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Tools to Improve Parental Recognition of Developmental Deficits in Children

Primary Purpose

Malnutrition, Child Development

Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Height measurement poster
Community-based monitoring
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition

Eligibility Criteria

6 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Household sample

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Height measurement poster

Community-based monitoring

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mid-upper arm circumference (MUAC)
Children will be measured for mid-upper arm circumference (MUAC) using standard measurement strips
Dietary intake
Parents will be asked to report on children's dietary intake during the day preceding the survey

Full Information

First Posted
September 12, 2014
Last Updated
January 11, 2016
Sponsor
Boston University
Collaborators
Harvard University, Innovations for Poverty Action
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1. Study Identification

Unique Protocol Identification Number
NCT02242539
Brief Title
Tools to Improve Parental Recognition of Developmental Deficits in Children
Official Title
Tools to Improve Parental Recognition of Developmental Deficits in Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University
Collaborators
Harvard University, Innovations for Poverty Action

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child Development

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Height measurement poster
Arm Type
Experimental
Arm Title
Community-based monitoring
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Height measurement poster
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community-based monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Height-for-age z-score
Description
Children's heights will be measured and height-fore-age z-scores will be determined using standards published by the World Health Organization
Time Frame
At the end of one year
Title
Child development outcomes
Description
Through parental reports and child tasks we will measure various aspects of child development, including motor skills and verbal skills
Time Frame
At the end of one year
Secondary Outcome Measure Information:
Title
Mid-upper arm circumference (MUAC)
Description
Children will be measured for mid-upper arm circumference (MUAC) using standard measurement strips
Time Frame
At the end of one year
Title
Dietary intake
Description
Parents will be asked to report on children's dietary intake during the day preceding the survey
Time Frame
At the end of one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All households with a child between the ages of 6 and 18 months at baseline Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Günther Fink, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Rockers, ScD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Household sample
City
Chipata District
Country
Zambia

12. IPD Sharing Statement

Citations:
PubMed Identifier
28835364
Citation
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.
Results Reference
derived

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Tools to Improve Parental Recognition of Developmental Deficits in Children

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