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Stronger evidence towards future scale up: Randomised Cluster Trial in Ethiopia (MAMI RISE)

Collaborators: London School of Hygiene and Tropical Medicine (LSHTM), Jimma University (Ethiopia), GOAL Ethiopia, and the Emergency Nutrition Network (ENN)

Donors: Eleanor Crook Foundation (ECF)

Overview of research

This five year research programme (2019-2024) is testing an integrated care approach (MAMI Care Pathway) in outpatient clinics in Ethiopia, in a partnership between ENN, LSHTM, Jimma University and GOAL Ethiopia funded by ECF.

The programme involves formative research to inform a randomised control trial (RCT) in Jimma Zone and Deder Woreda, accompanied by a process evaluation and economic evaluation.

The ultimate goal of this research is to provide critical outcome and implementation evidence to inform national (Ethiopian) and international policy and service development with a view to future sustainable scale.

Phase 1

Formative research (2019 to mid-2022) involved:

Phase 2

The RCT was launched in October 2022 in Jimma Zone and Deder Woreda. It is two armed (intervention and control) trial involves 30 randomly allocated clusters (heath centres) in Jimma and 9 clusters in Deder Woreda. Our target population are small and/or nutritionally at-risk infants aged <6m, as defined by the presence of anthropometric and non-anthropometric criteria.

The intervention health centres use the MAMI Care Pathway Package (adapted during formative phase), which involves regular follow-up to 6 months and structured support at outpatient facility level embedded within existing IMNCI-based services. It includes tailored support for specific clinical and feeding problems, and counselling on six core topics: relaxation, crying/sleep, nurturing care, family and community support, family planning, and complementary feeding.

The control health centres follow the standard Ethiopia 2019 severe malnutrition guidelines, which focus on inpatient care for infants with WLZ <-3 and/or severe feeding problems. Follow-up for other at risk infants is based on clinical judgement.

We will assess and report the main outcomes when infants reach 6 months of age. We will also conduct longer-term follow-ups at 12-, 18-, and 24-months.

The primary outcome is infant growth, measured by mean WAZ at age 6 months.

The main secondary outcomes are:

A process (realist) evaluation is being conducted in tandem, led by ENN to investigate if and how it has worked, for whom, under what circumstances, and an economic evaluation led by Jimma University. A scoping review of national policy guidance in collaboration with the MOH is also underway.

Latest update

RCT enrolment was completed in August 2023 and intervention period completed December 2023. RCT results of 6 month follow up outcomes will be available mid 2024 and launched in meetings in Ethiopia. Results from the process (realist) evaluation will also be available mid-year, helping to contextualise the RCT findings and provide critical implementation evidence to inform national policy-makers.  Economic evaluation will be available end of 2024.

Future plans

RCT follow up at 12 months of age will be completed July 2024. Pending funding, we intend to follow up at 18 months and 24 months of age.

 

For more information, contact: Marko Kerac, LSHTM, marko.kerac@lshtm.ac.uk or Marie McGrath, ENN, marie@ennonline.net

Meet the team

The research partnership comprises a strong team of experienced researchers and practitioners at London School of Hygiene and Tropical Medicine (LSHTM) (overall lead & coordinator), Jimma University (academic lead, Ethiopia), GOAL (operational) and ENN (process evaluation and learning).

LSHTM
Marko Kerac, Principal investigator
Carlos Grijalva-Eternod, Co-investigator and Research Manager
Emma Beaumont, Statistician & Data Manager
Prof Elizabeth Allen, Professor of Medical Statistics

Jimma University
Melkamu Berhane, Principal investigator (Jimma and Deder)
Prof Tsinuel Girma, Senior Co-investigator
Prof Alemseged Abdissa, Senior Co-investigator
Mubarek Abera, Co-investigator
Shimelis Girma, Co-investigator
Kiddus Yitbarek, Co-investigator
Nega Jibat, Co-investigator (to 2021)

GOAL
Hatty Barthorp, Research Advisor
Anley Haile, Research Lead (to 2021)
Endashaw Haile, Research Lead (from 2021)
Abdulhakim Ali, Research focal point
Ritu Ranu, Co-investigator, MAMI Advisor (to 2021)

ENN
Marie McGrath, Co-investigator 

Additional
Prof Jonathan Wells (UCL), Co-investigator/technical advisor
Dr Hannah Blencowe (LSHTM), Co-investigator/technical advisor
National Technical Advisory Group 
National Data Safety and Monitoring Board (DSMB)

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Stronger evidence towards future scale up: Randomised Cluster Trial in Ethiopia (MAMI RISE). www.ennonline.net/ourwork/research/mamiriseethiopia

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