Cognitive DevelopmentNCT01763502
The Impact of Cash and Food Transfers Linked to Preschool Enrollment on Child Nutrition and Cognitive Outcomes
A study testing FOOD and CASH in people with Cognitive Development and Anemia, run by International Food Policy Research Institute at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Development, Anemia
- What is being tested?
- FOOD and CASH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,561 participants
- Where
- 1 siteUganda
- Study dates
- Aug 2010to May 2012
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 3-5 years
- Enrolled in ECD centers funded by UNICEF at baseline
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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:
- 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.
- 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.
Read the detailed description
Allocation: Randomized
This evaluation is conducted in communities surrounding Early Childhood Development (ECD) centers in the Karamoja sub-region of Uganda, in Napak, Kotido, and Kaabong districts. The catchment area of ECD centers serve as the clusters for randomization and analysis. After stratifying ECD centers (by district for Napak and Kotido, and by sub-district for the more spatially-diverse Kaabong), clusters were assigned to the treatment groups (FOOD, CASH and CTRL) using block randomization, to ensure as equal a distribution of ECD centers across treatment arms within each stratum as possible. Block randomization yielded 33 ECD centers in the FOOD group, 32 centers in the CASH group, and 33 centers in the CTRL group. Subsequently but prior to the start of the interventions, WFP re-assigned one CTRL center to FOOD, due to its proximity to a nearby FOOD center, in order to avoid migration of children which posed contamination concerns. WFP also re-assigned one CASH center to FOOD, because the cash distribution systems required use of mobile phones, and mobile phone signals were not readily available in the center's catchment area. The final assignment included 35 ECD centers in the FOOD group, 31 centers in the CASH group, and 32 centers in the CTRL group.
Statistical Analysis:
- Sample Selection and Sample Size: Prior to the baseline survey, power calculations were conducted using existing data from Uganda on cognitive measures (Mullens scores) and food security measures (share of food expenditures out of total expenditures) to estimate the necessary sample size for detecting a minimum effect size of 10 percentage points with 80 percent power. These calculations indicated a target minimum sample of 30 ECD centers per treatment arm and 20 households per ECD center. 98 ECD center clusters were determined eligible for transfer receipt by WFP. ECD enrollment data collected in August-September, 2010, were used to identify households with children ages 3-5 years enrolled in these ECD centers. In each of the 98 ECD centers, out of all households with children ages 3-5 years enrolled, roughly 25 households were selected at random for inclusion in the baseline sample.
- Data Collection: The evaluation uses a longitudinal design, with the same households interviewed at baseline (September-November, 2010, prior to start of the food or cash program) and at endline (March-May, 2012). In the intervening months, treatment households receive 15 months of exposure to the intervention. Direct assessments of children's cognitive development, anthropometry, and hemoglobin levels are conducted in a randomly-selected roughly 80% of sampled households in each cluster, due to field time constraints. Cognitive development is assessed using a battery of test items drawn primarily from the Mullen Scales of Early Learning, adapted by psychologists for the Karamoja context. Anthropometry is measured following standard protocol using height boards and weighing scales. Hemoglobin concentration is assessed using capillary blood obtained by finger prick and read using a HemoCue® analyzer. Hemoglobin readings are adjusted as necessary for the effects of varying altitude in the sample.
- Analysis: Differences in baseline characteristics are assessed using pairwise t-tests and binomial probability tests. Analyses of impacts focus on outcomes for children age 3-5 years (36-71 months) at baseline, as well as for children aged 36-53 months at baseline who remain in the targeted age range throughout the course of the intervention. Intent to treat (ITT) effects are estimated using single-difference and ANCOVA specifications on children at baseline and endline. Estimates are calculated using Stata 12; standard errors account for stratification and clustering in sampling and assignment.
Ethics Review:
- Side Effects: Potential risks from participation in this study are low. Many of the questions used in the survey have been used before in the Uganda National Household Survey. Cognitive tests consist of simple games played between a trained enumerator and the child and are unlikely to pose any risk to the children. Anthropometry measurements are non-invasive and also pose no risk. Risks associated with hemoglobin data collection are minimized through use of well-trained staff, a well-designed data collection protocol, and safety lancets. The study poses no social, emotional, or psychological risks to subjects.
- Health provisions: If any child is found to be severely anemic (Hb<7 g/dL) or wasted (weight-for-height less than two standard deviations below the mean), that child and the child's parents are notified and the child is referred to the nearest clinic for medical treatment.
