International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)
Dhaka, Dhaka Division, 1212, Bangladesh
Location status: Recruiting
NCT Number: NCT05311436
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
Interested in participating?
Request Info1 day–39 year
All sexes
Interventional
Not applicable
Dhaka, Dhaka Division, 1212, Bangladesh
Location status: Recruiting
Background
Methods
This study will be conducted in the Bauniabadh and the adjacent slum areas of Dhaka city. This study includes a community survey, formative study, community-based nutrition intervention, and an evaluation of the programmatic intervention using a quasi-experimental design.
Bauniabadh slum area has a population of ~150,000. It has five blocks: A, B, C, D, and E. Blocks B, C, and E will be the intervention area for programmatic intervention and A and D will be the control area where no intervention will be provided. Blocks A, and D is separated from other blocks by a road, a school, and a water body.
At first, a community survey will be conducted to identify the total number of beneficiaries in both the control and intervention areas: under 2 years old children, adolescent girls, and pregnant women at or before 16 weeks of gestation.
The formative research includes 24-h dietary recalls, in-depth interviews with purposively selected household heads, women, adolescent girls, and focus group discussions with women and adolescent girls to explore the locally available foods to prepare nutritious diets for pregnant women and adolescent girls. Moreover, this formative study will help in tailoring the messages for group counseling sessions on nutrition and WASH on the perspectives of the slum dwellers in Dhaka city. All counseling materials for the programmatic intervention will be developed from data generated from the formative research and using existing materials.
In the intervention area, nutrition intervention will be provided to all pregnant women, adolescent girls, and children under the age of 2 years. For pregnant women, intensive dietary counseling will be provided through household visits. The intervention also includes daily iron-folate and calcium supplementation to the pregnant women for the remaining pregnancy period till childbirth, and at least four antenatal visits to local ANC service providers will be ensured. For all adolescent girls, monthly two nutrition education sessions for six months will be organized to improve dietary diversity. Adolescent girls will also receive weekly iron and folate supplementation for 3 months and 10 mg of zinc sulfate tablet daily for 1 month. Training research staff will do monthly growth monitoring and promotion for all under 2-year-old children. All children suffering from acute malnutrition will be treated and severely stunted children will be supplemented with one egg daily for 3 consecutive months and multiple micronutrient powders for 2 months. Additionally, counseling on water sanitation and hygiene, and food safety will be provided to the mother of the child participants. This program will also ensure community participation to improve the garbage disposal system, water supply and cleaning of drains in the area.
The primary outcome measures will be total pregnancy weight gain (kg) and rate of weight gain (kg/week) for pregnant women. Change in dietary diversity scores in adolescent girls, change in maternal WASH practices, and change in length-for-age z-score for children under the age of 2 years.
Evaluation will be done using a quasi-experimental design. Data related to outcome indicators will be collected from target groups from both the intervention and the controls areas.
At the end of the intervention, based on calculated sample sizes to see the changes in outcome variables, at a 5% level of significance with 90% power, we will need to enroll at least 199 pregnant women, 572 adolescent girls, 420 children below 2years, 89 children below 2years (WASH group) in each group. Based on previous data, we assume that the total available sample sizes for the programmatic intervention will be 400 pregnant women, 1200 adolescent girls, 1500 for children below 2years, and 178 children below 2years for WASH group. Therefore, our sample size will have more than enough power to test our hypotheses.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adolescent girls:
Children:
Exclusion criteria
Adolescent girls:
Children:
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.
Other names: Iron, folic acid and calcium supplementation for pregnant women, Zinc and iron-folate supplementation to adolescent gilrs, Egg supplementation to severely stunted children daily for 3 months to
Time frame: From the 16th week of gestation to child birth
Change in gestational weight gain and rate of weight gain in the pregnant woman
Time frame: 6 months
Change in Dietary Diversity of Adolescent Girl
Time frame: 1 year
Change in length for age z-score of children less than 2 years
Time frame: 6 months
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
Time frame: 6 months
A change in hemoglobin level Adolescent Girl
Time frame: 1 year
A change in WHO's core IYCF indicators for Children <2 years
Time frame: 16 week of pregnancy to child birth
A change in hemoglobin level of Pregnant woman
Contact information is provided by the study sponsor or research team.
Fahmida Farzana, MSc, MPH
CONTACT
_+880-2-2222277001-10 ext. 2280
Mustafa Mahfuz, MBBS, MPH, PhD
CONTACT
_+880-2-2222277001-10 ext. 2304
International Centre for Diarrhoeal Disease Research, Bangladesh
Other
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