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Maternal NutritionIGNIT3NCT07819994

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

A study testing Training of Lady Health Workers (LHWs) and Training of Healthcare Providers (HCPs) at Facilities in people with Maternal Nutrition and Child Nutrition, run by The Hospital for Sick Children at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Maternal Nutrition, Child Nutrition
What is being tested?
Training of Lady Health Workers (LHWs) and Training of Healthcare Providers (HCPs) at Facilities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,000 participants
Where
1 sitePakistan
Study dates
19 Feb 2026to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sajid B Soofi, MBBS, FCPS contact

92 21 34930051

sajid.soofi@aku.edu

Shah Muhammad, MBBS, MPH, PhD contact

92 21 34930051

shah.muhammad@aku.edu

Pakistan1 site, 1 recruiting
  • The Aga Khan University

    Karachi, Sindh, 7480 0

    Sajid B Soofi, MBBS, FCPS, 92 21 34930051, sajid.soofi@aku.edu

    Shah Muhammad, MBBS, MPH, PhD, 92 21 349300, shah.muhammad@aku.edu

    Recruiting

Other trials in Pakistan

About this study

Official title: 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 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:

Read more
  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.

Being tested
Training of Lady Health Workers (LHWs), Training of Healthcare Providers (HCPs) at Facilities
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
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training of Lady Health Workers (LHWs)Behavioural

    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.

  • Training of Healthcare Providers (HCPs) at FacilitiesBehavioural

    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.

Study groups in NCT07819994
Study groupRoleWhat they receive
Control ArmNo interventionControl 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.
Intervention ArmExperimentalThe 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.
Receives: Behavioral: Training of Lady Health Workers (LHWs); Behavioral: Training of Healthcare Providers (HCPs) at Facilities

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)
  1. Anthropometric Measures - Mid-Upper Arm Circumference (MUAC)

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: Assessed at delivery (birth)

  6. Birth outcome - Low birth weight

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

    Measured: Assessed at delivery (birth)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2026
  2. Study start19 Feb 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to two different intervention arms (LHW training + HCP training vs. control), and all groups are followed simultaneously, with outcomes compared between them at the end. There will also be a prospective longitudinal cohort nested within the trial of pregnant women \<18 weeks.
Masking
None (open label)
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07819994
Sponsor's protocol ID
2025-11794-36417
Other IDs
2025
Acronym
IGNIT3
Status last verified
Oct 2026
First submitted
29 Jul 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Training of Lady Health Workers (LHWs) and Training of Healthcare Providers (HCPs) at Facilities in people with Maternal Nutrition and Child Nutrition, run by The Hospital for Sick Children at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sajid B Soofi, MBBS, FCPS (92 21 34930051, sajid.soofi@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge, Attitudes, and Practices (KAP) (time frame: Baseline (pre-intervention) and endline (immediately post-intervention, approximately 30 months after baseline).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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