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

NCT07819994 | Recruiting

• 2 other identifiers: 2025-11794-364172025
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Maternal Nutrition; Child Nutrition

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

Outcome Measures

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.

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

Secondary Outcomes (4)

• Anthropometric Measures - Mid-Upper Arm Circumference (MUAC)

  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

  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

  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

  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.

Study Arms (2)

Control Arm

NO INTERVENTION

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).

Intervention Arm

EXPERIMENTAL

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); Behavioral: Training of Healthcare Providers (HCPs) at Facilities

Interventions

Training of Lady Health Workers (LHWs) BEHAVIORAL

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.

Intervention Arm

Training of Healthcare Providers (HCPs) at Facilities BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Aga Khan University: collaborator

Study Sites (1)

The Aga Khan University

Karachi, Sindh, 7480 0, Pakistan

RECRUITING

MeSH Terms

Conditions

Behavior

Study Officials

• Zulfiqar Bhutta, PhD, MBBS, FRCPCH, FAAP

  The Hospital for Sick Children (SickKids), Centre for Global Child Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, SickKids Research Institute; Co-Director, SickKids Centre for Global Child; Professor, University of Toronto

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: September 15, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)