Clinical trial NCT02775552: Impact Evaluation of a Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia
Official title: Impact Evaluation of Alive & Thrive's Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exclusive Breastfeeding
Complementary Feeding
Keywords: Child Nutrition
Breastfeeding
Complementary Feeding
Infant and Young Child Feeding
Social and Behavior Change Communication
Ethiopia
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: FHI 360
name: Save the Children
First posted: 2016-05-17
Enrollment: 3120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exclusive breastfeeding among children aged 0-5.9 months in the intervention areas only
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
measure: Minimum dietary diversity among children aged 6-23.9 months
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
measure: Minimum meal frequency of (semi) solid or soft foods among children aged 6-23.9 months
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Secondary outcomes:
measure: 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
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
measure: Continued breastfeeding at 1 year among children aged 12-15.9 months
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
measure: Timely introduction of (semi) solid or soft foods among children aged 6-8.9 months
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
measure: Minimum acceptable diet among children aged 6-23.9 months
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
measure: Consumption of iron-rich foods among children aged 6-23.9 months
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
measure: Mother's accurate knowledge of adequate child feeding practices
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
measure: Mother's beliefs, self-efficacy, and perceptions of social norms about child feeding during fasting
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
measure: Nutritional status of children 6-23 months of age
timeFrame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: International Food Policy Research Institute
Study officials:
affiliation: International Food Policy Research Institute
name: Purnima Menon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Food Policy Research Institute
name: Sunny S. Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.