale up nutrition to save lives, prevent illness, and ensure healthy growth and development through improved infant young child feeding (IYCF) practices. The purpose of this study is to evaluate whether the Alive & Thrive intervention package, consisting of interpersonal communication, community mobilization activities, and radio campaign, can increase complementary feeding practices (minimum dietary diversity and minimum meal frequency) while sustaining exclusive breastfeeding rate among children less than two years of age. The impact evaluation uses a cluster-randomized design where 20 geographic clusters (woredas/districts) were randomized to two study arms - 10 intervention areas and 10 comparison areas. Repeated cross-sectional baseline and endline surveys will be used to assess program impact.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In Amhara, the median duration of exclusive breastfeeding (4.6 months) is the highest among all the other regions in the country, but complementary feeding indicators lag behind (2% minimum dietary diversity and 34% minimum meal frequency). As a result, A&T's program emphasis will be placed on increasing mothers' knowledge and skills to improve complementary feeding practices without compromising exclusive breastfeeding. Given the short duration of implementation, the goal is to show that it is possible to achieve behavior change related to IYCF through a multi-sector approach. The purpose of this study is to evaluate whether the Alive & Thrive intervention package, consisting of interpersonal communication, community mobilization activities, and radio campaign, can increase select complementary feeding practices (minimum dietary diversity and minimum meal frequency increased by 10 percentage points) while sustaining exclusive breastfeeding rate among children less than two years of age.

A cluster randomized design with repeated cross-sectional surveys at baseline (2015) and endline (2017) is used to assess impact of the A&T interventions in three western zones of Amhara, Ethiopia. In the three zones, 20 woredas (districts) were randomly assigned as 10 intervention and 10 comparison/control areas. A&T intervention areas are expected to receive intensive IYCF social and behavior change communication activities as well as exposure to a region-wide radio campaign. In accordance with program objectives, sample sizes for the household survey were estimated to detect changes in the three main impact indicators - sustained exclusive breastfeeding, improved minimum dietary diversity, and improved minimum meal frequency. The estimated household sample sizes are 400 children 0-5.9 months old for exclusive breastfeeding in the A&T intervention areas only and 1350 children 6-23.9 months old per study arm for complementary feeding practices, for a total sample size of 3100 children 0-23.9 months of age. Infant feeding practices will be assessed using before- and after- intervention-comparison area group differences between the baseline survey (March-April 2015) and endline survey (March-April 2017). In addition, surveys of frontline workers will help document their awareness and knowledge about IYCF, training, supervision, and delivery of interventions to beneficiary households.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Ethiopia
      • Addis Ababa, Ethiopia
        • International Food Policy Research Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gives informed consent
  • Being aged from 15 to 49 years (women of reproductive age)
  • Has at least one infant less than 24 months old who is currently alive and lives with her

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A&T intervention areas
Behavioral: A&T community-based interventions

  1. Interpersonal communication delivered by health workers and community volunteers at the health post and during home visits to:

    - Increase mothers' knowledge about adequate child feeding practices

  2. Interpersonal communication delivered by agricultural extension workers to:

    - Increase fathers' knowledge about nutrition-sensitive agriculture and child feeding

  3. Community mobilization activities to:

    • Raise awareness of child feeding practices among community members, and increase support to mothers (enhanced community conversations)
    • Increase mothers' knowledge about preparation of complementary foods (cooking demonstrations)
    • Raise awareness of adequate child feeding during fasting among family and community members (church sermons)

  4. Enhanced training of government health and agricultural extension workers in infant and young child feeding to:

    • Improve their ability to provide timely and appropriate information and support to mothers and families
Behavioral: Mass media
Radio campaign - radio drama series, spots, and jingles
Active Comparator: Comparison areas
(Receive standard government services)
Behavioral: Mass media
Radio campaign - radio drama series, spots, and jingles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exclusive breastfeeding among children aged 0-5.9 months in the intervention areas only
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Minimum dietary diversity among children aged 6-23.9 months
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of children aged 6-23.9 months months who received foods from 4 or more food groups on the day preceding the interview.
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Minimum meal frequency of (semi) solid or soft foods among children aged 6-23.9 months
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of children aged 6-23.9 months who received (semi) solid or soft foods the minimum number of times or more on the day preceding the interview.
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early initiation of breastfeeding among children aged 0-5.9 months in the intervention areas only and among children aged 6-23.9 months in intervention and comparison areas
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of children aged less than 24 months who were breastfed within 1 hour of birth.
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Continued breastfeeding at 1 year among children aged 12-15.9 months
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of children aged 12-15.9 months who were breastfed on the day preceding the interview.
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Timely introduction of (semi) solid or soft foods among children aged 6-8.9 months
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of infants aged 6-8.9 months who received (semi) solid or soft foods on the day preceding the interview.
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Minimum acceptable diet among children aged 6-23.9 months
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of children aged 6-23.9 months who received a minimum acceptable diet (minimum dietary diversity and minimum meal frequency) on the day preceding the interview.
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Consumption of iron-rich foods among children aged 6-23.9 months
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of children aged 6-23.9 months who received an iron-rich or iron-fortified food on the day preceding the interview.
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Mother's accurate knowledge of adequate child feeding practices
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Proportion of mothers who report correct knowledge about breastfeeding and complementary feeding practices based on questionnaire
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Mother's beliefs, self-efficacy, and perceptions of social norms about child feeding during fasting
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Proportion of mothers who report positive beliefs, self-efficacy, and perceptions of social norms about feeding animal source foods to children and feeding as often as usual during fasting based on questionnaire
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Nutritional status of children 6-23 months of age
Time Frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Prevalence of stunting, underweight and wasting among children 6-23 months
2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Food Policy Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FHI 360
Save the Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Purnima Menon, PhD, International Food Policy Research Institute
  • Principal Investigator: Sunny S. Kim, PhD, International Food Policy Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 601011

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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