Malnutrition Clinical Trial
Official title:
The Impact on School Feeding on Children's Growth and Development
In order to improve child nutrition, the Poverty Reduction Strategy adopted by the Government
of Bangladesh (GoB) has called for the initiation of a school feeding programme for primary
school children living in poor and disadvantaged families and communities where the
prevalence of child malnutrition is high. Accordingly, a pilot feeding programme is planned
for implementation in Government and NGO schools in 10 Upazilas in rural Bangladesh with the
aim of: 1) enhancing the nutritional status and growth of younger school-going children by
reducing micronutrient deficiencies and providing a protein/calorie supplement; 2) improving
learning capacity and attentiveness in the classroom; 3) increasing enrollment, attendance
and completion rates and 4) supporting the goals of achieving universal primary education and
reducing gender disparity.
The objectives of the proposed baseline survey respond to GoB's aims:
1. To assess the nutrition status of younger school-going children prior to the initiation
of a school feeding programme, thus enabling the later assessment of programme impact on
micronutrient deficiencies and anthropometric indicators.
2. To assess the cognitive performance and school attendance of children prior to the
initiation of a school feeding programme thus enabling the later assessment of programme
impact on school enrollment and attendance, and learning capacity.
The baseline study will be conducted using a cluster randomized study design in which schools
represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10
that have been selected for intervention. A control group will be included in study design
consisting of 7 schools selected randomly from 7 comparable yet adjacent Upazilas not slated
for inclusion in the feeding programme. Use of a control group will enable later evaluations
to attribute possible improvements in key impact/outcome variables to the intervention
itself. A mid term evaluation will be conducted 6 months after the baseline survey. Finally,
an impact evaluation will be conducted on the same children 10-14 months after the baseline
survey.
To enable useful comparison, FSNSP will adapt the study design used by World Food Programme
to evaluate a similar school feeding intervention undertaken in chronically food insecure
areas in rural Bangladesh during the period 2002-04. The baseline study will be conducted
using a cluster randomized study design in which schools represent clusters. Seven schools
will be randomly selected from each of 7 Upazilas out of 10 that have been selected for
intervention. A control group will be included in study design consisting of 7 schools
selected randomly from 7 comparable yet adjacent Upazilas not slated for inclusion in the
feeding programme. Control groups will share the same socio-economic, geographic background
characteristics of adjacent intervention schools, but are located in Upazilas that have not
been selected by GoB to be part of the pilot School Feeding Programme. Use of a control group
will enable later evaluations to attribute possible improvements in key impact/outcome
variables to the intervention itself. A mid-term followup and endline study will be conducted
on the same children approximately 6 months and 10-12 months following baseline. The precise
timing of follow-up will be a function of when biscuit distribution is initiated, and
seasonal period. Care will be taken to capture the same season as the baseline (to control
for seasonal availability of fruits and vegetables), and to ensure that follow-up occurs
before the Ramadan period when normal food consumption patterns are disrupted.
The baseline study will consist of data collected at individual (child), household (mother)
and institutional (school) levels. Study methods will include: 1) a structured survey
questionnaire delivered to teachers, school children, and their mothers; 2) In-depth
interviews/focus groups with teachers, community members and NGO implementers; 3) data
abstraction from school records; 4) anthropometric and cognitive measures of all primary
school students, and 5) biological measures on a sub-sample of children. Programme staff will
be consulted in the design and piloting of study instruments, and in thinking about how to
best accommodate monitoring and evaluation activities into project design.
7. Structured Surveys The student survey questionnaire will comprise of a series of questions
that assess what they have eaten recently, as well perceptions of satiety, hunger, energy
levels, ability to concentrate, and whether there have been recent school absences.
The mother's questionnaire will cover background information concerning household food
security and socio-economic status, as well as information on the child's eating practices,
recent morbidity, and personal assessment of child's energy level, concentration and
irritability.
A teacher's questionnaire queries their perceptions and experience in the classroom regarding
the behavior of children in the classroom.
8. In-depth Interviews In-depth interviews with teachers, school officials and NGO
implementer will be undertaken to assess attitudes, expectations and plans regarding the
school feeding program (in intervention schools only), and whether any other school-based
nutrition or health programmes had ever been implemented in the area.
9. School Records Information on school infrastructure (toilet, water supply), schedules,
management structures (school committees) will be collected, and data on school attendance,
and enrollment (over the past 3 years), will be extracted from school records.
10. Anthropometry and Cognitive Measures Following the administration of the student survey,
measures of height and weight will be taken on each child interviewed, and a short cognitive
test "Raven's Matrices" will be administered.
Weight of the children will be measured to the nearest 100 g using a digital scale. Height of
the child will be determined with a locally constructed instrument in which a plastic tape
measure is extended between a footplate and head bar. Height will be measured within 0.1 cm.
