NCT02242539

Brief Summary

In this study, we aim to improve child nutrition by increasing parents' awareness of their children's physical growth. We use a cluster-randomized trial design to evaluate two interventions that provide parents with regular information on their children's physical development and growth: 1) distribution of full-sized growth charts for measurement of child height within households; and 2) organization of community-based meetings, during which children's height and weight are measured by trained project staff.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
547

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

September 12, 2014

Last Update Submit

January 11, 2016

Conditions

MalnutritionChild Development

Outcome Measures

Primary Outcomes (2)

  • Height-for-age z-score

    Children's heights will be measured and height-fore-age z-scores will be determined using standards published by the World Health Organization

    At the end of one year

  • Child development outcomes

    Through parental reports and child tasks we will measure various aspects of child development, including motor skills and verbal skills

    At the end of one year

Secondary Outcomes (2)

  • Mid-upper arm circumference (MUAC)

    At the end of one year

  • Dietary intake

    At the end of one year

Study Arms (3)

Height measurement poster

EXPERIMENTAL
Behavioral: Height measurement poster

Community-based monitoring

EXPERIMENTAL
Behavioral: Community-based monitoring

Control

NO INTERVENTION

Interventions

Height measurement posterBEHAVIORAL

Each household is provided with a poster which study personnel help to hang on the wall. The poster clearly indicates height-for-age benchmarks and stunting cut-offs for study-age children. Parents are provided training on how to measure their children at regular intervals, and interpret height readings to determine whether their child is developing normally or is stunted.

Height measurement poster
Community-based monitoringBEHAVIORAL

Once every three months, villages are visited by study staff who measure children's heights and weights, and parents are informed if their children are below the reference measures established by the World Health Organization. If a child's weight is such that the child is classified as severely malnourished, the child is referred to the nearest health center for treatment. If the child is stunted (height-for-age z-score more than 2 standard deviations below the reference median), we provide parents with a supply of "Yummy Soy" powder, a fortified soy and maize mix popular among parents and widely available in local super markets. Parents are instructed to give one or two tea spoons of the mix to the child each day.

Community-based monitoring

Eligibility Criteria

Age6 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All households with a child between the ages of 6 and 18 months at baseline

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Household sample

Chipata District, Zambia

Location

Related Publications (1)

  • Fink G, Levenson R, Tembo S, Rockers PC. Home- and community-based growth monitoring to reduce early life growth faltering: an open-label, cluster-randomized controlled trial. Am J Clin Nutr. 2017 Oct;106(4):1070-1077. doi: 10.3945/ajcn.117.157545. Epub 2017 Aug 23.

    PMID: 28835364DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Günther Fink, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

  • Peter Rockers, ScD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 17, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

ZA(1)