- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05498129
School Feeding to Improve Cognitive Performance in Disadvantaged Children
January 13, 2023 updated by: Jonathan Sinclair, University of Central Lancashire
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lancashire
-
Preston, Lancashire, United Kingdom, PR4 0PE
- Jonathan Sinclair
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Prep or class 1
- Male/ female
Exclusion Criteria:
- Any contraindicating condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: No school meal
|
No school meal
|
Experimental: School meal
|
School lunch was comprised of rice, ghee and beef
|
Experimental: School meal plus micronutrient powder
|
School lunch plus micronutrient powder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
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
|
6-months
|
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
|
12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Height
Time Frame: Baseline
|
Stature measured via a stadiometer
|
Baseline
|
Mass
Time Frame: Baseline
|
Body mass using a weighing scale
|
Baseline
|
Mid upper arm circumference
Time Frame: Baseline
|
Arm circumference
|
Baseline
|
Height for age
Time Frame: Baseline
|
Height for age calculated using the WHO calculator based on the 2006 WHO Child Growth Standards.
|
Baseline
|
Weight for age
Time Frame: Baseline
|
Weight for age calculated using the WHO calculator based on the 2006 WHO Child Growth Standards.
|
Baseline
|
Haemoglobin
Time Frame: 6-months
|
Haemoglobin measured by finger prick blood samples
|
6-months
|
Haemoglobin
Time Frame: 12-months
|
Haemoglobin measured by finger prick blood samples
|
12-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
July 15, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
August 8, 2022
First Submitted That Met QC Criteria
August 10, 2022
First Posted (Actual)
August 11, 2022
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- School Feeding
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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