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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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30 April 2018 |
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Main ID: |
ISRCTN10412166 |
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Date of registration:
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26/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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1000 Dreams: a community-based integrated early life intervention program to help babies survive and thrive
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Scientific title:
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1000 Dreams: a community-based integrated early life intervention program to help babies survive and thrive |
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Date of first enrolment:
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01/10/2015 |
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Target sample size:
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1056 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN10412166 |
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Study type:
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Interventional |
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Study design:
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Cluster randomized controlled trial (Prevention)
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Aarti
Kumar |
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Address:
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Community Empowerment Lab
226001
Lucknow
India |
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Telephone:
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+91-9450607023 |
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Email:
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swati.dixit@shivgarh.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. All pregnant women who are identified in the first, second or early third trimester, and reside in the village of identification till the baby is at least 6 months of age will be considered as eligible for analysis of trial outcomes.
2. All women/babies who are found to be residing in a particular cluster at the time of first identification will be analyzed as part of the same cluster, irrespective of migration after the baby is 6 months of age, as per principles of intention to treat.
Exclusion criteria: Inclusion criteria not met
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Newborn survival and child development
Pregnancy and Childbirth
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Intervention(s)
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24 clusters (village administrative units) were randomly allocated equally to intervention or control prior to initiation of enrollment. A restricted randomization approach, balancing the population of clusters and proportion of lower castes, was adopted to ensure balanced allocation. The two allocation sequences generated through the restricted randomization scheme were allocated to intervention and control by a community member through the toss of a coin. Due to the nature of the intervention (home visitations by special workers called 'life coaches', etc), it was not possible to mask the intervention clusters. However, the entire evaluation was conducted by a separate set of workers, following the same process in both intervention and control clusters. The intervention package included counselling and handholding support for pregnant women and their families on nutrition (during pregnancy, lactation and complementary feeding), hygiene, early child stimulation including massage and play, early initiation of skin-to-skin contact for all babies, and care-seeking. The intervention was designed around 6 domains (Nutrition, Hygiene & Infection Prevention, Infant Massage, Loving and Responsive Care Practices, Active Stimulation & Interaction and Care Seeking).
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Primary Outcome(s)
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1. Infant mortality rate
2. Stunting (as measured at 6, 9 and 12 months of age)
3. Developmental scores (as measured at 6 and 9 months of age)
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Secondary Outcome(s)
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1. Neonatal mortality rate
2. Infant mortality rate
3. Mean birth weight
4. Rates of exclusive breastfeeding at 6 months
5. Prevalence of maternal depression
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Secondary ID(s)
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CELIEC/2015001
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Source(s) of Monetary Support
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Canadian Government
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Ethics review
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Status:
Approval date:
Contact:
CELIEC (Community Empowerment Lab Institutional Ethics Committee), CELIEC/2015001
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/12/2016 |
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URL:
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