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:
- 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?
- 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:
- Receive counselling from trained Lady Health Workers and healthcare providers on nutrition, hygiene, and heat-adaptation practices.
- Take part in household surveys assessing knowledge, attitudes, and practices.
- Followed over time during pregnancy and early childhood (only applies to a cohort of participants).
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Sajid B Soofi, MBBS, FCPS
- 電話番号:92 21 34930051
- メール:sajid.soofi@aku.edu
研究連絡先のバックアップ
- 名前:Shah Muhammad, MBBS, MPH, PhD
- 電話番号:92 21 34930051
- メール:shah.muhammad@aku.edu
研究場所
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Sindh
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Karachi、Sindh、パキスタン、7480 0
- 募集
- The Aga Khan University
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コンタクト:
- Sajid B Soofi, MBBS, FCPS
- 電話番号:92 21 34930051
- メール:sajid.soofi@aku.edu
-
コンタクト:
- Shah Muhammad, MBBS, MPH, PhD
- 電話番号:92 21 349300
- メール:shah.muhammad@aku.edu
-
主任研究者:
- Sajid B Soofi, MBBS, FCPS
-
副調査官:
- Shah Muhammad, MBBS, MPH, PhD
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし: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).
|
|
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実験的: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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Knowledge, Attitudes, and Practices (KAP)
時間枠:Baseline (pre-intervention) and endline (immediately post-intervention, approximately 30 months after baseline).
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Knowledge, attitudes, and practices (KAP) regarding nutrition, infant and young child feeding (IYCF), IYCF-related hygiene, WASH and heat adaptation measures.
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Baseline (pre-intervention) and endline (immediately post-intervention, approximately 30 months after baseline).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Anthropometric Measures - Mid-Upper Arm Circumference (MUAC)
時間枠: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.
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Measurement of mid-upper arm circumference in centimeters and/or millimeters to assess nutritional status.
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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.
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Anthropometric Measures - Length-For-Age
時間枠: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.
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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.
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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.
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Anthropometric Measures - Weight-For-Age
時間枠: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.
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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.
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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.
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Anthropometric Measure - Weight-For-Length
時間枠: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.
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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.
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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.
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協力者と研究者
捜査官
- 主任研究者:Zulfiqar Bhutta, PhD, MBBS, FRCPCH, FAAP、The Hospital for Sick Children (SickKids), Centre for Global Child Health
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
- 低・中所得国
- パキスタン
- 乳幼児の食事(IYCF)
- クラスターランダム化比較試験
- 母子の栄養
- パキスタンの地方
- 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
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-11794-36417
- 2025 (米国 NIH グラント/契約:Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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