Clinical trial NCT04694898: Sustainable Undernutrition Reduction in Ethiopia
Official title: Integrating Health and Agriculture Services for Improved Household Food Security and Nutritional Status of Mothers and Children 4-6 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stunting
Dietary Deficiency
Anemia
Keywords: Stunting
Diet diversity
Food production
Household food security
Women empowerment
Knowledge, Attitudes and Practices
Anemia
Malaria
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Ethiopian Public Health Institute
First posted: 2021-01-05
Enrollment: 1292
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is part of the evaluation of the Government project "SURE". SURE intervention districts were pre-selected in four regions out of the nine regions in Ethiopia. The regions were selected because they are agrarian and have high food insecurity and stunting prevalence (Oromia, Amhara, SNNPR and Tigray). A total of 36 districts were selected and assigned to the SURE intervention.

Comparison control districts were selected in equal number in the same four agrarian regional strata. Districts were roughly matched based on stunting prevalence tertiles (low, medium or high) and food insecurity scores. Eligible households are households with at least one child under the age of 2 years. The intervention started in 2016 and included 4299 households, 2146 of which were included in the intervention group and 2153 in the control group. After baseline data collection, all households in the intervention group received counselling at household and community levels.
Primary purpose: PREVENTION

Brief summary: The causes of malnutrition are complex and addressing the problem requires integrated action among various sectors. Globally, much attention has been given to nutrition-specific interventions to address the immediate causes of undernutrition. But undernutrition prevalence is decreasing at a very slow rate. Nutrition-specific interventions address the immediate determinants of child undernutrition, such as inadequate food and nutrient intake, but do not consider the underlying causes such as food insecurity, poverty, and limited access to clean water, hygienic environments, and health services.

Ethiopia still has a high prevalence of undernutrition. The current situation of food insecurity and malnutrition in Ethiopia has pressurized the government in pursuing a number of nutritional-sensitive interventions to increase diversified food production and consumption like the Sustainable Undernutrition Reduction Program (SURE).

This study aims to investigate whether joint nutrition specific and sensitive interventions can lead to improved household food security, dietary diversification and improved nutritional status in Ethiopian mothers and their young children.

The study will be a community based longitudinal design and will use multistage cluster sampling at the Kebele and household levels in Amhara, Oromia, and Southern Nations, Nationalities, and Peoples' Region (SNNPR) regions.

Households will be randomly selected from the intervention and the non-intervention arms at Kebele level, with 15 households per Kebele. The same children whose baseline are available who were 0-23 months of age at the time of the baseline assessment in 2016 will be recruited as well as their mothers. This represents approximately third of the total sample size at baseline.

Detailed description: Globally 25% of children under age 5 years of age are stunted, i.e. the child's height is more than 2 standard deviations (SD) below the median length/height-for-age as determined by the world health organization child growth standards. Sub-Saharan Africa remains the region with the highest prevalence of undernutrition. Stunting, a multifactorial condition, develops as a result of sustained inadequate nutrition and recurrent infections. Socioeconomic and environmental factors are considered to be important determinants of stunting. Stunting has long term detrimental effects on cognitive development, school achievement and income and hence potentially perpetuates the vicious circle of poverty and malnutrition. Interventions that target directly maternal and child health and nutrition such as maternal supplementation with iron and folic acid and promotion of exclusive and continued breastfeeding, have proven effective in enhancing child and maternal nutrition status and in reducing mortality in women and children. The evidence accumulated over the previous years has also shown that if nutrition-sensitive approaches (i.e. women's empowerment, agriculture, food systems and education) are integrated in nutritional-specific interventions, they can significantly accelerate progress in countries with the highest burden of maternal and child undernutrition and mortality.

Diversified diet provides a balance of nutrients that promote healthy growth and development. Agricultural interventions to improve production of micronutrient-rich foods, through increased productivity, home gardening and diversification efforts have a significant potential to improve dietary diversity and micronutrient intake of children. However, in Ethiopia there is limited evidence on the contribution of nutrition-sensitive agricultural interventions on dietary diversity and nutritional status of children. Our study evaluates a larger governmental programme "sustainable undernutrition reduction in Ethiopia (SURE)", a multi-sector integrated health and agriculture programme that aims to strengthen the existing nutrition specific interventions by addressing two key determinants of undernutrition: inadequate complementary feeding and household dietary diversity.

The SURE package includes: 1) promoting diversified agriculture; 2) promoting infant and young child feeding practices; 3) women empowerment in decision making related to agriculture, food and health; and 4) enhanced food security and Water, Sanitation and Hygiene (so-called "WASH") practices.

The programme started in 2016 and is implemented by the Ministries of Health and Agriculture in Ethiopia through a funding by the Children's Investment Fund Foundation (CIFF). The Ethiopian Public Health Institute (EPHI) has been contracted by the Ethiopian Ministry of health to deliver the programme and to carry out its evaluation at the level of impact, process and cost-effectiveness.

Aims of the Study The study aims to investigate whether access to diversified food through improved nutrition education and enhanced diversity in local and household food production leads to improved household food security, which in turn results in diversified dietary consumption and improved nutritional status of children 4 -6 years of age.