The mean of three consecutive measurements (height and weight) will be considered as the
observed value. This will be done during data analysis. All measurements will subsequently be
compared to the standards according to the WHO 2006 growth standards and the nutritional
status will be assessed by z-score. All anthropometric measurements will be performed by
trained and experienced field workers following standard procedures.
Raven's Progressive Matrices (often referred to simply as Raven's Matrices) are non-verbal
multiple choice measures of the reasoning (or, better, "meaning-making") component of
Spearman's g, which is often referred to as general intelligence. The tests were originally
developed by John C. Raven in 1936. In each test item, the subject is asked to identify the
missing element that completes a pattern. Many patterns are presented in the form of a 4x4,
3x3, or 2x2 matrix, giving the test its name.
It is developed based on simple measures of the two main components of Spearman's g viz. (1)
the ability to think clearly and make sense of complexity, which is known as eductive ability
(from the Latin root "educere", meaning "to draw out") and (2) the ability to store and
reproduce information, known as reproductive ability.
Raven's CPM is designed for young children ages 5:0-11:0 years and older adults. The test
consists of 36 items in 3 sets (A, Ab, B), with 12 items per set arranged to assess the chief
cognitive processes of which children under 11 years of age are usually capable. The CPM
items are arranged to assess cognitive development up to the stage when a person is
sufficiently able to reason by analogy and adopt this way of thinking as a consistent method
of inference.
The Raven's CPM produces a single raw score that can be converted to a percentile based on
normative data collected from various groups.
Although RAVEN was developed for research purposes, because of its independence of language
and reading and writing skills, and simplicity of use and interpretation, it has found
widespread application internationally (10,11). RAVEN has been deployed successfully among
young children in Bangladesh (personal communication with Jena Hamadani, Fahmida Tofail), and
Bengali training guides have been developed.
11. Biochemical Measures, Assessments of haemoglobin, Other biochemical tests will be
performed on a separate portion of blood (1.5 mL). These include: Assessments of C-reative
protein. Assessments of serum ferritin, Assessments of retinol Assessments of folic acid,
Assessments of Vitamin B12, We also use pool serum as internal quality control. We
participate CDC vital EQA program for serum vitamin B12
Assessments of Zinc, Assessments of 25-Hydroxy Vitamin, Assessments of urinary iodine
Sampling technique To enroll a sufficiently sized random sample of eligible school children,
we will obtain lists of children in Classes 1-3 from the school authority. Participating
school children will be selected randomly from these lists through computer-generated random
numbers. An equal number of boys and girls will be selected from each class to enable gender
analysis. Schoolteachers will assist in identifying and contacting all randomly-selected
children and their mothers at household level. In the case of a school child who is randomly
selected but is not present at the school due to illness, dropout etc., the subsequent child
on class list will be selected. Children whose cognitive abilities are are challenged by
autism, mental issues or iodine deficiency will be excluded from the study.
Assuming a mean weight of 22.4 kg (SD=3.0 kg); and SFP is expected to increase the mean
weight from 22.4 kg to 24.0 kg, thus to detect a difference of 1.6 kg with 90% power and type
I error=0.05, design effect=2.0 and 10% drop-outs, the necessary sample-size calculated to be
at least 164 school children in each group. This is less than the sample size required for
BMI.
For collection of blood and urine sample we will first randomly select a school from the
upazila school list. Than again randomization will be performed for selection of children for
specimen collection from the study participating children of that school.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT03268902 -
Early Life Interventions for Childhood Growth and Development In Tanzania
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
| Completed |
NCT04608656 -
Livestock for Health Project
|
N/A | |
| Completed |
NCT06009198 -
Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan
|
N/A | |
| Recruiting |
NCT05417672 -
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
|
||
| Recruiting |
NCT05257980 -
Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial
|
N/A | |
| Completed |
NCT05015647 -
Low Protein Diet in CKD Patients at Risk of Malnutrition
|
N/A | |
| Completed |
NCT03628196 -
A Nutrition-Focused QIP in Outpatient Clinics
|
||
| Enrolling by invitation |
NCT04675229 -
Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
|
||
| Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
| Not yet recruiting |
NCT05860556 -
Sustainable Eating Pattern to Limit Malnutrition in Older Adults
|
||
| Not yet recruiting |
NCT06047054 -
Incidence Rate and Risk Factors of Malnutrition in ICU
|
||
| Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 | |
| Not yet recruiting |
NCT04183075 -
Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
|
N/A | |
| Not yet recruiting |
NCT03150927 -
Clinical Study of Novel Probiotic Microbial Composite⢠to Treat Undernourished Young Children
|
N/A | |
| Recruiting |
NCT03408067 -
Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients
|
N/A | |
| Recruiting |
NCT02833740 -
Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition
|
N/A | |
| Completed |
NCT02938247 -
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake
|
N/A | |
| Completed |
NCT02938234 -
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake
|
N/A |