- Informed consent: Details about the study are provided verbally to local leaders at the LC1 (roughly the equivalent of a village) level. The same information, including the right to opt out at any time, is provided verbally to survey respondents in sampled households. Additional informed consent is sought before each direct interaction with children, including for cognitive tests, anthropometry, and hemoglobin measurement.
- IRB: This study underwent internal review with the International Food Policy Research Institute; permission to conduct the data collection was granted by Uganda National Council for Science and Technology (SS 2470).
Funding:
This evaluation was funded by the World Food Programme, with support from the Spanish government and other sources through the Strategic Impact Evaluation Trust Fund at WFP, and by the United Nations Children's Fund.
- Conditions
- Cognitive Development, Anemia
- Being tested
- FOOD, CASH
- Keywords
- Cognitive development, Anemia, Preschool, Food transfers, Cash transfers, Early childhood, Nutrition
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
CASHOther
Cash transfers equal the estimated value of the food basket if purchased in the market.
| Study group | Role | What they receive |
|---|---|---|
| FOOD | Experimental | Food transfer linked to preschool enrollment Receives: Other: FOOD |
| CASH | Experimental | Cash transfer linked to preschool enrollment Receives: Other: CASH |
| CTRL | No intervention | No transfer linked to preschool enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: March-May, 2012: 18 months after baseline
Secondary outcomes (1)
Anthropometry at 18 months after baseline
Prevalence of stunting; prevalence of underweight; prevalence of wasting
Measured: March-May, 2012: 18 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startAug 2010
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DevelopmentStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,561 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United Nations World Food Programme (WFP), UNICEF
- Responsible party
- Principal investigator, Shalini Roy, International Food Policy Research Institute
- Investigators
- Daniel Gilligan, PhD, Principal investigator, International Food Policy Research InstituteShalini Roy, PhD, Principal investigator, International Food Policy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763502
- Sponsor's protocol ID
- 1004649
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2013
- Last updated
- 9 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cash and Food Transfers Linked to Preschool Enrollment on Child Nutrition and Cognitive Outcomes
- ClinicalTrials.gov ID
- NCT01763502
- Acronym / sponsor ID
- 1004649
- Conditions
- Cognitive Development, Anemia
- Keywords
- Cognitive development, Anemia, Preschool, Food transfers, Cash transfers, Early childhood, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,561 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- United Nations World Food Programme (WFP), UNICEF
- Study start
- Aug 2010
- Primary completion
- May 2012 (actual)
- First posted
- 9 Jan 2013 (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.
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:
- 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.
- 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.
Detailed description
Allocation: Randomized
This evaluation is conducted in communities surrounding Early Childhood Development (ECD) centers in the Karamoja sub-region of Uganda, in Napak, Kotido, and Kaabong districts. The catchment area of ECD centers serve as the clusters for randomization and analysis. After stratifying ECD centers (by district for Napak and Kotido, and by sub-district for the more spatially-diverse Kaabong), clusters were assigned to the treatment groups (FOOD, CASH and CTRL) using block randomization, to ensure as equal a distribution of ECD centers across treatment arms within each stratum as possible. Block randomization yielded 33 ECD centers in the FOOD group, 32 centers in the CASH group, and 33 centers in the CTRL group. Subsequently but prior to the start of the interventions, WFP re-assigned one CTRL center to FOOD, due to its proximity to a nearby FOOD center, in order to avoid migration of children which posed contamination concerns. WFP also re-assigned one CASH center to FOOD, because the cash distribution systems required use of mobile phones, and mobile phone signals were not readily available in the center's catchment area. The final assignment included 35 ECD centers in the FOOD group, 31 centers in the CASH group, and 32 centers in the CTRL group.
Statistical Analysis:
- Sample Selection and Sample Size: Prior to the baseline survey, power calculations were conducted using existing data from Uganda on cognitive measures (Mullens scores) and food security measures (share of food expenditures out of total expenditures) to estimate the necessary sample size for detecting a minimum effect size of 10 percentage points with 80 percent power. These calculations indicated a target minimum sample of 30 ECD centers per treatment arm and 20 households per ECD center. 98 ECD center clusters were determined eligible for transfer receipt by WFP. ECD enrollment data collected in August-September, 2010, were used to identify households with children ages 3-5 years enrolled in these ECD centers. In each of the 98 ECD centers, out of all households with children ages 3-5 years enrolled, roughly 25 households were selected at random for inclusion in the baseline sample.
