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

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).

Study Overview

• Status: Recruiting
• Conditions: Maternal Nutrition; Child Nutrition
• Intervention / Treatment: Behavioral: Training of Lady Health Workers (LHWs); Behavioral: Training of Healthcare Providers (HCPs) at Facilities

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sajid B Soofi, MBBS, FCPS; Phone Number: 92 21 34930051; Email: sajid.soofi@aku.edu
• Study Contact Backup: Name: Shah Muhammad, MBBS, MPH, PhD; Phone Number: 92 21 34930051; Email: shah.muhammad@aku.edu

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 7480 0
      • Recruiting
      • The Aga Khan University
      • Contact: Sajid B Soofi, MBBS, FCPS; Phone Number: 92 21 34930051; Email: sajid.soofi@aku.edu
      • Contact: Shah Muhammad, MBBS, MPH, PhD; Phone Number: 92 21 349300; Email: shah.muhammad@aku.edu
      • Principal Investigator: Sajid B Soofi, MBBS, FCPS
      • Sub-Investigator: Shah Muhammad, MBBS, MPH, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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).
Experimental: 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).	Behavioral: Training of Lady Health Workers (LHWs); 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.; Behavioral: Training of Healthcare Providers (HCPs) at Facilities; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge, Attitudes, and Practices (KAP)	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric Measures - Mid-Upper Arm Circumference (MUAC)	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	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	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	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.

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Aga Khan University
• Investigators: Principal Investigator: Zulfiqar Bhutta, PhD, MBBS, FRCPCH, FAAP, The Hospital for Sick Children (SickKids), Centre for Global Child Health

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: September 11, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Low- and middle-income countries; Pakistan; Infant and young child feeding (IYCF); Cluster randomized controlled trial; Maternal and child nutrition; Rural Pakistan; WASH (water, sanitation, and hygiene); Climate-responsive interventions; Heat adaptation; Climate change and health; Frontline health worker training; Lady Health Workers (LHWs); Primary healthcare workers; Behaviour change counselling; Knowledge, attitudes, and practices (KAP); Sindh; Low- and middle-income settings
• Additional Relevant MeSH Terms: Behavior
• Other Study ID Numbers: 2025-11794-36417; 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No