MalnutritionNCT01261182
Targeting School Feeding Programs at Vulnerable Sub-Groups
A study testing In School Feeding and Take Home Rations in people with Malnutrition and Cognition, run by International Food Policy Research Institute at 2 sites in Uganda.
Trial summary
School feeding programs provide students meals conditional on school attendance, which can have impacts on school participation, cognition and learning, and nutritional outcomes. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Malnutrition, Cognition
- What is being tested?
- In School Feeding and Take Home Rations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,083 participants
- Where
- 2 sitesUganda
- Study dates
- Start not givento not given
- 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 13 years
- All sexes
- Child
Who may be able to join
- School age children
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of School Feeding Programs' Impact on Anemia Status in Pre-adolescent Girls and Other Vulnerable Household Members in a Cluster-Randomized Trial in Uganda
School feeding programs provide students meals conditional on school attendance, which can have impacts on school participation, cognition and learning, and nutritional outcomes. Although the literature on impacts of school feeding programs is substantial, high quality studies with evaluation designs that provide causal impact estimates are relatively few. Thus program impacts on educational, cognitive and nutritional outcomes are not well-understood, particularly in a field setting. Nutritional impacts in particular are questionable, which may be a result program design. Most studies provide only small transfers to children and examine average macro-nutrient effects of the transfer on the treated children, thus it is not surprising that detection of nutritional gains has been minimal.
This study is a cluster-randomized evaluation of a school feeding program administered by the World Food Programme in the Northern Ugandan Districts of Lira and Pader. The program provides substantially larger food rations than most programs (representing 1/3 of children's daily caloric needs and 99% of iron intake requirements).
Read more
The key research objectives are:
- Impact on the treated: Assess the effectiveness of the program at improving nutritional status, education and cognitive and learning outcomes for school-age children, with particular attention to the anemia status of older school-age girls .
- Impact on untreated but nutritionally vulnerable sub-groups: Assess the effectiveness of the program at reducing anemia prevalence in mothers and younger siblings.
- Optimal program design: Assess the differential impacts of a program in which children are fed at school compared with one in which they are given dry rations to bring home.
- Conditions
- Malnutrition, Cognition
- Being tested
- In School Feeding, Take Home Rations
- Keywords
- Malnutrition, School feeding, Infant nutrition, Mother's nutrition, Fortified food, Anemia, Cluster randomized controlled trials, Effectiveness, Impact evaluation studies, Uganda
- Medical subject headings
- Malnutrition, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In School FeedingOther
The intervention provides meals consisting of 1049 kcals of energy, 32.6 gm protein, and 24.9 gm fat per child per school day and meet at least two thirds of the child's daily vitamin and mineral requirements, including 99 percent of iron requirements. SFP delivers these nutrients in the form of a fortified corn-soy porridge around mid-morning and beans and maize meal or rice at lunch.
Take Home RationsOther
The rations provided in the intervention are equal in size and composition to the food received in the in-school feeding intervention, but are provided to households once per month.
| Study group | Role | What they receive |
|---|---|---|
| In School Feeding | Experimental | Not described Receives: Other: In School Feeding |
| Take Home Rations | Experimental | Not described Receives: Other: Take Home Rations |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers' and Children's Nutritional Status
Measured: 15 months
Secondary outcomes (3)
Cognitive Performance
Measured: 15 months
School achievement
Measured: 15 months
School Participation
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
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.
- 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
- 2,083 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, World Bank, United Nations World Food Programme (WFP), UNICEF
- Investigators
- Marie Ruel, PhD, Principal investigator, IFPRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261182
- Sponsor's protocol ID
- WB-7135830
- Status last verified
- Dec 2010
- First submitted
- 14 Dec 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Adelman S, Gilligan DO, Konde-Lule J, Alderman H. School Feeding Reduces Anemia Prevalence in Adolescent Girls and Other Vulnerable Household Members in a Cluster Randomized Controlled Trial in Uganda. J Nutr. 2019 Apr 1;149(4):659-666. doi: 10.1093/jn/nxy305.
PubMed 30926996
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of School Feeding Programs' Impact on Anemia Status in Pre-adolescent Girls and Other Vulnerable Household Members in a Cluster-Randomized Trial in Uganda
- ClinicalTrials.gov ID
- NCT01261182
- Acronym / sponsor ID
- WB-7135830
- Conditions
- Malnutrition, Cognition
- Keywords
- Malnutrition, School feeding, Infant nutrition, Mother's nutrition, Fortified food, Anemia, Cluster randomized controlled trials, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,083 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Makerere University, World Bank, United Nations World Food Programme (WFP), UNICEF
- First posted
- 16 Dec 2010 (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.
School feeding programs provide students meals conditional on school attendance, which can have impacts on school participation, cognition and learning, and nutritional outcomes. Although the literature on impacts of school feeding programs is substantial, high quality studies with evaluation designs that provide causal impact estimates are relatively few. Thus program impacts on educational, cognitive and nutritional outcomes are not well-understood, particularly in a field setting. Nutritional impacts in particular are questionable, which may be a result program design. Most studies provide only small transfers to children and examine average macro-nutrient effects of the transfer on the treated children, thus it is not surprising that detection of nutritional gains has been minimal.
This study is a cluster-randomized evaluation of a school feeding program administered by the World Food Programme in the Northern Ugandan Districts of Lira and Pader. The program provides substantially larger food rations than most programs (representing 1/3 of children's daily caloric needs and 99% of iron intake requirements).
The key research objectives are:
- Impact on the treated: Assess the effectiveness of the program at improving nutritional status, education and cognitive and learning outcomes for school-age children, with particular attention to the anemia status of older school-age girls .
- Impact on untreated but nutritionally vulnerable sub-groups: Assess the effectiveness of the program at reducing anemia prevalence in mothers and younger siblings.
- Optimal program design: Assess the differential impacts of a program in which children are fed at school compared with one in which they are given dry rations to bring home.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In School Feeding | Experimental | Other: In School Feeding |
| Take Home Rations | Experimental | Other: Take Home Rations |
| Control | No intervention | – |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- School age children
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| In School FeedingThe intervention provides meals consisting of 1049 kcals of energy, 32.6 gm protein, and 24.9 gm fat per child per school day and meet at least two thirds of the child's daily vitamin and mineral requirements, including 99 percent of iron requirements. SFP delivers these nutrients in the form of a fortified corn-soy porridge around mid-morning and beans and maize meal or rice at lunch. | Other | In School Feeding |
| Take Home RationsThe rations provided in the intervention are equal in size and composition to the food received in the in-school feeding intervention, but are provided to households once per month. | Other | Take Home Rations |
Primary outcome
Mothers' and Children's Nutritional Status
Time frame: 15 months
3 secondary outcomes
Cognitive Performance
Time frame: 15 months
School achievement
Time frame: 15 months
School Participation
Time frame: 15 months
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 16 Dec 2010.
- Derived from this study: PubMed 30926996Adelman S, Gilligan DO, Konde-Lule J, Alderman H. School Feeding Reduces Anemia Prevalence in Adolescent Girls and Other Vulnerable Household Members in a Cluster Randomized Controlled Trial in Uganda. J Nutr. 2019 Apr 1;149(4):659-666. doi: 10.1093/jn/nxy305.
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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.
Marie Ruel, PhD principal investigator
IFPRI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In School Feeding and Take Home Rations in people with Malnutrition and Cognition, run by International Food Policy Research Institute at 2 sites 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 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 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Mothers' and Children's Nutritional Status (time frame: 15 months). 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 NCT01261182, 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 16 Dec 2010.