NCT02985359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

June 24, 2016

Last Update Submit

August 15, 2017

Conditions

Keywords

Program impact evaluationMalawiLipid-based nutrient supplementsSocial behavior change communicationChildhood stunting

Outcome Measures

Primary Outcomes (3)

  • 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).

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

  • 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).

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

  • 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).

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

Secondary Outcomes (4)

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

    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) (%)

    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) (%)

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

  • Change in caregiver practice about handwashing

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

Study Arms (2)

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.

Dietary Supplement: NutributterBehavioral: Social Behavioral Change Communication (SBCC)

Interventions

NutributterDIETARY_SUPPLEMENT

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

Also known as: Lipid-based nutrient supplement
Program district

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.

Program district

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wadonda Consult Ltd

Zomba, Malawi

Location

Related Publications (2)

  • 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 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of Dried Blood Spots

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Kristen Hurley, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 24, 2016

First Posted

December 7, 2016

Study Start

January 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations