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AnemiaSNAPNCT05455073

Evaluation of School-based Nutrition Intervention for Adolescents in Bangladesh

A study testing Weekly Iron and Folic Acid Supplementation (WIFA), WASH and Menstrual Hygiene Management in people with Anemia and Menstrual Hygiene Management, run by Nutrition International at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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'… Read more about this study

Who is it for?
Ages 10 to 19 yearsHealthy volunteers can take part
What is being tested?
Weekly Iron and Folic Acid Supplementation (WIFA), WASH and Menstrual Hygiene Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,018 participants
Where
1 siteCanada
Study dates
31 Jul 2019to 28 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • Girl or boy enrolled in grades other than grades 8 or 9
  • Enrolled after random selection of participants

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Nutrition International

    Ottawa, Ontario, K2P2K3

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Weekly Iron and Folic Acid Supplementation (WIFA), WASH, Menstrual Hygiene Management, Nutrition Behavior Change Intervention (BCI), MHM & WASH Behavior Change Intervention (BCI)
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weekly Iron and Folic Acid Supplementation (WIFA)Dietary supplement

    Also called Behavior Change Intervention

    Weekly school provision of WIFA tablets to adolescent girls

  • WASHCombination product

    Ensure availability (or provision) of water, sanitation, and hygiene supplies for adolescent girls and boys

  • Menstrual Hygiene ManagementCombination product

    Support for adolescent girls' menstrual hygiene

  • Nutrition Behavior Change Intervention (BCI)Behavioural

    Changing the knowledge, attitudes, and practices of nutrition (including dietary diversity), IFA, deworming

  • MHM & WASH Behavior Change Intervention (BCI)Behavioural

    Changing the knowledge, attitudes, and practices of WASH and menstrual hygiene management

Study groups in NCT05455073
Study groupRoleWhat they receive
Full package intervention armExperimental* 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)
Receives: Dietary Supplement: Weekly Iron and Folic Acid Supplementation (WIFA); Combination Product: WASH; Combination Product: Menstrual Hygiene Management; Behavioral: Nutrition Behavior Change Intervention (BCI); Behavioral: MHM & WASH Behavior Change Intervention (BCI)
Limited package intervention armExperimental* 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
Receives: Dietary Supplement: Weekly Iron and Folic Acid Supplementation (WIFA); Behavioral: Nutrition Behavior Change Intervention (BCI)
ControlNo interventionNo intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin concentration and anemia prevalence among adolescent girls

    Assessment of hemoglobin concentration and anemia prevalence among adolescent girls, using HemoCue® Hb-301 photometer

    Measured: Up to 12 months

  2. Iron and folate status, iron deficiency and folate insufficiency among adolescent girls

    1. 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

    Measured: Up to 12 months

  3. Decrease morbidity among adolescents due to improved water, sanitation and hygiene (WASH) behaviour.

    Recall of morbidity symptoms over the past 3 days

    Measured: Up to 12 months

  4. Decrease barriers to menstrual hygiene management (MHM) for adolescent girls and thereby improve their school attendance

    In-school subsidized purchase of sanitary pads for menstruating girls

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start31 Jul 2019
  3. Primary completion22 Mar 2021
  4. Study completion28 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,018 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05455073
Sponsor's protocol ID
NI-02-2019-SNAP
Acronym
SNAP
Status last verified
Apr 2022
First submitted
6 Apr 2022
Last updated
13 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Demuyakor ME, Jalal C, Williams AM, Bouckaert KP, Whitehead RD Jr, Bhuiyan MM, Siraj S, Ara R, Pike V, Jefferds MED. Design, Methods, and Select Baseline Results from a School Nutrition Project for Adolescents in Bangladesh. Curr Dev Nutr. 2023 Mar 30;7(4):100070. doi: 10.1016/j.cdnut.2023.100070. eCollection 2023 Apr.

    PubMed 37304846

Questions about this trial

What is this clinical trial studying?

A study testing Weekly Iron and Folic Acid Supplementation (WIFA), WASH and Menstrual Hygiene Management in people with Anemia and Menstrual Hygiene Management, run by Nutrition International at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin concentration and anemia prevalence among adolescent girls (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05455073, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.

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