Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-03 @ 7:14 PM
Study NCT ID:
NCT02985359
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact Evaluation of the WFP-Implemented Nutrition Program in Malawi
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Study Overview
Official Title:
Impact Evaluation of the WFP-Implemented Nutrition Program in Malawi
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: