NCT04116593

Brief Summary

The investigators hypothesize that school-based nutrition education will increase dietary diversity among the adolescent girls. The investigators propose a matched, pair-cluster randomized controlled trial to measure the efficacy of school-based nutrition education on dietary diversity of the adolescent girls in Bangladesh. This study will have two arms (one intervention and one control arm). After screening, based on exclusion criteria, the investigators will prepare two separate lists (one for urban and one for rural) of schools in Rangpur district. From each list, clusters (schools) will be paired based on monthly tuition fees provided by the students (as a proxy indicator of socio-economic status of the students) and infrastructure of the schools. The investigators will randomly select one pair from each list and within each pair one school will be assigned to intervention arm and another one will be assigned to control arm through randomization. Targeting an effect size of 20 percentage point reduction of inadequate dietary diversity, a minimum of 148 adolescent girls will be required for each arm. Eleven to fifteen years old adolescent girls studying in grade six, seven and eight will be recruited from each school. To ensure household level participation and support, caregivers will be invited to the school for a discussion at the beginning of the intervention. Nutritional education will be delivered using audio-visual techniques (audio-visual presentation) once in a week for each class, for 3 months. Individual (IDDS) and household dietary diversity scores (HDDS) will be used for measuring dietary diversity at individual and household level, respectively. IDDS and HDDS data will be collected at recruitment, at the end of education intervention and again after 3 months of the completion of intervention. Following national guidelines, weekly iron-folic acid (IFA) supplementation will be provided to both intervention and control arm for 3 months. For identifying the barriers to and facilitators of intake of diversified food, a qualitative research will be conducted after the intervention. Adolescent girls having improved and girls showing no improvement in individual dietary diversity score will be recruited purposively for the qualitative assessment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
296

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 31, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

September 30, 2019

Last Update Submit

March 29, 2022

Conditions

Keywords

Nutrition educationDietary diversityAdolescent girls

Outcome Measures

Primary Outcomes (1)

  • Changes in the percentage of dietary diversity (based on different food groups) from baseline.

    Primary outcome of the intervention trial will be individual level dietary diversity among the adolescent girls. Dietary diversity will be measured by a 24-hour recall questionnaire.

    At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention

Secondary Outcomes (6)

  • Changes in weight (in kg) from baseline

    At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention

  • Changes in height (in meter) from Baseline

    At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention

  • Changes in Mid Upper Arm Circumference (in cm) from baseline

    At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention

  • Changes in hemoglobin concentration from baseline

    At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention

  • Changes in Body Mass Index (BMI) from baseline

    At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Nutrition education

Control

NO INTERVENTION

Interventions

Our intervention will be school based nutrition education.Nutrition education session will be delivered using audio-visual techniques (audio-visual presentation).Components of eight educational sessions will include overview of 16 food groups of individual dietary diversity score (IDDS) chart, detail description of 16 food groups presenting dietary diversity, overview of basic food components, importance of consuming diversified foods, strategies to select a diversified meal and remove monotony in food, proper timing and frequency of taking meals during 24 hours, selecting diversified meal in low expense, consequences of absence or scarcity of dietary diversity in meal.

Intervention

Eligibility Criteria

Age11 Years - 15 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGirls are the future mothers and adolescent malnutrition is directly related to poor reproductive health outcome in future. Moreover, from previous studies it is seen that maternal height is directly related to offspring's height but paternal height is not related to offspring's growth. We cannot increase height of a mother because Linear growth spurt lasts 24-26 months during early adolescence and final adult weight \& height gain will cease after early adolescence. So, adolescence is the last opportunity to intervene and break the vicious cycle of inter-generational malnutrition and as we cannot increase a mother's height, we have to go down to the life cycle and put intervention at early adolescence among adolescent girls.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Never married adolescent school girls studying in grade six, seven and eight (age range 11-15) at the selected schools
  • Household(s) belong to selected study participants
  • Girl(s) willing to give assent

You may not qualify if:

  • Adolescent girls who are \< 11 years and \> 15 years
  • Presence of any kind of chronic disease among study participants
  • Presence of any major psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Secondary Schools in Rangpur

Rangpur City, Bangladesh

RECRUITING

Related Publications (1)

  • Nyma Z, Rahman M, Das S, Alam MA, Haque E, Ahmed T. Dietary diversity modification through school-based nutrition education among Bangladeshi adolescent girls: A cluster randomized controlled trial. PLoS One. 2023 Mar 8;18(3):e0282407. doi: 10.1371/journal.pone.0282407. eCollection 2023.

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 4, 2019

Study Start

January 15, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 31, 2022

Record last verified: 2022-01

Locations