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SPRING Cluster Randomised Controlled Trial (SPRING)

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ClinicalTrials.gov Identifier: NCT02059863
Recruitment Status : Unknown
Verified August 2017 by London School of Hygiene and Tropical Medicine.
Recruitment status was:  Recruiting
First Posted : February 11, 2014
Last Update Posted : August 24, 2017
Sponsor:
Collaborators:
University of Liverpool
University College, London
Human Development Research Foundation, Pakistan
Sangath
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE February 10, 2014
First Posted Date  ICMJE February 11, 2014
Last Update Posted Date August 24, 2017
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
  • infant mortality [ Time Frame: the first year of life ]
    the % of newborns who die during the first year of life
  • stunting [ Time Frame: 18-24 months ]
    % children stunted, with stunting defined as below -2 standard deviations of height for age using the WHO growth standards
  • child development [ Time Frame: 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 [ Time Frame: 6-12 months postpartum ]
    assessed using the 9 item Patient Health Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
  • % adopting key promoted behaviours [ Time Frame: from pregnancy up to age 2 ]
  • wasting [ Time Frame: 18-24 months of age ]
    % children below -2 standard deviations for weight for height using the WHO growth standards.
  • underweight [ Time Frame: 18-24 months of age ]
    % children below the -2 standard deviations for weight for age using the WHO growth standards.
  • age-specific infant mortality [ Time Frame: during the first year of life ]
    % babies who die within the following periods after birth: <1 week, 1-3 weeks, 1st month,1-5 months, 6-11 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPRING Cluster Randomised Controlled Trial
Official Title  ICMJE SPRING (for the Millennium Development Goals): Sustainable Programme Incorporating Nutrition and Games (for Maximising Development, Growth and Survival)
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.
Detailed Description

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

  • Is designed from the outset to be feasible, affordable and appropriate for delivery at scale.
  • Is delivered by low cost community based agents through home visits from pregnancy through the first 2 years of life, which

    • promote evidence based newborn and child survival interventions
    • 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.
    • teach care giving skills, such as early recognition of infant signals and capacity, enhancing mother baby interactions, providing stimulation for cognitive growth and development.
    • support optimal infant and young child feeding practices.
    • encourage participation of other family members, e.g. fathers and grandmothers.
    • is informed by the Care for Development Package developed by the World Health Organization (WHO) and the United Nations International Emergency Children's Fund.
  • Includes regular supervision, monitoring and evaluation to support the community based agents and ensure the quality of the intervention activities carried out.
  • 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

  1. 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.
  2. To evaluate the impact of the intervention on Infant mortality, child development and growth Maternal psychosocial distress. Coverage of key promoted interventions.
  3. To evaluate and monitor all aspects of the intervention process and implementation
  4. To cost the delivery of the intervention, and assess its cost effectiveness.
  5. To assess the effectiveness of the intervention in reducing inequities in trial outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Growth; Stunting, Nutritional
  • Child Development
  • Depression, Postpartum
  • Death
Intervention  ICMJE 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
Other Names:
  • Pakistan: Roshan Kal
  • India: Kilkaari (to be confirmed)
Study Arms  ICMJE
  • Experimental: 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

    Intervention: Behavioral: SPRING
  • No Intervention: Control clusters
    access to routine maternal and child health services
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
12000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All liveborn babies whose mothers reside within the trial evaluation zones

Exclusion Criteria:

  • major congenital malformation
  • maternal death in neonatal period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Day to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02059863
Other Study ID Numbers  ICMJE EPNPBE2610
093615 ( Other Grant/Funding Number: Wellcome Trust )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party London School of Hygiene and Tropical Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Liverpool
  • University College, London
  • Human Development Research Foundation, Pakistan
  • Sangath
Investigators  ICMJE
Principal Investigator: Betty Kirkwood, MSc, FMedSci London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP