Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05311436
Status:
UNKNOWN
Last Update Posted:
2022-08-30
First Post:
2022-03-27
Brief Title:
Nutri-CAP Nutrition for Children Adolescent Girls and Pregnant Women in Slums of Dhaka City
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
Official Title:
Nutri-CAP Nutrition for Children Adolescent Girls and Pregnant Women in Slums of Dhaka City
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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 150000 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 kgweek 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
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 150000 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 kgweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None