- Data Collection: The evaluation uses a longitudinal design, with the same households interviewed at baseline (September-November, 2010, prior to start of the food or cash program) and at endline (March-May, 2012). In the intervening months, treatment households receive 15 months of exposure to the intervention. Direct assessments of children's cognitive development, anthropometry, and hemoglobin levels are conducted in a randomly-selected roughly 80% of sampled households in each cluster, due to field time constraints. Cognitive development is assessed using a battery of test items drawn primarily from the Mullen Scales of Early Learning, adapted by psychologists for the Karamoja context. Anthropometry is measured following standard protocol using height boards and weighing scales. Hemoglobin concentration is assessed using capillary blood obtained by finger prick and read using a HemoCue® analyzer. Hemoglobin readings are adjusted as necessary for the effects of varying altitude in the sample.
- Analysis: Differences in baseline characteristics are assessed using pairwise t-tests and binomial probability tests. Analyses of impacts focus on outcomes for children age 3-5 years (36-71 months) at baseline, as well as for children aged 36-53 months at baseline who remain in the targeted age range throughout the course of the intervention. Intent to treat (ITT) effects are estimated using single-difference and ANCOVA specifications on children at baseline and endline. Estimates are calculated using Stata 12; standard errors account for stratification and clustering in sampling and assignment.
Ethics Review:
- Side Effects: Potential risks from participation in this study are low. Many of the questions used in the survey have been used before in the Uganda National Household Survey. Cognitive tests consist of simple games played between a trained enumerator and the child and are unlikely to pose any risk to the children. Anthropometry measurements are non-invasive and also pose no risk. Risks associated with hemoglobin data collection are minimized through use of well-trained staff, a well-designed data collection protocol, and safety lancets. The study poses no social, emotional, or psychological risks to subjects.
- Health provisions: If any child is found to be severely anemic (Hb<7 g/dL) or wasted (weight-for-height less than two standard deviations below the mean), that child and the child's parents are notified and the child is referred to the nearest clinic for medical treatment.
- Informed consent: Details about the study are provided verbally to local leaders at the LC1 (roughly the equivalent of a village) level. The same information, including the right to opt out at any time, is provided verbally to survey respondents in sampled households. Additional informed consent is sought before each direct interaction with children, including for cognitive tests, anthropometry, and hemoglobin measurement.
- IRB: This study underwent internal review with the International Food Policy Research Institute; permission to conduct the data collection was granted by Uganda National Council for Science and Technology (SS 2470).
Funding:
This evaluation was funded by the World Food Programme, with support from the Spanish government and other sources through the Strategic Impact Evaluation Trust Fund at WFP, and by the United Nations Children's Fund.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FOOD | Experimental | Other: FOODFood transfer linked to preschool enrollment |
| CASH | Experimental | Other: CASHCash transfer linked to preschool enrollment |
| CTRL | No intervention | –No transfer linked to preschool enrollment |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 3-5 years
- Enrolled in ECD centers funded by UNICEF 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 |
|---|---|---|
| FOODThe 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. | Other | FOOD |
| CASHCash transfers equal the estimated value of the food basket if purchased in the market. | Other | CASH |
Primary outcome
Cognitive development scores at 18 months after baseline
Time frame: March-May, 2012: 18 months after baseline
Mullens total raw score, visual reception domain score, fine motor domain score, receptive language domain score, expressive language domain score
Anemia incidence at 18 months after baseline
Time frame: March-May, 2012: 18 months after baseline
Mild anemia (hemoglobin concentration < 11•0 g/dL); moderate to severe anemia (hemoglobin concentration < 9•0 g/dL)
1 secondary outcome
Anthropometry at 18 months after baseline
Time frame: March-May, 2012: 18 months after baseline
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 9 Jan 2013.
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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.
Daniel Gilligan, PhD principal investigator
International Food Policy Research Institute
Shalini Roy, PhD principal investigator
International Food Policy Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOOD and CASH in people with Cognitive Development and Anemia, run by International Food Policy Research Institute at 1 site in Uganda.
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 2 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 9 Jan 2013. 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 Uganda. 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?
Cognitive development scores at 18 months after baseline (time frame: March-May, 2012: 18 months after baseline). 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?
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 9 Jan 2013.