SPRING Cluster Randomised Controlled Trial
SPRING
SPRING (for the Millennium Development Goals): Sustainable Programme Incorporating Nutrition and Games (for Maximising Development, Growth and Survival)
2 other identifiers
interventional
12,000
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedAugust 24, 2017
August 1, 2017
3.6 years
February 10, 2014
August 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
infant mortality
the % of newborns who die during the first year of life
the first year of life
stunting
% children stunted, with stunting defined as below -2 standard deviations of height for age using the WHO growth standards
18-24 months
child development
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.
18-24 months of age
maternal psychosocial distress/depression
assessed using the 9 item Patient Health Questionnaire
6-12 months postpartum
Secondary Outcomes (4)
% adopting key promoted behaviours
from pregnancy up to age 2
wasting
18-24 months of age
underweight
18-24 months of age
age-specific infant mortality
during the first year of life
Study Arms (2)
SPRING intervention clusters
EXPERIMENTALSPRING 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
Control clusters
NO INTERVENTIONaccess to routine maternal and child health services
Interventions
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
Eligibility Criteria
You may qualify if:
- All liveborn babies whose mothers reside within the trial evaluation zones
You may not qualify if:
- major congenital malformation
- maternal death in neonatal period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- University of Liverpoolcollaborator
- University College, Londoncollaborator
- Human Development Research Foundation, Pakistancollaborator
- Sangathcollaborator
Study Sites (2)
Sangath: Haryana field site
Porvorim, Goa, 403501, India
Human Development Research Foundation: Rawalpindi field site
Islamabad, Punjab Province, 44000, Pakistan
Related Publications (2)
Zafar S, Sikander S, Haq Z, Hill Z, Lingam R, Skordis-Worrall J, Hafeez A, Kirkwood B, Rahman A. Integrating maternal psychosocial well-being into a child-development intervention: the five-pillars approach. Ann N Y Acad Sci. 2014 Jan;1308:107-117. doi: 10.1111/nyas.12339.
PMID: 24571213BACKGROUNDLingam R, Gupta P, Zafar S, Hill Z, Yousafzai A, Iyengar S, Sikander S, Haq ZU, Mehta S, Skordis-Worrel J, Rahman A, Kirkwood B. Understanding care and feeding practices: building blocks for a sustainable intervention in India and Pakistan. Ann N Y Acad Sci. 2014 Jan;1308:204-217. doi: 10.1111/nyas.12326. Epub 2014 Jan 6.
PMID: 24392960BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Betty Kirkwood, MSc, FMedSci
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2014
First Posted
February 11, 2014
Study Start
March 1, 2014
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
August 24, 2017
Record last verified: 2017-08