Evaluation of an integrated mother and child grant project in Malawi

ISRCTN	ISRCTN53055824
DOI	https://doi.org/10.1186/ISRCTN53055824
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	IFPRI_PON_17022022
Sponsor	Power of Nutrition
Funders	Power of Nutrition, Conrad N. Hilton Foundation, Foreign, Commonwealth and Development Office

Submission date: 04/03/2022
Registration date: 07/03/2022
Last edited: 15/01/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Children in Malawi face high rates of malnutrition and are at risk of not reaching their developmental potential. In Malawi, community-based childcare centres (CBCCs) can be cost-effective platforms for scaling-up nutrition social behaviour change (SBC) interventions. However, evidence also suggests potential synergies from coupling nutrition SBC to cash transfers (CT) in Malawi, given that rural households face high levels of poverty and recurring extreme lean season food-security shocks. The aim of this study is to evaulate the cost-effectiveness of using CBCCs and parenting care-groups as platforms to improve maternal diets and child nutrition and development by providing nutrition-sensitive behaviour change and cash transfer intervention packages in communities already receiving a standard of care Government early childhood development (ECD) SBC program.

Who can participate?
1. Women aged 15 to 49 years who are pregnant living in the catchment area of the CBCC whose pregnancy is confirmed by a urine pregnancy test
2. Mothers (aged 15 to 49 years) of children aged under 24 months and their youngest children living in the catchment area of the CBCC

What does the study involve?
Communities will be randomly allocated to one of four groups to receive:
1. Standard of Care (SoC): the standard Government ECD SBC program
2. The SoC intervention with additional nutrition, ECD and agriculture SBC activities to improve nutritious food production, diets and care practices for young children
3. SoC plus SBC plus a maternal and child cash transfer of about US$20 per month
4. SoC plus SBC plus a maternal and child cash transfer of about US$35 per month
The intervention lasts 3 years.

What are the possible benefits and risks of participating?
The intervention could improve the diets and feeding practices of participants through improved knowledge of caregivers resulting from the nutrition SBC. The SBC intervention could also influence farming practices, increasing production and changing crop production mix. This could in time (and after the main harvest) improve the household availability of nutritious foods and combined with the parent nutrition training result in improved diets at home. The additional focus on diets and nutrition could reinforce the focus on care and stimulation of young children, improving synergies across the two sectors, whilst increasing the salience of the core training and its relevance within households and the community. The cash transfer intervention is expected to directly increase women’s income and empowerment, while also support the changing of preferences and attitudes related to nutritious foods; increasing physical, emotional and financial resources to channel towards maternal and child health, child nutrition and development, including to improve the meals at home and in the CBCCs. There are no known risks related to the intervention involved.

Where is the study run from?
1. International Food Policy Research Institute (USA)
2. Save the Children (Malawi)

When is the study starting and how long is it expected to run for?
February 2022 to December 2025

Who is funding the study?
1. The Power of Nutrition (UK)
2. Conrad N Hilton Foundation (USA)
3. Foreign, Commonwealth and Development Office (UK)

