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A community-based intervention study to improve newborn survival and children’s learning in rural areas of Satna District, Madhya Pradesh, India

Cluster randomized trial in Madhya Pradesh, India: Community health promotion and medical provision and impact on neonates (CHAMPION 2); and support to rural India’s public education system and impact on numeracy and literacy (STRIPES 2) - CHAMPION2/STRIPES2

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019296
Enrollment
20000
Registered
2019-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Health intervention for CHAMPION2: 1.Health promotion and community mobilization by ASHAs (Accredited Social Health Activist) 2.Fixed day health services by Nurse Midwife and ASHAs 3.Ef

Sponsors

Effective Intervention
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Selection of villages in seven sub-districts (Tehsils) of Satna: 1.Rural village with less than 2500 population and with more than 120 children under the age of 6 2.accessible by road; 3.not within a 5 kilometres radius of the Community Health Centres 4.has a minimum of 3 kilometres between them to avoid contamination For CHAMPION 2, a woman is eligible if 1.She is married; 2.Neither she nor her husband have had a family planning operation i.e. male or female sterilisation tubectomy or vasectomy, respectively 3.She is less than 50 years old 4.She is resident in one of the trial villages at the time of the baseline survey 5.She gives her consent after getting a complete explanation of the study 6. she marries a man who was enumerated and unmarried at the time of enumeration, determined to be unmarried, resident in the village, and aged between 13 and 50 years For STRIPES 2, a child is eligible to participate if: 1.S/he was born between 10th 16th June 2010 and 15th 1st July June 2013 2.S/he is not yet enrolled in primary school 3.S/he is expected to be resident in the village and be enrolled in school for the first time, in the first grade in the academic year of 2018-2019 4.Her/his parents agree that s/he participates after hearing the explanation about the programme and its evaluation tests

Exclusion criteria

Exclusion criteria: 1. Village with less than 15 eligible children for STRIPES 2 2. For CHAMPION2, woman who is not enumerated or get married to a man who is not enumerated or whose marriage date precedes the date of their village enumeration 3.For CHAMPION2, woman (and their babies) who move to a trial village for other reasons (e.g. their mother’s residence for delivery of their baby) 3.For STRIPES 2, children who move into the trial village after the enumeration

Design outcomes

Primary

MeasureTime frame
CHAMPION 2- neonatal mortality STRIPES 2- composite maths and reading literacy and numeracy test score Timepoint: CHAMPION 2-neonatal deaths between 12 months and 42 months after randomisation STRIPES 2- At the end of 2 academic years after randomisation

Secondary

MeasureTime frame
Antenatal care (e.g. number of antenatal care visits, antenatal care provided; care provider)Timepoint: between 12 months and 42 months after randomisation;Cost effectiveness of CHAMPION 2 interventionTimepoint: between 12 months and 42 months after randomisation;Cost effectiveness of STRIPES 2 interventionTimepoint: 2 years after randomisation ;Delivery care (e.g. use of skilled birth attendant, place of delivery, clean delivery practices)Timepoint: between 12 months and 42 months after randomisation;Health knowledgeTimepoint: between 12 months and 42 months after randomisation;Hospital admissions (other than for delivery) of enrolled women during pregnancy or afterwards, or their babiesTimepoint: between 12 months and 42 months after randomisation;Maternal mortalityTimepoint: between 12 months and 42 months after randomisation;Neonatal and maternal causes of deathTimepoint: between 12 months and 42 months after randomisation;Postnatal care (e.g. umbilical cord care, thermal care, breastfeeding, care seeking)Timepoint: between 12 months and 42 months after randomisation;Scores in specific reading and mathsliteracy and numeracy domains (reading: oral vocabulary, listening comprehension, letter identification, non-word reading, familiar-word reading, paragraph reading fluency with comprehension, dictation and maze/cloze, and for maths:, missing number, addition and , subtraction – level 1 and 2, and word problems, geometric shape and pattern recognition), school attendance (reported by parents) and enrolmentTimepoint: 2 years after randomisation ;Separate scores for literacy and numeracyTimepoint: 2 years after randomisation ;Significant disability/incapacity or congenital anomalies of enrolled women during pregnancy or afterwards, or their babies, evident during the period of data collectionTimepoint: between 12 months and 42 months after randomisation;Stillbirths and perinatal deathsTimepoint: between 12 months and 42 months after randomisa

Countries

India

Contacts

Public ContactR Harshavardhan Reddy

GH Training and Consulting

r.harsha.reddy@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 27, 2026