Nutri-CAP: Nutrition for Children, Adolescent Girls, and Pregnant Women in Slums of Dhaka City
1 other identifier
interventional
3,278
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Typical duration for not_applicable
1 active site
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
March 27, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 30, 2024
October 1, 2024
2.8 years
March 27, 2022
October 27, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Gestational weight gain
Change in gestational weight gain and rate of weight gain in the pregnant woman
From the 16th week of gestation to child birth
Dietary Diversity
Change in Dietary Diversity of Adolescent Girl
6 months
Improve linear growth
Change in length for age z-score of children less than 2 years
1 year
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
6 months
Secondary Outcomes (2)
Hemoglobin level of adolescent girl
6 months
IYCF indicators
1 year
Other Outcomes (1)
Hemoglobin level of Pregnant woman
16 week of pregnancy to child birth
Study Arms (2)
Experimental
EXPERIMENTAL1. Pregnant women will receive monthly intensive dietary counseling, daily iron-folate, calcium supplementation, and at least four antenatal visits to local ANC service providers from enrollment before 16 weeks of gestation to delivery of the baby will be ensured. 2. Adolescent girls will receive twice-monthly nutrition education sessions to improve dietary diversity scores from enrolment to 6 months of enrollment. 3. Under 2y children will receive monthly growth monitoring and promotion, IYCF counseling 4. Under 2y children for WASH counseling group will receive twice-monthly nutrition education sessions for 6months to improve maternal WASH practices 5. Severely stunted children: Daily 1 egg for 3 consecutive months and 1 sachet of multiple micronutrient powder supplementation for 2 months.
Control
NO INTERVENTIONParticipants will receive the standard of care in the area
Interventions
Pregnant 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.
Eligibility Criteria
You may qualify if:
- Pregnant women:
- 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
- Willing to participate in the study
- Not enrolled in any nutrition project/programme currently
- Adolescent girls:
- Aged 11-19 years
- Willing to participate in the study
- Not involved in any nutrition project/programme
- Will stay in the study area for the next 2 years
- Children:
- Aged 0-24 months
- Youngest child of the household
- +2 more criteria
You may not qualify if:
- Pregnant women:
- 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)
- Extremely obese
- Subject involved in any nutrition programme/ intervention currently
- Adolescent girls:
- Subject not willing to give assent/consent
- Subject has the plan to migrate outside the study area during the study period
- Subject involved in any nutrition programme/intervention currently
- Children:
- Caregiver/guardian not willing to provide consent
- Have the plan to migrate outside of the study area during the study period
- Child with any congenital anomaly
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)
Dhaka, Dhaka Division, 1212, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mustafa Mahfuz, MBBS, MPH, PhD
International Centre for Diarrhoeal Disease Research, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2022
First Posted
April 5, 2022
Study Start
April 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 30, 2024
Record last verified: 2024-10