Clinical trial NCT02985359: Impact Evaluation of the WFP-Implemented Nutrition Program in Malawi
Official title: Impact Evaluation of the WFP-Implemented Nutrition Program in Malawi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undernutrition
Keywords: Program impact evaluation
Malawi
Lipid-based nutrient supplements
Social behavior change communication
Childhood stunting
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: United Nations World Food Programme (WFP)
name: Kamuzu University of Health Sciences
name: Children's Investment Fund Foundation
First posted: 2016-12-07
Enrollment: 556
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In both program and comparison sites the investigators will conduct baseline, midline (1 y), and endline (3 y) panel surveys among children 6-23 months of age and pregnant and lactating women in rural Malawi

Brief summary: The goal of this evaluation is to assess the impact of a 3.5 year, World Food Program (WFP) supplemental child feeding and nutrition services program in reducing stunting and improving linear growth in children from 6 through 24 months of age in a rural district of Malawi.

Detailed description: The prevalence of child stunting is high (\~47%) in Malawi. In response, the Government of Malawi, with technical support from WFP, launched a 3.5 year of comprehensive nutrition program that provides a small quantity of Lipid-based Nutrient Supplement (LNS) and a comprehensive infant and young child feeding (IYCF) and water and sanitation, and hygiene (WASH) social and behavior change communications (SBCC) package.

The aim of this study is to evaluate the impact of the comprehensive nutrition program in reducing stunting and improving linear growth in children from 6 through 24 months of age and improving infant and young child feeding knowledge and practices in rural Malawi. The study design is quasi-experimental with one program district and one comparison district. The program impact will be evaluated using three rounds of cross-sectional panel data at baseline (January-March, 2014), midline (January-March, 2015), and endline (January-March, 2017). Required sample size for cross-sectional panel is (n = 2400; 1200 per district at each time point) and for pregnant and lactating Women (n = 1200; 600 per district at each time point).

The study also includes the following components:

* Longitudinal study: Two longitudinal cohorts of children (derived from children aged 6-7 months assessed at baseline and mid-line) are followed every 6 months through 24 months of age. Sample size will be \~132; 66 per district in each cohort. As children in the main study, this group will be assessed for their anthropometry.
* Qualitative study: this qualitative study aims to better understand facilitators and barriers to program participation, and factors that influence behavior change among target households. In-depth interviews (IDI) with mothers (n=34) and household members (n=15), and focus group discussions (FGD) with community leaders (n=1 of 11 village chiefs) and program staff (n=1 with 12 community leaders of actions on nutrition (CLAN) and n=2 with a total of 21 care group volunteers \[CGV\]) will elucidate their perceptions of the program, the Nutributter (NB), and the SBCC messages.
* Process evaluation: The process evaluation will focus on describing and testing the program's implementation theory by evaluating and documenting program inputs, implementation processes and delivery, and outputs. The process evaluation will begin with a broad collection and review of available program documents and data, which are used for the development of the implementation and program theories. To the extent possible, this study will use existing coverage and utilization data from the program's monitoring systems, and will collect additional data needed to fully diagram and understand program implementation activities, procedures, and fidelity to program design. As a final step, the results of the process evaluation will be used to illustrate the program implementation activities that may be expected to contribute to program impacts.
* Cost effectiveness study: In addition to calculating the cost per child covered by the nutrition program in Ntchisi, Malawi, the investigators will use an incremental cost-effectiveness ratio (ICER) approach to report on cost per case of stunting averted and cost per 0.1 unit change in mean length-for-age z-score (LAZ).

Eligibility criteria: Inclusion Criteria:

* Children who live in villages sampled for the cross-sectional survey
* Children between 6.0 and 23.9 months of age
* Pregnant and lactating women who live in villages sampled for the cross-sectional survey
* Pregnant or lactating women with a child between the age of 0 to 5.9 months

Exclusion Criteria:

• None

Primary outcomes:
measure: Change in the prevalence of stunting (%)
timeFrame: Will assess at baseline, midline (1 year), and end line (3 years)
measure: Change in the prevalence of wasting (%)
timeFrame: Will assess at baseline, midline (1 year), and end line (3 years)
measure: Change in the prevalence of underweight (%)
timeFrame: Will assess at baseline, midline (1 year), and end line (3 years)
Secondary outcomes:
measure: Change in the prevalence of Iron Deficiency Anemia (IDA) (%)
timeFrame: Will assess at baseline and end line (3 years) among a subsample
measure: Change in the proportion of caregiver knowledge and attitude about infant and young child feeding (IYCF) (%)
timeFrame: Will assess at baseline, midline (1 year), and end line (3 years)
measure: Change in the proportion of caregiver knowledge, attitude and practice about infant and young child feeding (IYCF) (%)
timeFrame: Will assess at baseline, midline (1 year), and end line (3 years)
measure: Change in caregiver practice about handwashing
timeFrame: Will assess at baseline, midline (1 year), and end line (3 years)
Other outcomes:
Locations:
city: Zomba
country: Malawi
facility: Wadonda Consult Ltd
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Kristen Hurley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurley KM, Phuka J, Kang Y, Ruel-Bergeron J, Buckland AJ, Mitra M, Wu L, Klemm RDW, West KP, Christian P. A longitudinal impact evaluation of a comprehensive nutrition program for reducing stunting among children aged 6-23 months in rural Malawi. Am J Clin Nutr. 2021 Jul 1;114(1):248-256. doi: 10.1093/ajcn/nqab010.
citation: Kang Y, Hurley KM, Ruel-Bergeron J, Monclus AB, Oemcke R, Wu LSF, Mitra M, Phuka J, Klemm R, West KP Jr, Christian P. Household food insecurity is associated with low dietary diversity among pregnant and lactating women in rural Malawi. Public Health Nutr. 2019 Mar;22(4):697-705. doi: 10.1017/S1368980018002719. Epub 2018 Oct 31.