Who is the main contact?
Dr Aulo Gelli
A.Gelli@cgiar.org

Contact information

Dr Aulo Gelli
Principal investigator

IFPRI, 1201 Eye Street NW
Washington, DC
20005-3915
United States of America

ORCID ID	0000-0003-4977-2549
Phone	+1 (0)202 8125611
Email	a.gelli@cgiar.org

Study information

Primary study design	Interventional
Study design	Randomized control trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Impact evaluation of a maternal and child cash transfer intervention, integrated with nutrition, early-childhood development and agriculture in Malawi
Study acronym	MAZIKO
Study objectives	The MAZIKO trial is aimed at aimed at evaluating the cost-effectiveness of using the integrated community-based childcare centre (CBCC) and care-group platform to improve maternal and child nutrition and development by providing variations of nutrition-sensitive intervention packages in communities receiving standard Government support.
Ethics approval(s)	Approved 27/02/2022, International Food Policy Research Institute (IFPRI) IRB (1201 Eye Street NW, Washington, DC, USA; +1 (0)202 862 5600; IFPRI-IRB@cgiar.org), ref: #00007490
Health condition(s) or problem(s) studied	Maternal and child nutrition and development
Intervention	The MAZIKO trial is aimed at evaluating the cost-effectiveness of using CBCCs and parenting care-groups as platforms to improve maternal diets, and child nutrition and development by providing nutrition-sensitive behaviour change and cash transfer intervention packages in communities already receiving a standard of care Government early childhood development (ECD) SBC program. This is a 3-year cluster randomised trial in two districts of Malawi, including 160 communities randomised using a public lottery to one of four treatment arms: 1. Standard of Care (SoC) arm: receiving the standard Government ECD social behaviour change (SBC) program 2. SBC arm: receiving the SoC intervention with additional nutrition, ECD and agriculture SBC activities to improve nutritious food production, diets and care practices for young children 3. Low CT arm: SoC plus SBC plus a maternal and child cash transfer ~US$20 per month 4. High CT arm: SoC plus SBC plus a maternal and child CT ~US$35 per month. Duration of intervention: 3 years
Intervention type	Mixed
Primary outcome measure(s)	1. The adequacy of nutrient intake in index women 15-49 years of age at baseline who are pregnant or mothers of index children 0-2 years at baseline, measured through 24 h recall at endline 2. Child development (motor, language and cognition) in index children (in utero to 2 years at baseline) measured using the Malawi Development Assessment Tool at endline
Key secondary outcome measure(s)	1. Diet quality measured using the Global Diet Quality Score in index women 15-49 years of age at baseline who are pregnant or mothers of index children as measured through 24 h recall at endline 2. The adequacy of nutrient intake in index children measured through 24 h recall at endline 3. Height, HAZ, stunting (HAZ<-2), weight, weight for height, wasting (WHZ <-2), mid-upper arm circumference (MUAC) and head circumference in index children, as measured through anthropometric assessments at endline 4. Effects along the program impact pathways (PIPs) linking program implementation of each randomized interventions to nutrient adequacy of intake in index women and children, and other outcomes by assessing: 4.1. Fidelity of intervention implementation for each of the randomized interventions, defined as conformance with implementation specifications as measured through self-reports at endline 4.2. Quality of CBCC and Care Group training and supervision as measured through self-reports at endline 4.3. CBCC and Care Group volunteer capacity and service provision as related to the All Children Surviving and Thriving framework as assessed by questionnaire and observations at endline 4.4. Attained maternal knowledge and practices as related to the All Children Surviving and Thriving framework as assessed by questionnaire and direct observations at endline 5. Women’s empowerment measured using the women’s empowerment in agriculture (pro-WEAI) indicator at endline 6. Maternal depression measured using the Self-Reporting Questionnaire (SRQ) at endline 7. Household expenditure levels, shares of expenditures, poverty and food-insecurity levels assessed by questionnaire at endline 8. Household food consumption elasticities for calories and micronutrients assessed by questionnaire at endline 9. Mother’s willingness to pay (WTP) for nutrient-dense complementary foods assessed by questionnaire at endline If funding permits: 10. Haemoglobin concentration and anaemia prevalence in women and children measured through capillary blood assessment at endline
Completion date	30/12/2025

Eligibility

Participant type(s)	Other
Age group	Mixed
Sex	All
Target sample size at registration	3200
Key inclusion criteria	1. All women aged between 15 to 49 years who are pregnant living in the catchment area of the CBCC whose pregnancy is confirmed by a urine pregnancy test 2. Mothers (aged 15 to 49 years) of children aged <24 months and their youngest children (index) living in the catchment area of the CBCC
Key exclusion criteria	1. Women residing in the study area who are pregnant during the enrolment period but do not consent to participate in the trial 2. Women residing in the study area who self-report being pregnant during the enrolment period but are unable to confirm their pregnancy. These women will be eligible for participation in the program 3. Children with major non-fatal disabilities will not be excluded from study procedures, but will be excluded from the final analysis sample if the disability is likely to directly affect growth and development
Date of first enrolment	01/04/2022
Date of final enrolment	01/07/2022

Locations

Countries of recruitment

Malawi
United States of America

Study participating centres

International Food Policy Research Institute

1201 Eye Street NW
Washington, DC
20000
United States of America

Save the Children, Malawi

Wilbes Court 3
Off Presidential Highway
Area 14
Lilongwe
PO Box 30374
Malawi

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		13/01/2024	15/01/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/01/2024: Publication reference added.
11/03/2022: Conrad N Hilton Foundation and Foreign, Commonwealth and Development Office added as funders.
04/03/2022: Trial's existence confirmed by the International Food Policy Research Institute.