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UndernutritionNCT02985359

Impact Evaluation of the WFP-Implemented Nutrition Program in Malawi

An observational study of Undernutrition, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for
Undernutrition
What is being tested?
Nutributter and Social Behavioral Change Communication (SBCC)
How many people
556 participants
Where
1 siteMalawi
Study dates
Jan 2014to May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Malawi1 site

  • Wadonda Consult Ltd

    Zomba

Other trials in Malawi

About this study

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.

Read the 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).
Conditions
Undernutrition
Being tested
Nutributter, Social Behavioral Change Communication (SBCC)
Keywords
Program impact evaluation, Malawi, Lipid-based nutrient supplements, Social behavior change communication, Childhood stunting
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NutributterDietary supplement

    Also called Lipid-based nutrient supplement

    Daily 20g Nutributter provided to children 6 to 24 month of age

  • Social Behavioral Change Communication (SBCC)Behavioural

    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.

Study groups in NCT02985359
Study groupRoleWhat they receive
Comparison districtExisting routine community health services by government
Program districtIn 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.
Receives: Dietary Supplement: Nutributter; Behavioral: Social Behavioral Change Communication (SBCC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the prevalence of stunting (%)

    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).

    Measured: Will assess at baseline, midline (1 year), and end line (3 years)

  2. Change in the prevalence of wasting (%)

    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).

    Measured: Will assess at baseline, midline (1 year), and end line (3 years)

  3. Change in the prevalence of underweight (%)

    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).

    Measured: Will assess at baseline, midline (1 year), and end line (3 years)

Secondary outcomes (4)

  1. Change in the prevalence of Iron Deficiency Anemia (IDA) (%)

    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.

    Measured: Will assess at baseline and end line (3 years) among a subsample

  2. Change in the proportion of caregiver knowledge and attitude about infant and young child feeding (IYCF) (%)

    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).

    Measured: Will assess at baseline, midline (1 year), and end line (3 years)

  3. Change in the proportion of caregiver knowledge, attitude and practice about infant and young child feeding (IYCF) (%)

    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.

    Measured: Will assess at baseline, midline (1 year), and end line (3 years)

  4. Change in caregiver practice about handwashing

    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).

    Measured: Will assess at baseline, midline (1 year), and end line (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study startJan 2014
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02985359
Sponsor's protocol ID
00005237
Status last verified
Aug 2017
First submitted
24 Jun 2016
Last updated
18 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 33742208

  • 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.

    PubMed 30378520

Questions about this trial

What is this clinical trial studying?

An observational study of Undernutrition, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Malawi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the prevalence of stunting (%) (time frame: Will assess at baseline, midline (1 year), and end line (3 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02985359, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.

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