跳至主要内容
临床试验/CTRI/2023/10/058538
CTRI/2023/10/058538尚未招募不适用

WINGS Scale Up in Himachal Pradesh

Centre for Health Research and Development Society for Applied Studies1 个研究点 分布在 1 个国家目标入组 75,000 人开始时间: 2023年1月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
75,000
试验地点
1
主要终点
To develop a framework and guide the government partners with a clean action plan to scale up the WINGS integrated interventions in a selected district of Himachal Pradesh, that will be sustainable, scalable, and achieve high population-based coverage with quality.

研究概览

简要总结

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: Please note that in implementation research the aim is to include the entire target population of the district, that is, preconception and pregnant women in entire district. Therefore, a sample size cannot be specified in implementation research. In district Una the total population is about 5 lakhs, eligible couples are expected to be around 75000 women to whom the intervention will need to be delivered by the government.

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Preconception women in reproductive age group with no or one child, pregnant women, children less than 2 years of age and their family members.

排除标准

  • 未提供

结局指标

主要结局

To develop a framework and guide the government partners with a clean action plan to scale up the WINGS integrated interventions in a selected district of Himachal Pradesh, that will be sustainable, scalable, and achieve high population-based coverage with quality.

时间窗: Throughout the period of 3 years

o Proportion of women who are non-anemic.

时间窗: Throughout the period of 3 years

o Proportion of women with BMI between 18.5 to 24.99 kg/m2

时间窗: Throughout the period of 3 years

Infants

时间窗: Throughout the period of 3 years

o Proportion of infants with adequate weight gain from birth till 1 year of age

时间窗: Throughout the period of 3 years

Preconception women defined as married women in reproductive age group who have not completed their families.

时间窗: Throughout the period of 3 years

o Proportion of women with adequate gestational weight gain

时间窗: Throughout the period of 3 years

Pregnant women

时间窗: Throughout the period of 3 years

o Proportion of women with normal thyroid levels in pregnancy

时间窗: Throughout the period of 3 years

次要结局

  • Additionally, we will monitor coverage indicators and process indicators, through 3 monthly monitoring during the implementation phase and 3 rounds of surveys post intervention.(Preconception period)
  • Postnatal(o mothers receiving and consuming nutritional supplements (medicines and food))
  • Activities to create awareness and generate demand(o Social Behavioral Change Communication (SBCC) activities conducted as planned)
  • Pregnancy(o women registering for ANC in the 1st trimester.)
  • Infants(o Infants 0-6 months exclusively breastfed (EBF), received kangaroo mother care (KMC) as applicable)
  • Psychosocial and WaSH interventions(o Eligible women who received appropriate psychosocial support)

研究者

申办方类型
Other [Not for profit research organization]

研究点 (1)

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