- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05455073
Evaluation of School-based Nutrition Intervention for Adolescents in Bangladesh (SNAP)
July 8, 2022 updated by: Nutrition International
Evaluation of a Package of Nutrition Interventions to School-based Nutrition and Health Intervention for Adolescents in Bangladesh
Addressing the nutrition needs of adolescents could be an important initiative for breaking the vicious cycle of intergenerational malnutrition, chronic diseases and poverty.
To respond to these diverse needs of adolescents, the Government of Bangladesh (GoB) in 2012, instituted a national policy for adolescent girls' weekly iron and folic acid (WIFA) supplementation in secondary schools to reduce anemia.
Efforts are in place to roll out a national WIFA supplementation program for both in-school and out-of-school adolescent girls aged 10-19 years.
Responding to the need to demonstrate the feasibility of such a new initiative before it is scaled-up, Nutrition International (NI) with funding support from the Government of Canada committed to providing technical and financial support to demonstrate to the GoB, the feasibility of a school-based delivery of nutrition interventions to improve the nutrition and health status of adolescents in Joypurhat and Sirajganj districts of Bangladesh.
The project developed and began roll out of a multi-sectorial holistic and integrated nutrition approach consisting of both a nutrition-specific and nutrition-sensitive program model for improving the general health and nutrition of adolescents in schools.
This was delivered in an integrated package for girls and boys including WIFA supplementation (girls only), promotion of improved water, sanitation and hygiene (WASH), behavior change interventions (BCI) on all topics, and support for menstrual hygiene management (MHM) for girls, including sale of menstrual products in schools.
To evaluate the program, the GoB (Institute of Public Health and Nutrition, Ministry of Health and Family Welfare (IPHN) and The Directorate of Secondary and Higher Education, Ministry of Education (DSHE) and NI with technical assistance from the CDC Foundation and CDC planned process and outcome evaluations for the first year of the program's implementation.
Study Overview
Status
Completed
Detailed Description
The outcome evaluation was a school (cluster)-based, randomized controlled trial with three equal size intervention arms, sampling adolescents, teachers, and student leaders in 75 selected schools.
The study investigated the impact of the school-based program implemented in Joypurhat and aimed to examine the effectiveness and factors influencing scalability of using the secondary school platform to deliver WIFA co-packaged with WASH, MHM, and BCI to improve the nutrition and health status of adolescents in Bangladesh.
The process evaluation sampled adolescents, teachers, and student leaders from 12 schools selected through convenience sampling for qualitative interviews, and determined whether the school-based program was implemented as intended, and why and how the intervention components worked to produce an impact - specifically, assessing the level of adherence.
Study Type
Interventional
Enrollment (Actual)
3018
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
-
-
Ontario
-
Ottawa, Ontario, Canada, K2P2K3
- Nutrition International
-
-
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
10 years to 19 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Randomly selected adolescent girl or boy
- Present on the day(s) of the survey
- Verbal assent and parental/guardian written consent
- School level headteacher, assigned teacher or student leader in the various grades
Exclusion Criteria:
- Girl or boy enrolled in grades other than grades 8 or 9
- Enrolled after random selection of participants
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control
No intervention.
|
|
|
EXPERIMENTAL: Full package intervention arm
|
Weekly school provision of WIFA tablets to adolescent girls
Other Names:
Ensure availability (or provision) of water, sanitation, and hygiene supplies for adolescent girls and boys
Support for adolescent girls' menstrual hygiene
Changing the knowledge, attitudes, and practices of nutrition (including dietary diversity), IFA, deworming
Changing the knowledge, attitudes, and practices of WASH and menstrual hygiene management
|
|
EXPERIMENTAL: Limited package intervention arm
|
Weekly school provision of WIFA tablets to adolescent girls
Other Names:
Changing the knowledge, attitudes, and practices of nutrition (including dietary diversity), IFA, deworming
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemoglobin concentration and anemia prevalence among adolescent girls
Time Frame: Up to 12 months
|
Assessment of hemoglobin concentration and anemia prevalence among adolescent girls, using HemoCue® Hb-301 photometer
|
Up to 12 months
|
|
Iron and folate status, iron deficiency and folate insufficiency among adolescent girls
Time Frame: Up to 12 months
|
a) Iron status and inflammation was assessed using a sandwich ELISA method, including 2 indicators of iron status (ferritin, sTfR) and 2 indicators of inflammation (C-reactive protein (CRP) and alpha 1-acid glycoprotein (AGP)); b) Folate status was assessed using a microbiological assay to test for red blood cell (RBC) folate and serum folate
|
Up to 12 months
|
|
Decrease morbidity among adolescents due to improved water, sanitation and hygiene (WASH) behaviour.
Time Frame: Up to 12 months
|
Recall of morbidity symptoms over the past 3 days
|
Up to 12 months
|
|
Decrease barriers to menstrual hygiene management (MHM) for adolescent girls and thereby improve their school attendance
Time Frame: Up to 12 months
|
In-school subsidized purchase of sanitary pads for menstruating girls
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
July 31, 2019
Primary Completion (ACTUAL)
March 22, 2021
Study Completion (ACTUAL)
February 28, 2022
Study Registration Dates
First Submitted
April 6, 2022
First Submitted That Met QC Criteria
July 8, 2022
First Posted (ACTUAL)
July 13, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 13, 2022
Last Update Submitted That Met QC Criteria
July 8, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI-02-2019-SNAP
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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