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

11 september 2026 uppdaterad av: 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).

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

5000

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

    • Sindh
      • Karachi, Sindh, Pakistan, 7480 0
        • Rekrytering
        • The Aga Khan University
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Sajid B Soofi, MBBS, FCPS
        • Underutredare:
          • Shah Muhammad, MBBS, MPH, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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).
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Knowledge, Attitudes, and Practices (KAP)
Tidsram: 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).

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Anthropometric Measures - Mid-Upper Arm Circumference (MUAC)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Zulfiqar Bhutta, PhD, MBBS, FRCPCH, FAAP, The Hospital for Sick Children (SickKids), Centre for Global Child Health

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 februari 2026

Primärt slutförande (Beräknad)

1 juni 2028

Avslutad studie (Beräknad)

1 juni 2028

Studieregistreringsdatum

Först inskickad

29 juli 2026

Först inskickad som uppfyllde QC-kriterierna

11 september 2026

Första postat (Faktisk)

15 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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IPD-planbeskrivning

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.

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