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RecruitingNCT07819994IGNIT3Updated Oct 29, 2026

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

An interventional study of Training of Lady Health Workers (LHWs) and Training of Healthcare Providers (HCPs) at Facilities in Maternal Nutrition and Child Nutrition, sponsored by The Hospital for Sick Children. Recruiting at 1 site in Pakistan. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Feb 2026, registered Jul 2026).
  • Started Feb 2026; still recruiting 8 months later.
Updated Oct 7, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Randomized
Ages
15 Years to 49 Years
Sex
Female
01

Study summary

The goal of this trial is to evaluate whether a climate- and gender-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).
Read the 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.

02

Conditions studied

  • Maternal Nutrition
  • Child Nutrition

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Keywords

  • Maternal and child nutrition
  • Infant and young child feeding (IYCF)
  • 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)
  • Cluster randomized controlled trial
  • Pakistan
  • Rural Pakistan
  • Sindh
  • Low- and middle-income settings
  • Low- and middle-income countries
03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 120 across 1,197 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 7, 2026. See what changed

Ages eligible
15 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Cohort: All pregnant women identified at baseline who are \<18 weeks' gestation will be invited to enroll in the prospective longitudinal cohort nested within the trial. Only women who provide informed consent and agree to longitudinal follow-up at four-month intervals throughout pregnancy and until their child reaches 12-18 months of age will be enrolled

Exclusion criteria

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,000 participants (estimated)

Study arms

  • 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.

  • Experimental
    Intervention Arm

    The intervention clusters will be covered by healthcare providers and LHWs who have received cascade training on enhanced climate- and gender-responsive nutritional counselling, IYCF-related hygiene, and heat adaptation strategies.

    Behavioral: Training of Lady Health Workers (LHWs) · Behavioral: Training of Healthcare Providers (HCPs) at Facilities

Interventions

  • BehavioralTraining of Lady Health Workers (LHWs)

    Lady Health Workers receive training aimed at improving their ability to deliver climate- and gender-responsive information and counselling to women on maternal nutrition, infant and young child feeding, hygiene, and heat-adaptation behaviours.

  • BehavioralTraining of Healthcare Providers (HCPs) at Facilities

    Healthcare providers at health facilities receive training to strengthen their delivery of climate- and gender-responsive information and counselling to women on maternal nutrition, infant and young child feeding, hygiene, and heat-adaptation behaviours.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (pre-intervention) and endline (immediately post-intervention, approximately 30 months after baseline).

Secondary outcomes

  1. Anthropometric Measures - Mid-Upper Arm Circumference (MUAC)

    Measurement of mid-upper arm circumference in centimeters and/or millimeters to assess nutritional status.

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. 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.

    Time frame: 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.

  5. Birth outcome - Preterm

    Infants delivered alive before the completion of 37 weeks of gestation

    Time frame: Assessed at delivery (birth)

  6. Birth outcome - Low birth weight

    Infants weighing less than 2500 grams (5.5 pounds) at birth

    Time frame: Assessed at delivery (birth)

07

Study locations

1 of 1 sites recruiting
  • The Aga Khan University
    Karachi, Sindh 7480 0, Pakistan
    Recruiting
    • Sajid B Soofi, MBBS, FCPS · Contactsajid.soofi@aku.edu · 92 21 34930051
    • Shah Muhammad, MBBS, MPH, PhD · Contactshah.muhammad@aku.edu · 92 21 349300
    • Sajid B Soofi, MBBS, FCPS · Principal investigator
    • Shah Muhammad, MBBS, MPH, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Primary completion
Jun 2028→Jul 2028
Oct 7, 2026
Study completion
Jun 2028→Jul 2028
Oct 7, 2026
Eligibility
1 inclusion criterion added
What changed in the criteria
Inclusion criteria
  • AddedCohort: All pregnant women identified at baseline who are <18 weeks' gestation will be invited to enroll in the prospective longitudinal cohort nested within the trial. Only women who provide informed consent and agree to longitudinal follow-up at four-month intervals throughout pregnancy and until their child reaches 12-18 months of age will be enrolled
Oct 7, 2026
Secondary outcomes
2 added
What changed in the outcomes
  • AddedBirth outcome - PretermTime frame: Assessed at delivery (birth)
  • AddedBirth outcome - Low birth weightTime frame: Assessed at delivery (birth)
Oct 29, 2026
Sponsor
Collaborators added: Global Affairs Canada
Oct 7, 2026
Show all 2 updates
  1. Oct 29, 2026
    Secondary outcomes 2 added
    What changed in the outcomes
    • AddedBirth outcome - PretermTime frame: Assessed at delivery (birth)
    • AddedBirth outcome - Low birth weightTime frame: Assessed at delivery (birth)
    + 2 other changes: verification date and description
  2. Oct 7, 2026
    Primary completion Jun 2028→Jul 2028
    Study completion Jun 2028→Jul 2028
    Eligibility 1 inclusion criterion added
    What changed in the criteria
    Inclusion criteria
    • AddedCohort: All pregnant women identified at baseline who are <18 weeks' gestation will be invited to enroll in the prospective longitudinal cohort nested within the trial. Only women who provide informed consent and agree to longitudinal follow-up at four-month intervals throughout pregnancy and until their child reaches 12-18 months of age will be enrolled
    Sponsor Collaborators added: Global Affairs Canada
    + 3 other changes: description, design details and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07819994
Collaborators
Aga Khan University, Global Affairs Canada
Responsible party
Zulfiqar Bhutta (Senior Scientist, SickKids Research Institute; Co-Director, SickKids Centre for Global Child; Professor, University of Toronto, The Hospital for Sick Children) — Principal investigator
First posted
Sep 15, 2026
Start date
Feb 19, 2026
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Oct 29, 2026

Study contacts

Sajid B Soofi, MBBS, FCPS
Contact
sajid.soofi@aku.edu
92 21 34930051
Shah Muhammad, MBBS, MPH, PhD
Contact
shah.muhammad@aku.edu
92 21 34930051
Zulfiqar Bhutta, PhD, MBBS, FRCPCH, FAAP
principal investigator · The Hospital for Sick Children (SickKids), Centre for Global Child Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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