- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242539
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
-
-
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Chipata District, Zambia
- Household sample
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-
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
|
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
|
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
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At the end of one year
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Child development outcomes
Time Frame: At the end of one year
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Through parental reports and child tasks we will measure various aspects of child development, including motor skills and verbal skills
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At the end of one year
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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
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At the end of one year
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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
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.
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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