NCT05455073

Brief 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' 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,018

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

July 31, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
Last Updated

July 13, 2022

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

April 6, 2022

Last Update Submit

July 8, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Hemoglobin concentration and anemia prevalence among adolescent girls

    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

    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.

    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

    In-school subsidized purchase of sanitary pads for menstruating girls

    Up to 12 months

Study Arms (3)

Full package intervention arm

EXPERIMENTAL

* 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)Combination Product: WASHCombination Product: Menstrual Hygiene ManagementBehavioral: Nutrition Behavior Change Intervention (BCI)Behavioral: MHM & WASH Behavior Change Intervention (BCI)

Limited package intervention arm

EXPERIMENTAL

* 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)Behavioral: Nutrition Behavior Change Intervention (BCI)

Control

NO INTERVENTION

No intervention.

Interventions

Weekly school provision of WIFA tablets to adolescent girls

Also known as: Behavior Change Intervention
Full package intervention armLimited package intervention arm
WASHCOMBINATION_PRODUCT

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

Full package intervention arm
Menstrual Hygiene ManagementCOMBINATION_PRODUCT

Support for adolescent girls' menstrual hygiene

Full package intervention arm

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

Full package intervention armLimited package intervention arm

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

Full package intervention arm

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition International

Ottawa, Ontario, K2P2K3, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

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

Study Record Dates

First Submitted

April 6, 2022

First Posted

July 13, 2022

Study Start

July 31, 2019

Primary Completion

March 22, 2021

Study Completion

February 28, 2022

Last Updated

July 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations