SPRING (for the Millennium Development Goals): Sustainable Programme Incorporating Nutrition and Games (for Maximising Development, Growth and Survival)
试验速览
- 阶段
- 不适用
- 入组人数
- 12,000
- 试验地点
- 4
- 主要终点
- infant mortality
研究概览
简要总结
A large number of children in developing countries lack access to known effective interventions. Almost 9 million die each year before reaching their fifth birthday, and over 200 million children who survive fail to achieve their full growth or developmental potential, trapping them in a cycle of continuing disadvantage. The goal of "SPRING", Sustainable Programme Incorporating Nutrition and Games, is to develop an innovative approach to close this access gap, in two of the worst affected countries India and Pakistan, using community based agents. Extensive formative research will be carried out to help ensure that the content and approach of the "SPRING" intervention is feasible, acceptable and appropriately targeted. Findings will be reviewed at an intervention development workshop with local and international stakeholders and experts, and the agreed intervention piloted with a few community based agents and their supervisors. Cluster randomised controlled trials will be carried out in each setting to evaluate the impact of "SPRING" on child growth, development and survival. The programme will include process and economic evaluations to provide information on the total cost of the intervention and its cost effectiveness, as well as development of a framework with lessons learned for implementing "SPRING" in other settings.
详细描述
The goal of "SPRING", Sustainable Programme Incorporating Nutrition and Games, is to develop an innovative, feasible, affordable and sustainable community based approach that can achieve delivery at scale of known effective interventions that will maximise child development, growth and survival. The vision is to do this by working in close collaboration with government programmes in India and Pakistan, and modifying the approach, content and supervision of existing community based programmes to develop an innovative intervention package that
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Is designed from the outset to be feasible, affordable and appropriate for delivery at scale.
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Is delivered by low cost community based agents through home visits from pregnancy through the first 2 years of life, which
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promote evidence based newborn and child survival interventions
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use a problem solving and counselling approach, rather than the standard didactic approach, using techniques informed by evidence from the cognitive behaviour and interpersonal psychotherapy fields.
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teach care giving skills, such as early recognition of infant signals and capacity, enhancing mother baby interactions, providing stimulation for cognitive growth and development.
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support optimal infant and young child feeding practices.
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encourage participation of other family members, e.g. fathers and grandmothers.
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is informed by the Care for Development Package developed by the World Health Organization (WHO) and the United Nations International Emergency Children's Fund.
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Includes regular supervision, monitoring and evaluation to support the community based agents and ensure the quality of the intervention activities carried out.
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Includes a range of supporting activities developed to provide an enabling environment for mothers and families to carry out the interventions and skills promoted. These might include, for example, community group meetings, and sensitisation sessions with health staff.
The specific objectives of "SPRING" are
- To test this intervention package through cluster randomised controlled trials in two settings, one in India and one in Pakistan, both with high rates of undernutrition and well established but somewhat different community based agent programmes.
- To evaluate the impact of the intervention on Infant mortality, child development and growth Maternal psychosocial distress. Coverage of key promoted interventions.
- To evaluate and monitor all aspects of the intervention process and implementation
- To cost the delivery of the intervention, and assess its cost effectiveness.
- To assess the effectiveness of the intervention in reducing inequities in trial outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All liveborn babies whose mothers reside within the trial evaluation zones
排除标准
- •major congenital malformation
- •maternal death in neonatal period
研究组 & 干预措施
SPRING intervention clusters
SPRING package: Home visits by community based agents carried out from pregnancy to 2 years of age to encourage key behaviours to promote child growth, survival and development together with regular supervision
PLUS access to routine maternal and child health services
干预措施: SPRING (Behavioral)
Control clusters
access to routine maternal and child health services
结局指标
主要结局
infant mortality
时间窗: the first year of life
the % of newborns who die during the first year of life
stunting
时间窗: 18-24 months
% children stunted, with stunting defined as below -2 standard deviations of height for age using the WHO growth standards
child development
时间窗: 18-24 months of age
a range of psychometric outcome measures covering several domains including cognition, motor, language, and psychosocial development plus maternal-child interaction and quality of the home environment.
maternal psychosocial distress/depression
时间窗: 6-12 months postpartum
assessed using the 9 item Patient Health Questionnaire
次要结局
- wasting(18-24 months of age)
- underweight(18-24 months of age)
- age-specific infant mortality(during the first year of life)
- % adopting key promoted behaviours(from pregnancy up to age 2)