Clinical trial NCT02484495: Extended Pilot Project Community Based Production of Complementary Food in Ethiopia
Official title: Evaluate the Impact of Package of Interventions on Growth and Micronutrient Status of Infant and Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Acceleration
Infant Morbidity
Keywords: Complementary feeding recommendation
Program evaluation
Process and impact evaluation
Lead sponsor: Ethiopian Public Health Institute
Sponsor class: OTHER_GOV
Collaborators: name: Micronutrient Initiative
name: Wageningen University
First posted: 2015-06-29
Enrollment: 1800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the impact of a package of interventions including production and distribution of locally produced complementary foods (via so-called "Grain-banks") and Micronutrient Powders (MNPs) supplementation, and optimized food based Complementary Feeding Recommendation, on growth and micronutrient status of infants and young children. The impact of the intervention package will be evaluated in a quasi-experimental matched-control cluster design in infants and young children between 6 - 29 months of age. The impact, outcome, and output indicators of infants/children will be assessed in cross-sectional samples at baseline, after 9 and 18 months. A total of60 pair clusters are selected in which 15 households per cluster will be identified from the eligible population. A total of 1800 children from intervention and match-controlled clusters, will be sampled in the target age groups. Qualitative and quantitative data will be collected to gather information on Knowledge, Attitude and Practice (KAP), Infant and Young Child Feeding practices, anthropometry and anemia, following the impact pathway developed for the study.

Research questions to be answered in this program evaluation are:

1. What impact does the extended pilot (implementation of local complementary food production and MNP) have on:

   1. Growth in children 17-29 months of age
   2. Infant and Young Child Feeding practices in children (6-23m), and
   3. Anemia status in children 11-23 m?
2. What are determining factors for the impact/no impact related to:

   1. Immediate outcomes: skills and capacity; knowledge, attitude and practices; and improved access
   2. Intermediate outcomes: utilization; provision, and ensuring enabling environment
   3. Program performance as measured by program monitoring data on output and activities?

Detailed description: The aim of this study is to assess the impact/effectiveness of the improved interventions on infant growth and micronutrient status so as to measure what would have happened in the absence of interventions. The study will be conducted in the same four regions in Ethiopia where the program intervention is taking place namely, Amhara, Tigray, Oromiya, and South Nations Nationalities and Peoples Region (SNNPR) regions.

* Sample size calculations assume an expected difference of 0.2 Standard Deviation (SD) in HAZ, and 5% difference in feeding practices, 80% power, and α-error of 5%; and a cluster effect of approximately 2.
* A total of 1800 children will be sampled in both intervention and non-intervention (control) villages. A total of 120 clusters are chosen for both groups. Each intervention cluster will be matched with a control cluster selected to be similar in geographical and ecological conditions, access to a health-care centre, status of food security and the existence of Community Based Nutrition (CBN) programme. Within each pair of clusters, households will be randomly selected after the complete listing of eligible households. A total of 15 households will be identified in each 120 clusters.
* Demographics and socio-economic status indicators will be collected using Demographic Health Surveys (DHS) methods.
* Infant and Young Child feeding indicators will be assessed in all children 6-23 months at baseline, mid- and endline
* Knowledge attitude and practices concerning the intervention exposure indicators including perceptions and utilization of complementary food, MNP, and the use and perceptions on the grain banks will be assessed at baseline, mid- and endline in caregivers.

Data analysis include:

* For demographic and socio- economic characteristics of the study participants descriptive statistics will be used.
* To calculate the nutritional status of children 6-23 months, Epi-Info/Emergency Nutrition Action (ENA) for SMART software will be used.
* The median (min, max) of the weight or number of MNP consumed per day during the intervention period will be calculated as measure of compliance; however analyses will be done based on intention-to-treat.
* Qualitative data will be recorded in digital recorders which will be transcribed first to local language then to English. Then specific themes will be identified and matrices will be prepared and data will be analysed.
* The qualitative data will be analysed separately and triangulation will be made to compare the results.
* All analysis will be done on an intention-to-treat basis, taking into account the matched-controlled design. For continuous variables we will use linear mixed models that include cluster, household and child as random effects to account for clustered observations. Fixed effects to be included in the model are covariates such as child's sex, age, household socio-economic status and relevant baseline values. Normality will be examined by creating a Quantile-Quantile (QQ) plot and subsequent visual inspection. Equal variances will be assured with Levene's test.
* For categorical variables mixed-effects logistic regression models will be used with random effects for cluster and households.

Eligibility criteria: Inclusion Criteria:

* Children between 6-23 m of age who receive Complementary Food (CF) through grain bank or commercial central production
* Living in one of the selected clusters(for intervention and nonintervention clusters)
* Those who receive MNP (15 sachets/month/child)
* Receive enhanced IYCF counselling
* Receive food based Complementary Food Recommendation (CFR)
* Free of chronic conditions that may impact their health

Exclusion criteria:

* Children between 6-23 m of age who do not get CF either through grain bank program or central production
* Those who do not get MNP
* Those who do not receive food based CFR
* Children with a chronic disease and/or chronic use of medications

Primary outcomes:
measure: % of children 17-29 months of age with HAZ < -2 SD
timeFrame: Up to 18 months
Secondary outcomes:
measure: Mean height
timeFrame: Up to 18 months
measure: Z score:
timeFrame: Up to 18 months
measure: Morbidity
timeFrame: Up to 18 months
measure: Anemia status
timeFrame: Up to 18 months
measure: % of children 6-23 months of age who were fed an minimum acceptable diet
timeFrame: Up to 18 months
measure: Mean weight
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Ethiopian Public Health Institute
Study officials:
affiliation: Micronutrient Initiative
name: Saskia JM Osendarp, PhD
role: STUDY_CHAIR
affiliation: Wageningen University
name: Inge D Brouwer, PhD
role: STUDY_DIRECTOR
References:
citation: Menon P, Rawat R, Ruel M. Bringing rigor to evaluations of large-scale programs to improve infant and young child feeding and nutrition: the evaluation designs for the Alive & Thrive initiative. Food Nutr Bull. 2013 Sep;34(3 Suppl):S195-211. doi: 10.1177/15648265130343S206.
citation: Ton G. The Mixing of Methods: A Three-Step Process for Improving Rigour in Impact Evaluations, LEI, In: RESEARCH WUA, CENTER eds. THE NETHERLANDS.; 2012
citation: Kusters CSLea. Making evaluations Matter: A practical guide for evaluators. Center for Development Innovations. . In: Wageningen University and Research centre ed. Wageningen, The Netherlands; 2011
citation: WHO. Indicators for assessing infant and young child feeding practices. Part I definitions. 2008