MalnutritionNCT02242539
Tools to Improve Parental Recognition of Developmental Deficits in Children
A study testing Height measurement poster and Community-based monitoring in people with Malnutrition and Child Development, run by Boston University at 1 site in Zambia.
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… Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child Development
- What is being tested?
- Height measurement poster and Community-based monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 1 siteZambia
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All households with a child between the ages of 6 and 18 months at baseline
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Malnutrition, Child Development
- Being tested
- Height measurement poster, Community-based monitoring
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Height measurement posterBehavioural
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 monitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Height measurement poster | Experimental | Not described Receives: Behavioral: Height measurement poster |
| Community-based monitoring | Experimental | Not described Receives: Behavioral: Community-based monitoring |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At the end of one year
Secondary outcomes (2)
Mid-upper arm circumference (MUAC)
Children will be measured for mid-upper arm circumference (MUAC) using standard measurement strips
Measured: At the end of one year
Dietary intake
Parents will be asked to report on children's dietary intake during the day preceding the survey
Measured: At the end of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Innovations for Poverty Action
- Responsible party
- Principal investigator, Peter Rockers, Boston University
- Investigators
- Günther Fink, PhD, Principal investigator, Harvard UniversityPeter Rockers, ScD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242539
- Sponsor's protocol ID
- 14-2948
- Status last verified
- Jan 2016
- First submitted
- 12 Sep 2014
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28835364
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tools to Improve Parental Recognition of Developmental Deficits in Children
- ClinicalTrials.gov ID
- NCT02242539
- Acronym / sponsor ID
- 14-2948
- Conditions
- Malnutrition, Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Harvard University, Innovations for Poverty Action
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Height measurement poster | Experimental | Behavioral: Height measurement poster |
| Community-based monitoring | Experimental | Behavioral: Community-based monitoring |
| Control | No intervention | – |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All households with a child between the ages of 6 and 18 months at baseline
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Height measurement posterEach 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. | Behavioural | Height measurement poster |
| Community-based monitoringOnce 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. | Behavioural | Community-based monitoring |
Primary outcome
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
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
2 secondary outcomes
Mid-upper arm circumference (MUAC)
Time frame: At the end of one year
Dietary intake
Time frame: At the end of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Derived from this study: PubMed 28835364Fink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Günther Fink, PhD principal investigator
Harvard University
Peter Rockers, ScD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Height measurement poster and Community-based monitoring in people with Malnutrition and Child Development, run by Boston University at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height-for-age z-score (time frame: At the end of one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02242539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.