Evaluation of School-based Nutrition Intervention for Adolescents in Bangladesh

Anemia Clinical Trial

— SNAP  

Official title:

Evaluation of a Package of Nutrition Interventions to School-based Nutrition and Health Intervention for Adolescents in Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455073
• Other study ID #: NI-02-2019-SNAP
• Status: Completed
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2022
• Source: Nutrition International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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' 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3018
• Est. completion date: February 28, 2022
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Menstrual Hygiene Management

Intervention

Dietary Supplement:
• Weekly Iron and Folic Acid Supplementation (WIFA)
Weekly school provision of WIFA tablets to adolescent girls

Combination Product:
• WASH
Ensure availability (or provision) of water, sanitation, and hygiene supplies for adolescent girls and boys
• 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
• MHM & WASH Behavior Change Intervention (BCI)
Changing the knowledge, attitudes, and practices of WASH and menstrual hygiene management

Locations

Country	Name	City	State
Canada	Nutrition International	Ottawa	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Nutrition International	CDC Foundation, Centers for Disease Control and Prevention, Directorate of Secondary and Higher Education, Ministry of Education, Bangladesh, Institute of Public Health and Nutrition, Ministry of Health and Family Welfare, Bangladesh

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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