Tools to Improve Parental Recognition of Developmental Deficits in Children

January 11, 2016 updated by: Peter Rockers, Boston University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The target population for the study will be children between the ages of 6 and 18 months at baseline living in small-scale farming households in Chipata District, Zambia. As part of a cluster-randomized trial titled "Food Constraints, Yield Uncertainty and 'Ganyu' Labor" funded by IZA-DFID (PI: G Fink), 3,100 farming households in approximately 180 rural villages in Eastern Province are currently enrolled in a two-year study, which aims at assessing the effect of food loan programs on agricultural productivity. The study described here uses the "Food Constraints" population as a sampling frame; all households enrolled in the "Food Constraints" program that have a child between 6 and 18 months are invited to participate in this add-on trial. We anticipate that there will be around 600 eligible households recruited for this study. Study duration is about 18 months. Selected households will be visited for study enrollment and a short baseline assessment in September 2014, at which time the two interventions will also be rolled out. Final impact of the interventions will be assessed one year later, in September 2015.

Study Type

Interventional

Enrollment (Actual)

547

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Chipata District, Zambia
        • Household sample

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Height measurement poster
Behavioral: Height measurement poster
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.
Experimental: Community-based monitoring
Behavioral: Community-based monitoring
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height-for-age z-score
Time Frame: At the end of one year
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
Time Frame: At the end of one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mid-upper arm circumference (MUAC)
Time Frame: At the end of one year
Children will be measured for mid-upper arm circumference (MUAC) using standard measurement strips
At the end of one year
Dietary intake
Time Frame: At the end of one year
Parents will be asked to report on children's dietary intake during the day preceding the survey
At the end of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

Harvard University
Innovations for Poverty Action

Investigators

  • Principal Investigator: Günther Fink, PhD, Harvard University
  • Principal Investigator: Peter Rockers, ScD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-2948

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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