- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02775552
Impact Evaluation of a Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia (A&T-2 Ethiopia)
Impact Evaluation of Alive & Thrive's Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Addis Ababa, Ethiopia
- International Food Policy Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
---|---|
Experimental: A&T intervention areas
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Radio campaign - radio drama series, spots, and jingles
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Active Comparator: Comparison areas
(Receive standard government services)
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Radio campaign - radio drama series, spots, and jingles
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What is the study measuring?
Primary Outcome Measures
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
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The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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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
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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.
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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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
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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.
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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Secondary Outcome Measures
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
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The proportion of children aged less than 24 months who were breastfed within 1 hour of birth.
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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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
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The proportion of children aged 12-15.9
months who were breastfed on the day preceding the interview.
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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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
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The proportion of infants aged 6-8.9 months who received (semi) solid or soft foods on the day preceding the interview.
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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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
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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.
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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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
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The proportion of children aged 6-23.9 months who received an iron-rich or iron-fortified food on the day preceding the interview.
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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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
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Proportion of mothers who report correct knowledge about breastfeeding and complementary feeding practices based on questionnaire
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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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
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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
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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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
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Prevalence of stunting, underweight and wasting among children 6-23 months
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2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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Collaborators and Investigators
Investigators
- 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
General Publications
- Kim SS, Nguyen PH, Tran LM, Alayon S, Menon P, Frongillo EA. Different Combinations of Behavior Change Interventions and Frequencies of Interpersonal Contacts Are Associated with Infant and Young Child Feeding Practices in Bangladesh, Ethiopia, and Vietnam. Curr Dev Nutr. 2019 Dec 9;4(2):nzz140. doi: 10.1093/cdn/nzz140. eCollection 2020 Feb.
- Kim SS, Nguyen PH, Yohannes Y, Abebe Y, Tharaney M, Drummond E, Frongillo EA, Ruel MT, Menon P. Behavior Change Interventions Delivered through Interpersonal Communication, Agricultural Activities, Community Mobilization, and Mass Media Increase Complementary Feeding Practices and Reduce Child Stunting in Ethiopia. J Nutr. 2019 Aug 1;149(8):1470-1481. doi: 10.1093/jn/nxz087.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID 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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