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CTRI Number  CTRI/2023/10/058538 [Registered on: 11/10/2023] Trial Registered Prospectively
Last Modified On: 06/05/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Scaling up women and child interventions in Himachal Pradesh 
Scientific Title of Study
Modification(s)  
Pilot Scale up Programme of WINGS interventions in Five Blocks of District Una (Amb, Dhundla/Thanakalan, Gagret, Haroli, and Una/Basdhera) of Himachal Pradesh 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarmila Mazumder 
Designation  Senior Deputy Director and Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi

South
DELHI
110016
India 
Phone  46043751  
Fax  46043756  
Email  sarmila.mazumder@sas.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sarmila Mazumder 
Designation  Senior Deputy Director and Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi

South
DELHI
110016
India 
Phone  46043751  
Fax  46043756  
Email  sarmila.mazumder@sas.org.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sarmila Mazumder 
Designation  Senior Deputy Director and Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi

South
DELHI
110016
India 
Phone  46043751  
Fax  46043756  
Email  sarmila.mazumder@sas.org.in  
 
Source of Monetary or Material Support  
The project will be funded by the Bill & Melinda Gates Foundation (BMGF) routed through the Department of Biotechnology, BIRAC Grand Challenges-platform. 
 
Primary Sponsor  
Name  Centre for Health Research and Development Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi 
Type of Sponsor  Other [Not for profit research organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarmila Mazumder  District Hospital, Una, Himachal Pradesh  District Hospital, Una, Himachal Pradesh Department of Women and Child Health, Himachal Pradesh Una
Una
HIMACHAL PRADESH 
46043751
46043756
sarmila.mazumder@sas.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Review Committee, Society for Applied Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health and ICDS providers and beneficiaries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not Applicable  Not Applicable 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Preconception women in reproductive age group with no or one child, pregnant women, children less than 2 years of age and their family members.  
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1.Health systems strengthening and streamlining of processes, by identifying existing gaps and implementing solutions for improved health of mothers and infants through Innovative and Sustainable approaches.

2.Enhanced commitment and resources for improving health of mothers and infants through evidence-informed advocacy. 
Throughout the period of 3 years 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To estimate the incremental cost of implementing WINGS interventions within the government health systems  At the time of endline survey 
 
Target Sample Size
Modification(s)  
Total Sample Size="3600"
Sample Size from India="3600" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
Jadaun AS, Kumar J, Gadapani Pathak B, Devi S, Thakur PK, Beri G, Dutt M, Thakur S, Verma SK, Mankotia S, Chauhan A, Kumar R, Chaudhary A, Kalia R, Sharma D, Chowdhury R, Dhabhai N, Anand VK, Taneja S, Bhandari N, Mazumder S. Implementation research to scale up the women and infants integrated interventions for growth study (WINGS) in Himachal Pradesh: Protocol for a quasi-experimental, mixed-methods study. PLoS One. 2026 Feb 17;21(2):e0341048. doi: 10.1371/journal.pone.0341048. PMID: 41701715; PMCID: PMC12912596. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The Society for Applied Studies (CHRD SAS) recently conducted an individual randomized controlled trial (WINGS – The Women and Infants Integrated Interventions for Growth Study) which showed that an aimed to measure the impact of an integrated package of interventions (health, nutrition, psychosocial care and support and water, sanitation, and hygiene (WaSH), delivered during preconception, pregnancy and early childhood substantially reduced low birth weight and stunting at 24 months. Pregnancy and early childhood interventions alone had lower but important effects on birth outcomes and 24 month outcomes. Preconception interventions alone had an important effect on birth outcomes but not on 24 month outcomes.

Low birth weight (LBW) and stunting (length-for-age z score<�’2 standard deviations) continue to be important impediments for children to survive and thrive, and for achievement of sustainable development goals. LBW is a complex syndrome that includes preterm birth and small-for-gestational age (SGA) babies and an overlap of both.

LBW infants have an increased risk of morbidity, developmental and behaviour problems during childhood, and cardiometabolic disease in adulthood. Stunting is a global problem, more so in India where the prevalence in children younger than 5 years is 37.9%. The annual reduction rate for LBW in South Asia is about half, and that for stunting about three quarters of that required to meet the 2025 global nutrition targets.

Research addressing LBW and stunting reduction has primarily focused on nutrition interventions.

These studies found modest effects.

