Sustainable Undernutrition Reduction in Ethiopia (SURE)

April 30, 2021 updated by: University Ghent

Integrating Health and Agriculture Services for Improved Household Food Security and Nutritional Status of Mothers and Children 4-6 Years of Age

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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

1292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Addis Ababa, Ethiopia
        • Ethiopia Public Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Households in the control arm receive standard/national nutrition specific interventions, i.e. growth monitoring, vaccination, vitamin A supplementation and deworming
The control arm will receive national standard programme for women and children under the age of 2 years. This includes 1) national nutrition and health care including iron & folic acid (IFA) supplementation in pregnancy; 2) early initiation and exclusive breastfeeding until 6 months of age; 3) timely introduction of liquid and semi-solid complementary foods; and 4) diversified complementary foods.
Other Names:
  • Control
Experimental: SURE Intervention

Households in the intervention group with children younger than 2 years benefit from:

  1. Interpersonal contacts to provide counselling on infant and young child feeding practices (IYCF) and nutrition-sensitive agriculture advice to mothers and fathers of children under 24 months, inclusive of pregnant women and fathers-to-be, jointly delivered by the local health and agriculture extension workers during routine household visits
  2. Men's and women's group dialogues targeting all men and women in a given community network, facilitated also by the local health and agriculture extension workers
  3. Media campaign to reinforce IYCF and dietary diversity messages
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 ("WASH") practices.
Other Names:
  • Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin (g/dl)
Time Frame: Changes in hemoglobin (g/dl) and in prevalence of anemia (<11g/dl) will be measured over the course of the four year program period.
Hemoglobin concentrations (g/dL)
Changes in hemoglobin (g/dl) and in prevalence of anemia (<11g/dl) will be measured over the course of the four year program period.
Linear growth (Z-score and prevalence)
Time Frame: 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.
Child height (cm) and its Z-score
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary diversity (%)
Time Frame: Baseline (2016) and after 4 years at endline (2020)
Measured with a questionnaire using a qualitative food frequency questionnaire. Unit: Number of food group consumed and percentage of children having consumed 4 groups (upon 7) the previous three days.
Baseline (2016) and after 4 years at endline (2020)
Food insecurity access prevalence (%)
Time Frame: Baseline (2016) and after 4 years at endline (2020)
Measured with a questionnaire to calculate the Household Food Insecurity Access score.
Baseline (2016) and after 4 years at endline (2020)
Women's empowerment in agriculture (%)
Time Frame: After 4 years of intervention (endline, 2020)
Measured by questionnaire, It measures the roles and extent of women's engagement in the agriculture sector in five domains: (1) decisions about agricultural production, (2) access to and decision making power over productive resources, (3) control over use of income, (4) leadership in the community, and (5) time use. Percentage of women over a calculated score.
After 4 years of intervention (endline, 2020)
Maternal knowledge of child care practices related to health/diet/WASH (%)
Time Frame: Baseline (2016) and after 4 years at endline (2020)
Using questionnaire on knowledge. Percentage of women giving adequate answer.
Baseline (2016) and after 4 years at endline (2020)
Maternal practices of child care related to health/diet/WASH (%)
Time Frame: Baseline (2016) and after 4 years at endline (2020)
Using questionnaire on practices. Percentage of women giving adequate answer.
Baseline (2016) and after 4 years at endline (2020)
Child weight (Z-score and %)
Time Frame: 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.
Child weight (kg) and its Z-score
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.
Agricultural production diversity
Time Frame: Baseline (2016) and after 4 years at endline (2020)
The production of different food groups by the household members that correspond to those groups used in the dietary diversity index.
Baseline (2016) and after 4 years at endline (2020)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wasting (Z-score and %)
Time Frame: Baseline in children 0-23 months of age and endline in children 4-6 years of age
Child weight for height Z-score
Baseline in children 0-23 months of age and endline in children 4-6 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2020

Primary Completion (Actual)

March 13, 2021

Study Completion (Actual)

March 13, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All the data collected in the evaluation survey will be used in the analyses and shared as necessary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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