- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985359
Impact Evaluation of the WFP-Implemented Nutrition Program in Malawi
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Zomba, Malawi
- Wadonda Consult Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Comparison district
Existing routine community health services by government
|
|
|
Program district
In addition to existing routine community health services by the government, daily 20g Nutributter (Lipid-based Nutrient Supplement, LNS) will be provided to children 6 to 24 month of age and caregivers will participate in Social and Behavior Change Communications (SBCC) activities including the promotion of infant and young child feeding (IYCF) behaviors and water, sanitation and hygiene (WASH) behaviors will be conducted with caregivers.
|
Daily 20g Nutributter provided to children 6 to 24 month of age
Other Names:
Social Behavioral Change Communication (SBCC) activity focused on improving infant and young child feeding (IYCF) practices and water, sanitation, and hygiene (WASH) behaviors through community groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the prevalence of stunting (%)
Time Frame: Will assess at baseline, midline (1 year), and end line (3 years)
|
Children will be measured for their length (cm) among children 6 to 23 months of age.
The length measures will be used to create indices of length-for-age (LAZ) z-score based on the WHO child growth standards (WHO Multicentre Growth Reference Study Group 2006).
The prevalence of stunting (%) is defined as LAZ<-2.
The prevalence of stunting (%) among children 6-23 months of age in the WFP program versus comparison areas at midline (1 year) adjusting for the difference in the prevalence of stunting (%) at baseline between two areas will be a primary outcome at midline (1 year of program implementation).
The prevalence of stunting (%) among children 6-23 months of age in the WFP program versus comparison areas at endline (3 years), adjusting for the difference in the prevalence of stunting (%) at baseline between two areas will be a primary outcome at endline (3 years of program implementation).
|
Will assess at baseline, midline (1 year), and end line (3 years)
|
|
Change in the prevalence of wasting (%)
Time Frame: Will assess at baseline, midline (1 year), and end line (3 years)
|
Children will be measured for their length (cm) and weight (kg) among children 6 to 23 months of age.
The length and weight measures will be used to create indices of weight-for-length (WLZ) z-score based on the WHO child growth standards (WHO Multicentre Growth Reference Study Group 2006).
The prevalence of wasting (%) is defined as WLZ<-2.
The prevalence of wasting (%) among children 6-23 months of age in the WFP program versus comparison areas at midline (1 year) adjusting for the difference in the prevalence of wasting (%) at baseline between two areas will be a primary outcome at midline (1 year of program implementation).
The prevalence of wasting (%) among children 6-23 months of age in the WFP program versus comparison areas at endline (3 years), adjusting for the difference in the prevalence of wasting (%) at baseline between two areas will be a primary outcome at endline (3 years of program implementation).
|
Will assess at baseline, midline (1 year), and end line (3 years)
|
|
Change in the prevalence of underweight (%)
Time Frame: Will assess at baseline, midline (1 year), and end line (3 years)
|
Children will be measured for their weight (kg) among children 6 to 23 months of age.
The weight measures will be used to create indices of weight-for-age (WAZ) z-score based on the WHO child growth standards (WHO Multicentre Growth Reference Study Group 2006).
The prevalence of underweight (%) is defined as WAZ<-2.
The prevalence of underweight (%) among children 6-23 months of age in the WFP program versus comparison areas at midline (1 year) adjusting for the difference in the prevalence of underweight (%) at baseline between two areas will be a primary outcome at midline (1 year of program implementation).
The prevalence of underweight (%) among children 6-23 months of age in the WFP program versus comparison areas at endline (3 years), adjusting for the difference in the prevalence of underweight (%) at baseline between two areas will be a primary outcome at endline (3 years of program implementation).
|
Will assess at baseline, midline (1 year), and end line (3 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the prevalence of Iron Deficiency Anemia (IDA) (%)
Time Frame: Will assess at baseline and end line (3 years) among a subsample
|
Hemoglobin concentration (g/dl) will be assessed on a subsample of mothers and children and used to assess Iron Deficiency Anemia (IDA) (%).
