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Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan (IGNIT3)

2026年9月11日 更新者:Zulfiqar Bhutta、The Hospital for Sick Children

Cluster-Randomized Controlled Trial to Evaluate the Effectiveness of Climate-Responsive Integrated Nutrition, WASH, and Heat Adaptation Counselling Strategies to Improve Maternal and Child Health and Nutrition Outcomes in Sindh Province, Pakistan - Protocol

The goal of this clinical trial is to evaluate whether a climate-responsive integrated package of nutrition, hygiene (WASH), and heat-adaptation counselling can improve maternal and child health and nutrition outcomes among women of reproductive age and young children in rural Sindh, Pakistan.

The main questions it aims to answer are:

  1. Does training Lady Health Workers, at the community level improve women's knowledge, attitudes, and practices related to maternal nutrition, infant and young child feeding, hygiene, and heat-adaptation behaviours?
  2. Does training healthcare providers at facilities improve women's knowledge, attitudes, and practices related to maternal nutrition, infant and young child feeding, hygiene, and heat-adaptation behaviours?

Researchers will compare communities receiving the enhanced training package to those receiving standard care to determine its effectiveness.

Participants will:

  1. Receive counselling from trained Lady Health Workers and healthcare providers on nutrition, hygiene, and heat-adaptation practices.
  2. Take part in household surveys assessing knowledge, attitudes, and practices.
  3. Followed over time during pregnancy and early childhood (only applies to a cohort of participants).

研究概览

详细说明

Pakistan is a lower-middle-income country that has faced prolonged political and regional instability, all of which have contributed to sub-optimal health and nutrition indicators and service delivery. The country also experiences frequent climate-related disasters, particularly in Sindh and Khyber Pakhtunkhwa (KP), further impacting health outcomes. Primary health care (PHC) has been the cornerstone for delivering essential maternal, child, and community health services in Pakistan, particularly in rural and semi-urban areas where access to tertiary care facilities is limited. Frontline health workers, especially Lady Health Workers (LHWs), along with healthcare providers (HCPs) based at Rural Health Centres (RHCs) and Basic Health Units (BHUs), are central to maternal and child healthcare. Given the recognition of climate variability as a determinant of health and nutritional status, the integration of climate-responsive strategies in health and nutrition programs for LHWs and HCPs is critical. However, evidence on integrated, climate-responsive nutrition strategies within health systems remains scarce. Thus, this study intends to report the effectiveness and value of integrating multi-sectoral content into routine HCP and LHW training packages. The evidence generated will also provide information on the feasibility, acceptability, and scalability of an integrated climate-responsive training package.

This study will be a two-arm, prospective, cluster-randomized controlled trial to evaluate the effectiveness of the Enhanced Climate-Responsive Integrated Nutrition Training Package in Matiari and Sanghar districts, Sindh province, Pakistan. Matiari is situated in the northeastern part of Sindh, while Sanghar lies adjacent to Matiari and represents a larger rural district with similar socio-demographic and health system characteristics. The study setting has a well-established community and health system liaison, basic demographic surveillance, and field centres for research. These sites have also been selected because they have been the locations of several other large cluster-randomized trials, meaning that households are well mapped using household-level GIS. This district is representative of typical conditions in Pakistan, and there is a close working relationship with the community, civic society leaders, and public health department facilities.

For the baseline and endline surveys, the target population is all households with at least one pregnant or lactating woman (PLW) or a woman of reproductive age (WRA) with a child under the age of six months. Additionally, a select cohort of pregnant women will be enrolled and followed up quarterly through the trial duration. The training will be provided to all HCPs and LHWs in the intervention areas of the target districts. HCPs will include doctors, nurses, midwives, and lady health visitors, while lady health supervisors (LHSs) will be trained as master trainers for LHWs.

The training package for primary HCPs will be administered directly by trained project staff at the intervention sites. HCPs will include medical officers, nurses, Lady Health Visitors (LHVs), and midwives working at PHC facilities, including BHUs, RHCs, and Dispensaries. The enhanced integrated package for HCPs offers updated guidance on IYCF, maternal and adolescent nutrition, and specialized pediatric nutrition with a gender and climate lens. Rapid refresher training will be conducted every six months. LHSs, who are master trainers for LHWs, will be trained by senior faculty members of the AKU. These master trainers will subsequently train LHWs from the intervention clusters at their affiliated health facilities. This initial two-day training would be followed by monthly rapid refresher training sessions at the LHWs' regular continuing education sessions. In addition, there will be biannual one-day comprehensive refresher training sessions and assessments for both LHSs and LHWs.

If effective, the enhanced integrated training package could be sustainably incorporated within the pre-service and in-service health workforce curricula in climate-vulnerable LMICs, where resources are limited, and interactions between health workers and communities provide valuable opportunities to promote appropriate adaptive and resilient health and nutrition behaviours.

A limitation of the trial is that it does not provide material or financial support to participants, which may limit its ability to address nutrition challenges exacerbated by poverty, food insecurity, and limited resources. In addition, the two-year intervention period may be insufficient to detect measurable impact of certain outcomes, particularly birth and anthropometric indicators. Community representatives from Matiari and Sanghar were engaged during the development of the trial design, and study findings will be shared with the communities through dissemination and engagement events, at the conclusion of the project.

研究类型

介入性

注册 (估计的)

5000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Sajid B Soofi, MBBS, FCPS
  • 电话号码:92 21 34930051
  • 邮箱:sajid.soofi@aku.edu

研究联系人备份

学习地点

    • Sindh
      • Karachi、Sindh、巴基斯坦、7480 0
        • 招聘中
        • The Aga Khan University
        • 接触:
        • 接触:
        • 首席研究员:
          • Sajid B Soofi, MBBS, FCPS
        • 副研究员:
          • Shah Muhammad, MBBS, MPH, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Household has at least one pregnant or lactating woman (PLW) OR woman of reproductive age (WRA) with a child less than 24 months old
  • Resident of the selected clusters of the district
  • Permanent resident of the household
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Household does not include a pregnant or lactating woman (PLW) OR a woman of reproductive age (WRA) with a child less than 24 months
  • Household does not provide informed consent
  • Woman is a known case of chronic hypertension
  • Woman is a known case of pre-eclampsia
  • Woman is a known case of type 1 diabetes
  • Woman is a known case of type 2 diabetes
  • Woman is a known case of gestational diabetes
  • Woman is a known case of hypothyroidism or hyperthyroidism
  • Woman is a known case of tuberculosis
  • Child has congenital anomalies or medical conditions

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control Arm
Control clusters will continue to receive standard of care from their respective LHWs. Training and refresher training of LHWs will be provided as per routine using the existing curriculum. Both arms will have equal access to the Benazir Income Support Programme (BISP) and the Benazir Nashonuma Programme (BNP).
实验性的:Intervention Arm
The intervention clusters will be covered by healthcare providers and LHWs who have received cascade training on enhanced nutritional counselling, IYCF-related hygiene, and heat adaptation strategies. Both arms will have equal access to the Benazir Income Support Programme (BISP) and the Benazir Nashonuma Programme (BNP).
Lady Health Workers receive training aimed at improving their ability to deliver information and counselling to women on maternal nutrition, infant and young child feeding, hygiene, and heat-adaptation behaviours.
Healthcare providers at health facilities receive training to strengthen their delivery of information and counselling to women on maternal nutrition, infant and young child feeding, hygiene, and heat-adaptation behaviours.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Knowledge, Attitudes, and Practices (KAP)
大体时间:Baseline (pre-intervention) and endline (immediately post-intervention, approximately 30 months after baseline).
Knowledge, attitudes, and practices (KAP) regarding nutrition, infant and young child feeding (IYCF), IYCF-related hygiene, WASH and heat adaptation measures.
Baseline (pre-intervention) and endline (immediately post-intervention, approximately 30 months after baseline).

次要结果测量

结果测量
措施说明
大体时间
Anthropometric Measures - Mid-Upper Arm Circumference (MUAC)
大体时间:Baseline (pre-exposure to information and counselling) and follow-up assessment after exposure to information and counselling delivered by trained Lady Health Workers or healthcare providers.
Measurement of mid-upper arm circumference in centimeters and/or millimeters to assess nutritional status.
Baseline (pre-exposure to information and counselling) and follow-up assessment after exposure to information and counselling delivered by trained Lady Health Workers or healthcare providers.
Anthropometric Measures - Length-For-Age
大体时间:Baseline (pre-exposure to information and counselling) and follow-up assessment after exposure to information and counselling delivered by trained Lady Health Workers or healthcare providers.
Length-for-age is an indicator of a child's linear growth and will be measured relative to the child's age and sex. It will be used to assess growth and the prevalence of stunting among children under 24 months.
Baseline (pre-exposure to information and counselling) and follow-up assessment after exposure to information and counselling delivered by trained Lady Health Workers or healthcare providers.
Anthropometric Measures - Weight-For-Age
大体时间:Baseline (pre-exposure to information and counselling) and follow-up assessment after exposure to information and counselling delivered by trained Lady Health Workers or healthcare providers.
Weight-for-age is an indicator of a child's body weight and will be measured relative to the child's age and sex. It will be used to assess overall growth status and the prevalence of underweight among children under 24 months.
Baseline (pre-exposure to information and counselling) and follow-up assessment after exposure to information and counselling delivered by trained Lady Health Workers or healthcare providers.
Anthropometric Measure - Weight-For-Length
大体时间:Baseline (pre-exposure to information and counselling) and follow-up assessment after exposure to information and counselling delivered by trained Lady Health Workers or healthcare providers.
Weight-for-length is an indicator of a child's weight relative to their length. It will be used to assess acute undernutrition and the prevalence of wasting among children under 24 months.
Baseline (pre-exposure to information and counselling) and follow-up assessment after exposure to information and counselling delivered by trained Lady Health Workers or healthcare providers.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Zulfiqar Bhutta, PhD, MBBS, FRCPCH, FAAP、The Hospital for Sick Children (SickKids), Centre for Global Child Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月19日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年7月29日

首先提交符合 QC 标准的

2026年9月11日

首次发布 (实际的)

2026年9月15日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

IPD will not be shared due to confidentiality concerns related to sensitive maternal and child health information collected at the household level, and restrictions outlined in ethical approvals.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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