About this trial
The objective of the research project is to establish an evidence-based sustainable nutrition service delivery platform for optimizing pregnancy weight gain, increasing dietary diversity of adolescent girls, and ensuring proper physical growth of under 2 children.
Hypothesis
1. Pregnant Women: Intensive nutrition and WASH counseling, iron-folate, calcium supplementation during pregnancy, can improve gestational weight gain and improve hemoglobin status in pregnant women in a slum of Dhaka city 2. Adolescent girl: Iron and zinc supplementation and nutrition counseling on dietary diversity could improve nutritional status and dietary diversity score in adolescent girls of slums in Dhaka 3. Children \<2 years: Counselling on IYCF, growth monitoring, and promotion, ensuring six-monthly vitamin A supplementation, counseling on WASH, treatment of acute malnutrition, and daily 1 egg supplementation for 3 months for severely stunted children can improve the nutritional status of children 4. Counselling to improve Water, Sanitation and Hygiene (WASH) practice: WASH intervention can improve EED biomarkers
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-39 years
Before 16 weeks of gestation
BMI 15-24.99 kg/m2 measured on enrolment
Have the plan to stay in the study area till delivery
Disqualifiers
Subject not willing to provide consent
Subject has the plan to migrate outside of the study area during the study period
Subject has a plan to go elsewhere ( village/ parents' house) for delivery
Any reported/diagnosed chronic diseases (such as hypertension, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, pancreatic diseases, diabetes mellitus, thyroid dysfunction, immunological diseases, malignancy, or any other diseases which could impede compliance with the study protocol)
Trial design
Parallel
Treatments tested in this trial
Experimental - Intensive nutrition counselling for pregnant, adolescent and under2 children
BehavioralPregnant women: Intensive dietary counseling using diet chart for locally available food, and to attend antenatal care services from local ANC providers, daily Iron, folic acid, and calcium supplementation. Adolescent girls: Group sessions in the nutrition centers with the adolescent girls will be conducted twice monthly for 6 months. Iron and folic acid (200 mg ferrous fumarate and 400 μg folic acid); once weekly for 3 months; zinc 10 mg daily for 1 month. Children \<2 years: Behavioral counseling sessions through monthly home visits on Infant and Young Child feeding, Growth monitoring and promotion, and water sanitation and hygiene, and food safety. Intensive WASH counselling: Intensive WASH counseling will be provided to separate group of child participants twice a month for 6 months. Severely stunted children: 1 egg supplementation for 3 months and 1 sachet of multiple micronutrient powder (1 RDA of vitamin A and C, iron-folic acid, and zinc) daily for 2 months.
Treatment groups
Trial outcomes
Primary outcomes
Gestational weight gain
Change in gestational weight gain and rate of weight gain in the pregnant woman
Dietary Diversity
Change in Dietary Diversity of Adolescent Girl
Improve linear growth
Change in length for age z-score of children less than 2 years
Improved maternal WASH practices
Improvement in maternal WASH practics will be assessed through use of safe water, handwashing practice during critical times, use of hygienic/ improved toilet using a structured questionnaire
Secondary outcomes
Hemoglobin level of adolescent girl
A change in hemoglobin level Adolescent Girl
IYCF indicators
A change in WHO's core IYCF indicators for Children \<2 years
Other outcomes
Hemoglobin level of Pregnant woman
A change in hemoglobin level of Pregnant woman
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
International Centre for Diarrhoeal Disease Research, Bangladesh
Lead sponsor
Global Affairs Canada
Collaborator