Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05311436 |
| Other study ID # |
PR-21082 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
August 31, 2024 |
Study information
| Verified date |
April 2022 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
Mustafa Mahfuz, MBBS, MPH |
| Phone |
_+880-2-2222277001-10 |
| Email |
mustafa[@]icddrb.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
Background
1. Burden: The emergence of COVID-19 poses a substantial public health risk to the world.
Our research done at the peak of the lockdown in Dhaka city showed that 90% of more than
200 households surveyed in a slum in Dhaka city and villages of Matlab in rural
Bangladesh suffered from food insecurity, the situation was worse in the slum areas. Our
previous work demonstrated that 50% of under-five children in slums have stunted growth,
half of all children suffer from deficiency of zinc. Our recently completed study
revealed that third-trimester weight gain was poor in general among rural women in
Matlab, Bangladesh, and 54% of the women failed to gain adequate weight (>4 kg) in the
third trimester.
2. Knowledge gap: Although the burden of undernutrition, as well as adverse consequences of
nutritional impairment, is prominent in Bangladesh, there is no platform to implement
sustainable nutrition delivery services in slums, particularly for children, adolescent
girls, and mothers with pregnancy. In addition, there lack of data on the status of
pregnancy weight gain, dietary diversity both in pregnant women and adolescent girls in
slums. Evidence on the role of Infant and Young Child Feeding (IYCF), growth monitoring
and promotion, micronutrient supplementation, and counseling on Water, Sanitation, and
Hygiene (WASH) in improving childhood growth and ameliorating Environmental Enteric
Dysfunction (EED) is also limited.
3. Relevance: Such lack of knowledge limits the success of nutritional programs being done
in slums. Moreover, it is causing obstacles in reducing the nutritional burden among
three vulnerable groups of the population.
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 six months. Additionally,
counseling on water sanitation and hygiene, and food safety will be provided to all
beneficiary households. This program will 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 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 <2 children 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, and 1500 for children <2
years. Therefore, our sample size will have more than enough power to test our hypotheses.
