SPRING Cluster Randomised Controlled Trial

NCT02059863 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12000

Last updated 2017-08-24

No results posted yet for this study

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.

Conditions

  • Growth; Stunting, Nutritional
  • Child Development
  • Depression, Postpartum
  • Death

Interventions

BEHAVIORAL

SPRING

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

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER
  • University College, London

    collaborator OTHER
  • Human Development Research Foundation, Pakistan

    collaborator OTHER
  • Sangath

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Betty Kirkwood, MSc, FMedSci · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • India
  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059863 on ClinicalTrials.gov