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Growth; Stunting, NutritionalSPRINGNCT02059863

SPRING Cluster Randomised Controlled Trial

A study testing SPRING in people with Growth; Stunting, Nutritional and Child Development, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 day to 24 months
What is being tested?
SPRING
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12,000 participants
Where
2 sitesin 2 countries
Study dates
Mar 2014to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • major congenital malformation
  • maternal death in neonatal period

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

India1 site, 1 recruiting

  • Sangath: Haryana field site

    Porvorim, Goa, 403501

    Gauri Divan, MD, +919881722551, gauridivan@gmail.com

    Gauri Divan, MD

    Recruiting

Other trials in India

Pakistan1 site, 1 recruiting

  • Human Development Research Foundation: Rawalpindi field site

    Islamabad, Punjab Province, 44000

    Siham Sikander, MD, PhD, +92512656172, siham.sikander@hdrfoundation.org

    Siham Sikander, MD, PhD

    Not yet recruiting

Other trials in Pakistan

About this study

Official title: SPRING (for the Millennium Development Goals): Sustainable Programme Incorporating Nutrition and Games (for Maximising Development, Growth and Survival)

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.

Read the 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.
Being tested
SPRING
Keywords
cluster randomised trial, low and middle income countries, community based intervention, complex intervention
Medical subject headings
Growth Disorders, Depression, Postpartum, Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPRINGBehavioural

    Also called Pakistan: Roshan Kal, India: Kilkaari (to be confirmed)

    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

Study groups in NCT02059863
Study groupRoleWhat they receive
SPRING intervention clustersExperimentalSPRING 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
Receives: Behavioral: SPRING
Control clustersNo interventionaccess to routine maternal and child health services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. infant mortality

    the % of newborns who die during the first year of life

    Measured: the first year of life

  2. stunting

    % children stunted, with stunting defined as below -2 standard deviations of height for age using the WHO growth standards

    Measured: 18-24 months

  3. 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.

    Measured: 18-24 months of age

  4. maternal psychosocial distress/depression

    assessed using the 9 item Patient Health Questionnaire

    Measured: 6-12 months postpartum

Secondary outcomes (4)

  1. % adopting key promoted behaviours

    Measured: from pregnancy up to age 2

  2. wasting

    % children below -2 standard deviations for weight for height using the WHO growth standards.

    Measured: 18-24 months of age

  3. underweight

    % children below the -2 standard deviations for weight for age using the WHO growth standards.

    Measured: 18-24 months of age

  4. age-specific infant mortality

    % babies who die within the following periods after birth: <1 week, 1-3 weeks, 1st month,1-5 months, 6-11 months

    Measured: during the first year of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionOct 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059863
Sponsor's protocol ID
EPNPBE2610
Other IDs
093615
Acronym
SPRING
Status last verified
Aug 2017
First submitted
10 Feb 2014
Last updated
24 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24571213

  • Lingam 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.

    PubMed 24392960

Questions about this trial

What is this clinical trial studying?

A study testing SPRING in people with Growth; Stunting, Nutritional and Child Development, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

infant mortality (time frame: the first year of life). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02059863, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.

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