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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02775552
Other study ID # 601011
Secondary ID
Status Completed
Phase N/A
First received May 12, 2016
Last updated February 23, 2018
Start date March 2015
Est. completion date April 2017

Study information

Verified date February 2018
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3120
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
A&T community-based interventions
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 Interpersonal communication delivered by agricultural extension workers to: - Increase fathers' knowledge about nutrition-sensitive agriculture and child feeding 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) 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
Mass media
Radio campaign - radio drama series, spots, and jingles

Locations

Country Name City State
Ethiopia International Food Policy Research Institute Addis Ababa

Sponsors (3)

Lead Sponsor Collaborator
International Food Policy Research Institute FHI 360, Save the Children

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exclusive breastfeeding among children aged 0-5.9 months in the intervention areas only 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
Primary Minimum dietary diversity among children aged 6-23.9 months 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
Primary Minimum meal frequency of (semi) solid or soft foods among children aged 6-23.9 months 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 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 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
Secondary Continued breastfeeding at 1 year among children aged 12-15.9 months 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
Secondary Timely introduction of (semi) solid or soft foods among children aged 6-8.9 months 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
Secondary Minimum acceptable diet among children aged 6-23.9 months 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
Secondary Consumption of iron-rich foods among children aged 6-23.9 months 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
Secondary Mother's accurate knowledge of adequate child feeding practices 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
Secondary Mother's beliefs, self-efficacy, and perceptions of social norms about child feeding during fasting 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
Secondary Nutritional status of children 6-23 months of age 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
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