Extended Pilot Project Community Based Production of Complementary Food in Ethiopia

NCT02484495 | Completed DMC

• 1 other identifier: EPHI_FSNRD_CF_MNP002
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

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. 1.What impact does the extended pilot (implementation of local complementary food production and MNP) have on:
2. 2.Growth in children 17-29 months of age
3. 3.Infant and Young Child Feeding practices in children (6-23m), and
4. 4.Anemia status in children 11-23 m?
5. 5.What are determining factors for the impact/no impact related to:
6. 6.Immediate outcomes: skills and capacity; knowledge, attitude and practices; and improved access
7. 7.Intermediate outcomes: utilization; provision, and ensuring enabling environment
8. 8.Program performance as measured by program monitoring data on output and activities?

Conditions

Growth Acceleration; Infant Morbidity

Keywords

Complementary feeding recommendation; Program evaluation; Process and impact evaluation

Outcome Measures

Primary Outcomes (1)

• % of children 17-29 months of age with HAZ < -2 SD

  The ultimate outcomes of the program are improved nutritional status of children which include improved Z-scores for height-for-age (HAZ) according to the child growth standard.

  Up to 18 months

Secondary Outcomes (6)

• Mean height

  Up to 18 months

• Z score:

  Up to 18 months

• Morbidity

  Up to 18 months

• Anemia status

  Up to 18 months

• % of children 6-23 months of age who were fed an minimum acceptable diet

  Up to 18 months

Study Arms (2)

Program evaluation in intervention areas

EXPERIMENTAL

A quasi-experimental matched-control cluster design will be used in which outcomes are compared in intervention and non-intervention areas. The program evaluation will have three points of data collection to assess effect of the program on the nutritional status of children 6-29 months. Sixty intervention clusters have been purposively selected whereas the data will be collected from randomly selected subjects. The following interventions will be provided: * Processed complementary food rations will be distributed to all children 6-23 months of age, from a grain bank based on bartering of raw materials. * Monthly 15 sachets of MNP will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification.

Other: Program evaluation (impact assessment)

Non intervention areas

NO INTERVENTION

A quasi-experimental matched-control cluster design will be used in which outcomes will be compared in intervention and non-intervention clusters. The program evaluation will have three points of data collection to assess effect of the program on the nutritional status of children 6-29 months. Matching sixty non-intervention clusters have been purposively selected out of the predetermined non- intervention districts whereas study subjects will be randomly selected from the identified clusters on a population based sampling method both groups. These non-intervention areas do not get processed complementary food rations and do not receive MNPs.

Interventions

Program evaluation (impact assessment) OTHER

The program activities include: processed complementary food rations which will be distributed to all children 6-23 months of age, in a grain bank based on bartering of raw materials; enhanced Infant and Young Child Nutrition (IYCN) counselling will be given to the mothers of children 6-23 month of age, using improved Behavior messages based Change Intervention (BCI) on formative research. Monthly 15 MNPs sachets will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification on every alternate day.

Program evaluation in intervention areas

Eligibility Criteria

• Age: 6 Months - 29 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethiopian Public Health Institute: lead
• Micronutrient Initiative: collaborator
• Wageningen University: collaborator

Study Sites (1)

Ethiopian Public Health Institute

Addis Ababa, 1242/5456, Ethiopia

Location

Related Publications (4)

• 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.

  PMID: 24261077 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• WHO. Indicators for assessing infant and young child feeding practices. Part I definitions. 2008

  BACKGROUND

Related Links

• Sponsor's website

MeSH Terms

Interventions

Program Evaluation

Intervention Hierarchy (Ancestors)

Evaluation Studies as Topic; Investigative Techniques; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Saskia JM Osendarp, PhD

  Micronutrient Initiative

  STUDY CHAIR

• Inge D Brouwer, PhD

  Wageningen University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 29, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2017
• Last Updated: January 31, 2018

Record last verified: 2017-02

Locations

ET (1)