- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02059863
SPRING Cluster Randomised Controlled Trial (SPRING)
SPRING (for the Millennium Development Goals): Sustainable Programme Incorporating Nutrition and Games (for Maximising Development, Growth and Survival)
Study Overview
Status
Intervention / Treatment
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
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Goa
-
Porvorim, Goa, India, 403501
- Recruiting
- Sangath: Haryana field site
-
Contact:
- Gauri Divan, MD
- Phone Number: +919881722551
- Email: gauridivan@gmail.com
-
Principal Investigator:
- Gauri Divan, MD
-
-
-
-
Punjab
-
Islamabad, Punjab, Pakistan, 44000
- Not yet recruiting
- Human Development Research Foundation: Rawalpindi field site
-
Contact:
- Siham Sikander, MD, PhD
- Phone Number: +92512656172
- Email: siham.sikander@hdrfoundation.org
-
Principal Investigator:
- Siham Sikander, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All liveborn babies whose mothers reside within the trial evaluation zones
Exclusion Criteria:
- major congenital malformation
- maternal death in neonatal period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 |
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:
|
No Intervention: Control clusters
access to routine maternal and child health services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
infant mortality
Time Frame: the first year of life
|
the % of newborns who die during the first year of life
|
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
|
18-24 months
|
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.
|
18-24 months of age
|
maternal psychosocial distress/depression
Time Frame: 6-12 months postpartum
|
assessed using the 9 item Patient Health Questionnaire
|
6-12 months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% adopting key promoted behaviours
Time Frame: from pregnancy up to age 2
|
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.
|
18-24 months of age
|
underweight
Time Frame: 18-24 months of age
|
% children below the -2 standard deviations for weight for age using the WHO growth standards.
|
18-24 months of age
|
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
|
during the first year of life
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Betty Kirkwood, MSc, FMedSci, London School of Hygiene and Tropical Medicine
Publications and helpful links
General 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;1308:107-17. doi: 10.1111/nyas.12339.
- 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;1308:204-17. doi: 10.1111/nyas.12326. Epub 2014 Jan 6.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPNPBE2610
- 093615 (Other Grant/Funding Number: Wellcome Trust)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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