The investigators will assess the differences in the IDA (%) among a subsample of mothers and children 6-23 months of age in the WFP program versus comparison areas at endline (3 years), adjusting for the difference in the IDA (%) at baseline between two areas.
|
Will assess at baseline and end line (3 years) among a subsample
|
|
Change in the proportion of caregiver knowledge and attitude about infant and young child feeding (IYCF) (%)
Time Frame: Will assess at baseline, midline (1 year), and end line (3 years)
|
The investigators will assess the IYCF knowledge and attitude (%) among caregivers of children 6-23 months of age.
The proportion of IYCF knowledge and attitude (%) among caregivers in the WFP program versus comparison areas at midline (1 year) adjusting for the difference in the prevalence of IYCF knowledge and attitude (%) at baseline between two areas will be a secondary outcome at midline (1 year of program implementation).
The proportion of IYCF knowledge and attitude (%) among caregivers in the WFP program versus comparison areas at endline adjusting for the difference in the prevalence of IYCF knowledge and attitude (%) at baseline between two areas will be a secondary outcome at endline (3 year of program implementation).
|
Will assess at baseline, midline (1 year), and end line (3 years)
|
|
Change in the proportion of caregiver knowledge, attitude and practice about infant and young child feeding (IYCF) (%)
Time Frame: Will assess at baseline, midline (1 year), and end line (3 years)
|
The investigators will assess the differences in the IYCF knowledge, attitude and practice (%) among caregivers of children 6-23 months of age in the WFP program versus comparison areas at midline (1 year) and at endline (3 years), adjusting for the difference in the IYCF knowledge, attitude, and practice at baseline between two areas.
|
Will assess at baseline, midline (1 year), and end line (3 years)
|
|
Change in caregiver practice about handwashing
Time Frame: Will assess at baseline, midline (1 year), and end line (3 years)
|
The investigators will assess the hand washing practice (%) among caregivers of children 6-23 months of age.
The proportion of hand washing practice (%) among caregivers in the WFP program versus comparison areas at midline (1 year) adjusting for the difference in the prevalence of hand washing practice %) at baseline between two areas will be a secondary outcome at midline (1 year of program implementation).
The proportion of hand washing practice (%) among caregivers in the WFP program versus comparison areas at endline adjusting for the difference in the prevalence of hand washing practice (%) at baseline between two areas will be a secondary outcome at endline (3 year of program implementation).
|
Will assess at baseline, midline (1 year), and end line (3 years)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kristen Hurley, PhD, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
General Publications
- 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.
- Kang Y, Hurley KM, Ruel-Bergeron J, Monclus AB, Oemcke R, Wu LSF, Mitra M, Phuka J, Klemm R, West KP, 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00005237
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Undernutrition
-
International Centre for Diarrhoeal Disease Research...CompletedModerate and Severe UndernutritionBangladesh
-
Gérond'ifRecruitingUndernutrition of Elderly PeopoleFrance
-
Gérond'ifTerminated
-
International Food Policy Research InstituteWithdrawnPoverty, Low Income, Food Insecurity, Undernutrition
-
Hopital ForcillesRecruiting
-
International Centre for Diarrhoeal Disease Research...Washington University School of MedicineRecruiting
-
Tufts UniversityHeifer Project InternationalCompleted
-
Centre Hospitalier Universitaire de Saint EtienneRegional Council of Auvergne-Rhône-Alpes; Bioparhom, FranceTerminated
-
University of Maryland, BaltimoreAssociation for the Study and Prevention of HIV/AIDSCompleted
-
Global Food & Nutrition Inc.International Partnership for Human Development; Alaska Seafood Marketing InstituteCompletedMalnutrition | Undernutrition
Clinical Trials on Nutributter
-
Tampere UniversityUniversity of California, Davis; Bill and Melinda Gates Foundation; Kamuzu University...Completed
-
Washington University School of MedicineUniversity of California, Davis; World Bank; United Nations World Food Programme...Completed