Evaluation of interventions covering multiple domains such as health, nutrition, psychosocial care, and the environment is needed to determine if there is a large, synergistic effect when these are delivered together as a package.

Studies indicate that health, nutritional, and psychosocial status before conception could be linked to LBW and stunting. Interventions starting before pregnancy would cover early pregnancy, which is important because pregnancies are reported late in regions like south Asia.

Sample size: A sample size of 600 women and children will be adequate to measure the different levels of outcomes. If not feasible, a minimum of 400 women and children would be needed. We will aggregate data on the key outcomes of interest at block level and use the data collected in 5 blocks in the study district collected at 3 time points pre-intervention and 3 time points post intervention to assess the change in level of outcomes.

Overview of the implementation plan:

Una district, suggested by the HP government and selected based on the consensus of the NITI Aayog, is an average performing district having 5 blocks. One of the blocks will be selected as the learning block or the first block where the implementation model will be optimized.

Formative research will be conducted to identify the barriers, implementation challenges and facilitators of implementing the WINGS integrated interventions in the district. An initial desk review will be done to review and compile the available information with the government pertaining to population, infrastructure, resources including human resources, services, supplies, processes, health management information system, etc. A situation analysis following the initial review will identify the areas that will need to be explored further through formative research. Mixed methods (qualitative and quantitative) will be used. Rapid assessments will be done at the facility and community levels. The formative research findings will feed into the initial implementation model. The interventions will be aligned with the existing government programs that are already being implemented in the state. Some of the WINGS interventions that are not in the government programs, particularly those in the preconception period, a few pregnancy and childhood interventions such as multiple micronutrients, provision of snacks, milk/eggs for low BMI and inadequate weight gain, psychosocial support, etc., will be discussed with the government to devise appropriate strategies.

We will use the non-linear, recursive implementation process in which there will be multiple rapid concurrent cycles of implementation, program learning (quantitative and qualitative feedback) and coverage/quality evaluation (quantitative feedback) with periodic meetings led by the government authorities to reflect on the implementation process, learnings gained, assess the model performance, and revisions to be made iteratively to the implementation model to continuously improve it. This will be followed by scaling up the optimized model concurrently in the remaining 4 blocks with contextual adaptations.

Three research teams will be involved- the Implementation Support Team (IST), Program Learning Team (PLT) and outcome monitoring team (OMT). The IST will handhold the government personnel assisting implementation and working closely with all stakeholders. Later the support will be gradually withdrawn when the government can implement it independently. The PLT, primarily a qualitative team, will assess the fidelity and adherence to program implementation, identify the barriers and facilitators to effective implementation; and inform the IST. The IST will discuss these with the government in workshop model, encourage them to take prompt corrective actions through feasible pragmatic solutions, which will be implemented subsequently. The OMT will monitor the population-based outcomes and coverage indicators through 3 monthly surveys. 

The exit time point of the research teams will be finalized with the government, NITI Aayog and the Technical Advisory Group (TAG).  The most relevant coverage and process indicators that are likely to impact the outcome indicators will be selected.  We consider a 20% increase in coverage of the indicators compared to the baseline coverage data.  The target coverage may be differential for different outcomes and will be finalized after discussions with the government partners. Considering the complexity of the intervention package and delivery of these interventions across 4 domains, a 20% improvement is reasonable. The project duration is limited. Longer duration is required to achieve a higher coverage impact. Additionally, the baseline coverage of the various indicators will vary.

Since there are multiple domains in WINGS (health, nutrition, psychosocial and WaSH). It may be noted that the target coverage of each may not be achieved concurrently at the same time point. This may happen in a phased manner. Periodic review meetings will be conducted with the state government and NITI Aayog team. The trend in coverage and outcome indicators will be monitored. 

It is anticipated that the period of model optimization of implementation strategies and having the implementation of the interventions in place, will take around 9 months. Prior to initiation of the implementation phase in each block, 3 rounds of baseline surveys will be conducted. After the intervention implementation is in place, 3 rounds of post-intervention surveys will be conducted in each block. During the implementation phase in each block, 3 monthly monitoring will be conducted. We will have multiple data points (3 baseline surveys prior to intervention initiation, ongoing 3 monthly surveys during the implementation phase and 3 post-intervention implementation surveys) to ascertain the gradient and slope for the outcome and coverage indicators.

 
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