Clinical trial NCT05455073: Evaluation of School-based Nutrition Intervention for Adolescents in Bangladesh
Official title: Evaluation of a Package of Nutrition Interventions to School-based Nutrition and Health Intervention for Adolescents in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Menstrual Hygiene Management
Improved Water, Sanitation and Hygiene (WASH)
Lead sponsor: Nutrition International
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: CDC Foundation
name: Institute of Public Health and Nutrition, Ministry of Health and Family Welfare, Bangladesh
name: Directorate of Secondary and Higher Education, Ministry of Education, Bangladesh
First posted: 2022-07-13
Enrollment: 3018
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin concentration and anemia prevalence among adolescent girls
timeFrame: Up to 12 months
measure: Iron and folate status, iron deficiency and folate insufficiency among adolescent girls
timeFrame: Up to 12 months
measure: Decrease morbidity among adolescents due to improved water, sanitation and hygiene (WASH) behaviour.
timeFrame: Up to 12 months
measure: Decrease barriers to menstrual hygiene management (MHM) for adolescent girls and thereby improve their school attendance
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Nutrition International
state: Ontario
Study officials:
References: