Clinical trial NCT02242539: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Child Development
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Innovations for Poverty Action
First posted: 2014-09-17
Enrollment: 547
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Height-for-age z-score
timeFrame: At the end of one year
measure: Child development outcomes
timeFrame: At the end of one year
Secondary outcomes:
measure: Mid-upper arm circumference (MUAC)
timeFrame: At the end of one year
measure: Dietary intake
timeFrame: At the end of one year
Other outcomes:
Locations:
city: Chipata District
country: Zambia
facility: Household sample
Study officials:
affiliation: Harvard University
name: Günther Fink, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Peter Rockers, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.