Cognitive PerformanceNCT05498129
School Feeding to Improve Cognitive Performance in Disadvantaged Children
A study testing School meal, School meal plus micronutrient powder and No school meal in people with Cognitive Performance, run by University of Central Lancashire at 1 site in United Kingdom.
Trial summary
This trial investigated the impact of providing a regular meal with and without additional multiple micronutrients for children in Northwest Pakistan on their performance at school, in comparison to a local government school that served as a control i.e. no school meal. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance
- What is being tested?
- School meal, School meal plus micronutrient powder and No school meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2017to 1 Dec 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Prep or class 1
- Male/ female
Who cannot join
- Any contraindicating condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: School Feeding to Improve Cognitive Performance in Disadvantaged Children: A Randomized Controlled Trial in in Northwest Pakistan
This trial investigated the impact of providing a regular meal with and without additional multiple micronutrients for children in Northwest Pakistan on their performance at school, in comparison to a local government school that served as a control i.e. no school meal.
- Conditions
- Cognitive Performance
- Being tested
- School meal, School meal plus micronutrient powder, No school meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School mealOther
School lunch was comprised of rice, ghee and beef
School meal plus micronutrient powderOther
School lunch plus micronutrient powder
No school mealOther
No school meal
| Study group | Role | What they receive |
|---|---|---|
| No school meal | Active comparator | Not described Receives: Other: No school meal |
| School meal | Experimental | Not described Receives: Other: School meal |
| School meal plus micronutrient powder | Experimental | Not described Receives: Other: School meal plus micronutrient powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ravens Colour Matrices test for assessment of Cognitive function
Raven's Coloured Progressive Matrices. Raven's Coloured Progressive Matrices (RCPM) (20)is a widely used nonverbal intelligence test for children between the ages of 5 and 11 years. The test comprises 36-items in the form of three sets of 12 items, that increase in difficulty
Measured: Baseline
Ravens Colour Matrices test for assessment of Cognitive function
Raven's Coloured Progressive Matrices. Raven's Coloured Progressive Matrices (RCPM) (20)is a widely used nonverbal intelligence test for children between the ages of 5 and 11 years. The test comprises 36-items in the form of three sets of 12 items, that increase in difficulty
Measured: 6-months
Ravens Colour Matrices test for assessment of Cognitive function
Raven's Coloured Progressive Matrices. Raven's Coloured Progressive Matrices (RCPM) (20)is a widely used nonverbal intelligence test for children between the ages of 5 and 11 years. The test comprises 36-items in the form of three sets of 12 items, that increase in difficulty
Measured: 12-months
Secondary outcomes (7)
Height
Stature measured via a stadiometer
Measured: Baseline
Mass
Body mass using a weighing scale
Measured: Baseline
Mid upper arm circumference
Arm circumference
Measured: Baseline
Height for age
Height for age calculated using the WHO calculator based on the 2006 WHO Child Growth Standards.
Measured: Baseline
Weight for age
Weight for age calculated using the WHO calculator based on the 2006 WHO Child Growth Standards.
Measured: Baseline
Haemoglobin
Haemoglobin measured by finger prick blood samples
Measured: 6-months
Haemoglobin
Haemoglobin measured by finger prick blood samples
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Sep 2017
- Primary completion15 Jul 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber Medical University
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498129
- Sponsor's protocol ID
- School Feeding
- Status last verified
- Jan 2023
- First submitted
- 8 Aug 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Feeding to Improve Cognitive Performance in Disadvantaged Children: A Randomized Controlled Trial in in Northwest Pakistan
- ClinicalTrials.gov ID
- NCT05498129
- Acronym / sponsor ID
- School Feeding
- Conditions
- Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- Khyber Medical University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 11 Aug 2022 (actual)
- 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.
This trial investigated the impact of providing a regular meal with and without additional multiple micronutrients for children in Northwest Pakistan on their performance at school, in comparison to a local government school that served as a control i.e. no school meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No school meal | Active comparator | Other: No school meal |
| School meal | Experimental | Other: School meal |
| School meal plus micronutrient powder | Experimental | Other: School meal plus micronutrient powder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Prep or class 1
- Male/ female
Key exclusion criteria (1 listed)
- Any contraindicating condition
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 |
|---|---|---|
| School mealSchool lunch was comprised of rice, ghee and beef | Other | School meal |
| School meal plus micronutrient powderSchool lunch plus micronutrient powder | Other | School meal plus micronutrient powder |
| No school mealNo school meal | Other | No school meal |
Primary outcome
Ravens Colour Matrices test for assessment of Cognitive function
Time frame: Baseline
Raven's Coloured Progressive Matrices. Raven's Coloured Progressive Matrices (RCPM) (20)is a widely used nonverbal intelligence test for children between the ages of 5 and 11 years. The test comprises 36-items in the form of three sets of 12 items, that increase in difficulty
Ravens Colour Matrices test for assessment of Cognitive function
Time frame: 6-months
Raven's Coloured Progressive Matrices. Raven's Coloured Progressive Matrices (RCPM) (20)is a widely used nonverbal intelligence test for children between the ages of 5 and 11 years. The test comprises 36-items in the form of three sets of 12 items, that increase in difficulty
Ravens Colour Matrices test for assessment of Cognitive function
Time frame: 12-months
Raven's Coloured Progressive Matrices. Raven's Coloured Progressive Matrices (RCPM) (20)is a widely used nonverbal intelligence test for children between the ages of 5 and 11 years. The test comprises 36-items in the form of three sets of 12 items, that increase in difficulty
7 secondary outcomes
Height
Time frame: Baseline
Mass
Time frame: Baseline
Mid upper arm circumference
Time frame: Baseline
Height for age
Time frame: Baseline
Weight for age
Time frame: Baseline
Haemoglobin
Time frame: 6-months
Haemoglobin
Time frame: 12-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 18 Jan 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School meal, School meal plus micronutrient powder and No school meal in people with Cognitive Performance, run by University of Central Lancashire at 1 site in United Kingdom.
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 18 Jan 2023. 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 United Kingdom. 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?
Ravens Colour Matrices test for assessment of Cognitive function (time frame: Baseline). The study lists 3 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 18 Jan 2023.