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临床试验/NCT05311436
NCT05311436招募中不适用

Nutri-CAP: Nutrition for Children, Adolescent Girls, and Pregnant Women in Slums of Dhaka City

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 3,278 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
3,278
试验地点
1
主要终点
Dietary Diversity

研究概览

简要总结

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

详细描述

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 (&amp;amp;gt;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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Day 至 39 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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
  • •Aged 0-24 months
  • •Youngest child of the household
  • •Caregivers have the plan to stay in the study area at least up to two years of age
  • •Not enrolled in any nutrition project/programme currently

排除标准

  • •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
  • •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
  • •Subject involved in any nutrition programme/intervention currently

研究组 & 干预措施

Experimental

Experimental
  1. 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.

干预措施: Experimental - Intensive nutrition counselling for pregnant, adolescent and under2 children (Behavioral)

Control

No Intervention

Participants will receive the standard of care in the area

结局指标

主要结局

Dietary Diversity

时间窗: 6 months

Change in Dietary Diversity of Adolescent Girl

Improve linear growth

时间窗: 1 year

Change in length for age z-score of children less than 2 years

Gestational weight gain

时间窗: From the 16th week of gestation to child birth

Change in gestational weight gain and rate of weight gain in the pregnant woman

Improved maternal WASH practices

时间窗: 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

次要结局

  • Hemoglobin level of adolescent girl(6 months)
  • IYCF indicators(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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