NCT03263377

Brief Summary

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. 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,006

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2016

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
Last Updated

August 28, 2017

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

June 5, 2016

Last Update Submit

August 23, 2017

Conditions

Keywords

School feedingFortified BiscuitsBangladesh

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline Children's weight at 14 months

    Children's weight were measured by WHO

    Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)

  • Change from Baseline Children's Height at 14 months

    Children's Height were measured by WHO

    Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)

  • Change from Baseline Children's nutritional impact at 14 months

    Child anaemia and micronutrient deficiency: biochemical analyses of blood specimens

    Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)

Secondary Outcomes (1)

  • Change from Baseline Children's cognitive performance and school attendance at 14 months

    Double time point (Baseline, September, 2011 and Endline, November, 2012; through study completion)

Study Arms (2)

2

ACTIVE COMPARATOR

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. The school feeding intervention consists of a daily snack in the form of a fortified biscuit that provides 300 kcal per single 75 gm packet (approximately 15% of daily calorie requirements), and a range of micronutrients contributing to about 75% of the daily requirement of vitamin A, folate, iron, iodine, zinc and magnesium. Children whose cognitive abilities are are challenged by autism, mental issues or iodine deficiency will be excluded from the study.

Dietary Supplement: The school feeding intervention

Non Intervention

OTHER

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. An equal number of boys and girls will be selected from each class to enable gender analysis. Children whose cognitive abilities are are challenged by autism, mental issues or iodine deficiency will be excluded from the study.No intervention had given in this group.

Dietary Supplement: The school feeding intervention

Interventions

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. The school feeding intervention consists of a daily snack in the form of a fortified biscuit that provides 300 kcal per single 75 gm packet (approximately 15% of daily calorie requirements), and a range of micronutrients contributing to about 75% of the daily requirement of vitamin A, folate, iron, iodine, zinc and magnesium.

2Non Intervention

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of school children
  • Giving Consent

You may not qualify if:

  • More than 12 years of age
  • Refuse consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Powell CA, Walker SP, Chang SM, Grantham-McGregor SM. Nutrition and education: a randomized trial of the effects of breakfast in rural primary school children. Am J Clin Nutr. 1998 Oct;68(4):873-9. doi: 10.1093/ajcn/68.4.873.

  • Simeon DT. School feeding in Jamaica: a review of its evaluation. Am J Clin Nutr. 1998 Apr;67(4):790S-794S. doi: 10.1093/ajcn/67.4.790S.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2016

First Posted

August 28, 2017

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

August 28, 2017

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share