NCT04694898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2021

Completed
Last Updated

May 3, 2021

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 22, 2020

Last Update Submit

April 30, 2021

Conditions

Keywords

StuntingDiet diversityFood productionHousehold food securityWomen empowermentKnowledge, Attitudes and PracticesAnemiaMalaria

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin (g/dl)

    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)

    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 Outcomes (7)

  • Dietary diversity (%)

    Baseline (2016) and after 4 years at endline (2020)

  • Food insecurity access prevalence (%)

    Baseline (2016) and after 4 years at endline (2020)

  • Women's empowerment in agriculture (%)

    After 4 years of intervention (endline, 2020)

  • Maternal knowledge of child care practices related to health/diet/WASH (%)

    Baseline (2016) and after 4 years at endline (2020)

  • Maternal practices of child care related to health/diet/WASH (%)

    Baseline (2016) and after 4 years at endline (2020)

  • +2 more secondary outcomes

Other Outcomes (1)

  • Wasting (Z-score and %)

    Baseline in children 0-23 months of age and endline in children 4-6 years of age

Study Arms (2)

Control

OTHER

Households in the control arm receive standard/national nutrition specific interventions, i.e. growth monitoring, vaccination, vitamin A supplementation and deworming

Behavioral: Standard programme

SURE Intervention

EXPERIMENTAL

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

Behavioral: SURE intervention

Interventions

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.

Also known as: Control
Control

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.

Also known as: Intervention
SURE Intervention

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethiopia Public Health Institute

Addis Ababa, Ethiopia

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Growth DisordersMalnutritionAnemiaBehaviorMalaria

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Stefaan De Henauw, Md. PhD

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Souheila Abbeddou, MSc. PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

January 5, 2021

Study Start

December 28, 2020

Primary Completion

March 13, 2021

Study Completion

March 13, 2021

Last Updated

May 3, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

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

Locations