Tools to Improve Parental Recognition of Developmental Deficits in Children

Malnutrition Clinical Trial

Official title:

Tools to Improve Parental Recognition of Developmental Deficits in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242539
• Other study ID #: 14-2948
• Status: Completed
• Phase: N/A
• First received: September 12, 2014
• Last updated: January 11, 2016
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board of the Harvard School of Public HealthUnited States: Institutional Review Board of the Boston University Medical Campus, Panel BlueZambia: ERES Converge ethics committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 18 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Development
• Malnutrition

Intervention

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.
• 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.

Locations

Country	Name	City	State
Zambia	Household sample	Chipata District

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	Harvard University, Innovations for Poverty Action

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Mid-upper arm circumference (MUAC)	Children will be measured for mid-upper arm circumference (MUAC) using standard measurement strips	At the end of one year	No
Secondary	Dietary intake	Parents will be asked to report on children's dietary intake during the day preceding the survey	At the end of one year	No