In a control longitudinal study design, our primary objective is to assess the extent of diversified food production and consumption as a result of SURE intervention and to evaluate their effects on nutritional status of children in the target/intervention communities compared to the agricultural practices, food insecurity and nutritional status of children in comparable communities in the control group.

Our second objective is to identify factors that mediate the association between diversified food production and diversified food consumption and design a model for a modified intervention to strengthen the association between diversified food production and consumption at a household level.

Our third objective is to identify key barriers and opportunities of adopting infant and young child feeding practices (IYCF) and nutrition sensitive agriculture interventions.

Methodology The study is part of the evaluation of the government project "SURE". The evaluation will have a mixed-method study design (quantitative and qualitative). A longitudinal survey will be carried out in a representative sample of households four years post-intervention, at the end 2020. The survey will use multistage cluster sampling at the Kebele and household levels.

Quantitative data

Baseline data collection: The survey at baseline collects data on: 1) child (6-23 months) nutritional status (height, weight, and hemoglobin concentration); 2) Infant and YCF practices including breastfeeding, minimum meal frequency, minimum dietary diversity and minimum acceptable diet; 3) maternal knowledge, attitude and practice regarding IYCF; 4) women empowerment; 5) household food insecurity and dietary diversity; 6) water, sanitation and hygiene (WASH); and 7) health services and morbidity symptoms of the child during the 15 day-preceding the interview day (received vitamin A supplement in the previous 6 months; diarrhea; cough; fever and; attending the growth monitoring program).

Key behaviors and agriculture outcomes at household level in the intervention and in the control groups will also be collected. These are: number of trainings organized in the community; crop production diversity; animal husbandry (eggs, chicken, milk, small and large livestock for meat).

In addition to outcome indicators, socioeconomic indicators such as age, ethnic group and education level will also be collected.

Follow-up data collection: follow-up surveys will be conducted after an exposure of four years in the intervention and the control groups. The same indicators collected at baseline will be collected during 2020 but in households with children who will now be 4-6 years of age (hypothetically these children would have been exposed to the intervention).

Qualitative data Qualitative methods will be used to examine the quality of implementation mechanisms of change, and contextual data to help interpret findings of the impact evaluation. Additionally, household expenditure will be estimated to determine the average cost of the intervention per case of stunting averted

Eligibility criteria: Inclusion Criteria:

* Children 4 years - 6 years and their mothers/fathers and caregivers
* Participated in the baseline survey (2016)
* Resided in the Control communities during the last four years (control arm), or in the SURE intervention communities (intervention arm).

Exclusion Criteria:

-

Primary outcomes:
measure: Hemoglobin (g/dl)
timeFrame: Changes in hemoglobin (g/dl) and in prevalence of anemia (<11g/dl) will be measured over the course of the four year program period.
measure: Linear growth (Z-score and prevalence)
timeFrame: Change in height-for-age Z-scores will be measured as well as the change in the prevalence of stunting (HAZ<-2) over the course of the four year program period.
Secondary outcomes:
measure: Dietary diversity (%)
timeFrame: Baseline (2016) and after 4 years at endline (2020)
measure: Food insecurity access prevalence (%)
timeFrame: Baseline (2016) and after 4 years at endline (2020)
measure: Women's empowerment in agriculture (%)
timeFrame: After 4 years of intervention (endline, 2020)
measure: Maternal knowledge of child care practices related to health/diet/WASH (%)
timeFrame: Baseline (2016) and after 4 years at endline (2020)
measure: Maternal practices of child care related to health/diet/WASH (%)
timeFrame: Baseline (2016) and after 4 years at endline (2020)
measure: Child weight (Z-score and %)
timeFrame: Measurements were made for children between the ages of 0 and 23 months of age at baseline and 4 years later, at endline, when the children are between the ages of 4 and 6 years.
measure: Agricultural production diversity
timeFrame: Baseline (2016) and after 4 years at endline (2020)
Other outcomes:
measure: Wasting (Z-score and %)
timeFrame: Baseline in children 0-23 months of age and endline in children 4-6 years of age
Locations:
city: Addis Ababa
country: Ethiopia
facility: Ethiopia Public Health Institute
Study officials:
affiliation: University Ghent
name: Stefaan De Henauw, Md. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Souheila Abbeddou, MSc. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruel MT, Alderman H; Maternal and Child Nutrition Study Group. Nutrition-sensitive interventions and programmes: how can they help to accelerate progress in improving maternal and child nutrition? Lancet. 2013 Aug 10;382(9891):536-51. doi: 10.1016/S0140-6736(13)60843-0. Epub 2013 Jun 6.
citation: Reinbott A, Schelling A, Kuchenbecker J, Jeremias T, Russell I, Kevanna O, Krawinkel MB, Jordan I. Nutrition education linked to agricultural interventions improved child dietary diversity in rural Cambodia. Br J Nutr. 2016 Oct;116(8):1457-1468. doi: 10.1017/S0007114516003433. Epub 2016 Oct 5.
citation: Bahru BA, Jebena MG, Birner R, Zeller M. Impact of Ethiopia's productive safety net program on household food security and child nutrition: A marginal structural modeling approach. SSM Popul Health. 2020 Aug 26;12:100660. doi: 10.1016/j.ssmph.2020.100660. eCollection 2020 Dec.