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School-Based Nutrition Education in Improving Dietary Diversity Among Adolescent Girls

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ClinicalTrials.gov Identifier: NCT04116593
Recruitment Status : Not yet recruiting
First Posted : October 4, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Nutritional Deficiency Behavioral: Nutrition education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Cluster Randomized Controlled Trial to Measure the Efficacy of School-Based Nutrition Education in Improving Dietary Diversity Among Bangladeshi Adolescent Girls
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: Intervention Behavioral: Nutrition education
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.

No Intervention: Control



Primary Outcome Measures :
  1. Changes in the percentage of dietary diversity (based on different food groups) from baseline. [ Time Frame: At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention ]
    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.


Secondary Outcome Measures :
  1. Changes in weight (in kg) from baseline [ Time Frame: At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention ]
    Weight of the study participants will be measured by portable electronic weighting scale (TANITA Corporation Japan).

  2. Changes in height (in meter) from Baseline [ Time Frame: At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention ]
    Height will be measured by Seca stadiometer.

  3. Changes in Mid Upper Arm Circumference (in cm) from baseline [ Time Frame: At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention ]
    Mid upper-arm circumference (MUAC) will be measured at the midpoint of the left upper arm (extended with the palm facing inwards) between the acromion process and the tip of the olecranon, using a plastic non-stretchable tape to the nearest millimeter

  4. Changes in hemoglobin concentration from baseline [ Time Frame: At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention ]
    Hemoglobin status will be measured from a finger prick blood sample using a HemoCue machine (Hb 301, HemoCue AB, Angelholm, Sweden).

  5. Changes in Body Mass Index (BMI) from baseline [ Time Frame: At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention ]
    Weight and height will be used for computing BMI. BMI below 18.5 is referred to as underweight, 18.5-24.9 as normal range, 25.0-29.9 as overweight and 30.0 and above as obese.

  6. Changes in height-for-age z-score from baseline [ Time Frame: At the end of intervention (after 3 months of intervention) and after 3 months of the completion of intervention ]
    Weight and height will be used for computing height-for-age z-score.Height-for-age z-score <-2SD will be considered as stunted.



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Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Girls 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.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116593


Contacts
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Contact: Mahfuzur Rahman, MPH +880-2-9827001-10 ext 2594 mahfuzur.rahman@icddrb.org
Contact: Zannatun Nyma, MPH +88-01790743741 zannatun.nyma@icddrb.org

Locations
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Bangladesh
Secondary Schools in Rangpur Not yet recruiting
Rangpur, Bangladesh
Contact: Mahfuzur Rahman, MPH    +880-2-9827001-10 ext 2594    mahfuzur.rahman@icddrb.org   
Contact: Zannatun Nyma, MPH    +88-01790743741    zannatun.nyma@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT04116593     History of Changes
Other Study ID Numbers: PR-19089
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Nutrition education
Dietary diversity
Adolescent girls
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders