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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3018

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control
No intervention.
EXPERIMENTAL: Full package intervention arm
  • Dietary Supplement of Weekly Iron and Folic Acid (WIFA) Supplementation (containing 60 mg of elemental iron and 2800 µg of folic acid) and;
  • Associated behavior change intervention (BCI) to change the knowledge, attitudes, and practices of nutrition (including dietary diversity), IFA, deworming
  • Water, sanitation and hygiene (WASH) intervention: ensure availability (or provision) of water, sanitation, and hygiene supplies
  • Menstrual hygiene management (MHM) intervention: support for menstrual hygiene, including sale of menstrual products in schools
  • Associated behavior change intervention (BCI) to change the knowledge, attitudes, and practices (KAP) of WASH and menstrual hygiene management (MHM)
Dietary supplement: Weekly Iron and Folic Acid Supplementation (WIFA)
Weekly school provision of WIFA tablets to adolescent girls
Other Names:
  • Behavior Change Intervention
Combination product: WASH
Ensure availability (or provision) of water, sanitation, and hygiene supplies for adolescent girls and boys
Combination product: Menstrual Hygiene Management
Support for adolescent girls' menstrual hygiene
Behavioral: Nutrition Behavior Change Intervention (BCI)
Changing the knowledge, attitudes, and practices of nutrition (including dietary diversity), IFA, deworming
Behavioral: MHM & WASH Behavior Change Intervention (BCI)
Changing the knowledge, attitudes, and practices of WASH and menstrual hygiene management
EXPERIMENTAL: Limited package intervention arm
  • Dietary Supplement of Weekly Iron and Folic Acid (WIFA) Supplementation (containing 60 mg of elemental iron and 2800 µg of folic acid; weekly school provision of WIFA tablets) and;
  • Associated behavior change intervention (BCI) to change the knowledge, attitudes, and practices of nutrition (including dietary diversity), IFA, deworming
Dietary supplement: Weekly Iron and Folic Acid Supplementation (WIFA)
Weekly school provision of WIFA tablets to adolescent girls
Other Names:
  • Behavior Change Intervention
Behavioral: Nutrition Behavior Change Intervention (BCI)
Changing the knowledge, attitudes, and practices of nutrition (including dietary diversity), IFA, deworming

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutrition International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention
CDC Foundation
Institute of Public Health and Nutrition, Ministry of Health and Family Welfare, Bangladesh
Directorate of Secondary and Higher Education, Ministry of Education, Bangladesh

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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