NCT01763502

Brief Summary

Recent evidence shows that early childhood is a critical period for investments in human capital and that micronutrient deficiency and inadequate stimulation are major causes of impaired child development in poor countries. These findings have increased interest in promoting nutrition interventions and preschool participation during early childhood. Transfers to households linked to preschool participation have the potential to improve nutrition and cognitive outcomes in young children. Receipt of transfers may induce improvements in diet quality and greater preschool participation, enhancing both nutrition and stimulation. However, there is limited evidence on the impacts of such programs, all of it from Latin America. There is also no evidence on the relative impact of different transfer modalities linked to preschool participation. This study is a cluster-randomized controlled evaluation of a transfer program linked to preschool participation. The transfer program, administered by the World Food Programme, provides food or cash transfers to children aged 3-5 years enrolled in preschools at baseline. The preschools, operating in the Karamoja sub-region of Uganda, are supported by UNICEF and managed by District representatives of the Government of Uganda. The food transfers consist of multiple-micronutrient-fortified corn soy blend (CSB), oil, and sugar, totaling approximately 1200 calories per day per child and including 99% of iron requirements. Cash transfers equal the estimated value of the food basket if purchased in the market. Randomization into the food treatment, cash treatment or control was done across 98 preschools, referred to as Early Childhood Development (ECD) centers. The intervention period was from February 2011 to May 2012 and included distribution of transfers on a six-to-eight-week cycle. A longitudinal (panel) survey of households with children aged 3-5 years at baseline was conducted before exposure to the transfers and 18 months later. The randomized design of this effectiveness study and the panel nature of the data allow for a rigorous field trial in which impacts on nutrition and cognitive outcomes can be assessed and compared across modalities. We examine the impacts of the two transfer modalities, cash transfers or multiple-micronutrient-fortified food transfers, linked to preschool enrollment, on child nutrition and cognitive development. In addition, we explore potential mechanisms through intermediate impacts on food intake and participation in preschools. The key research objectives are to assess the following:

  1. 1.Impacts on targeted groups: Assess the effects of cash or food transfers on nutrition and cognitive outcomes in children aged 3-5 years at baseline and explore pathways for these effects.
  2. 2.Optimal program design: Assess the differential impacts of a program in which children are provided multiple-micronutrient-fortified food transfers linked to preschool enrollment compared with one in which they are given the equivalent value of cash transfers linked to preschool enrollment.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,561

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

January 3, 2013

Last Update Submit

January 4, 2013

Conditions

Keywords

Cognitive developmentAnemiaPreschoolFood transfersCash transfersEarly childhoodNutrition

Outcome Measures

Primary Outcomes (2)

  • Cognitive development scores at 18 months after baseline

    Mullens total raw score, visual reception domain score, fine motor domain score, receptive language domain score, expressive language domain score

    March-May, 2012: 18 months after baseline

  • Anemia incidence at 18 months after baseline

    Mild anemia (hemoglobin concentration \< 11•0 g/dL); moderate to severe anemia (hemoglobin concentration \< 9•0 g/dL)

    March-May, 2012: 18 months after baseline

Secondary Outcomes (1)

  • Anthropometry at 18 months after baseline

    March-May, 2012: 18 months after baseline

Study Arms (3)

FOOD

EXPERIMENTAL

Food transfer linked to preschool enrollment

Other: FOOD

CASH

EXPERIMENTAL

Cash transfer linked to preschool enrollment

Other: CASH

CTRL

NO INTERVENTION

No transfer linked to preschool enrollment

Interventions

FOODOTHER

The food transfers consist of multiple-micronutrient-fortified corn soy blend (CSB), oil, and sugar, totaling approximately 1200 calories per day per child and including 99% of iron requirements.

FOOD
CASHOTHER

Cash transfers equal the estimated value of the food basket if purchased in the market.

CASH

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 3-5 years
  • Enrolled in ECD centers funded by UNICEF at baseline

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNICEF early childhood development centers

Karamoja Sub-region, Uganda

Location

MeSH Terms

Conditions

Anemia

Interventions

Food

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Daniel Gilligan, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR
  • Shalini Roy, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral fellow, Poverty Health and Nutrition Division

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 9, 2013

Study Start

August 1, 2010

Primary Completion

May 1, 2012

Last Updated

January 9, 2013

Record last verified: 2013-01

Locations