A community-based intervention study to improve newborn survival and children’s learning in rural areas of Satna District, Madhya Pradesh, India
- Conditions
- Pregnancy and children aged under 6 years
- Registration Number
- CTRI/2019/05/019296
- Lead Sponsor
- Effective Intervention
- Brief Summary
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|Background: Health care and primary education in India continues to have poor outcomes with large disparities between rural and urban regions as well as between the wealthiest and poorest populations. High neonatal mortality rates and low levels of literacy and numeracy are endemic in rural areas.
This study aims to assess simultaneously the effect of a health intervention on neonatal survival as well as an education intervention on literacy and numeracy scores. Based on lessons learnt from original CHAMPION/STRIPES trial and relevant evidence generated since the conception of the original trial, CHAMPION 2/STRIPES 2 design will be further developed and contextualized to socio-cultural patterns in Madhya Pradesh, India.
Methods/design: A cluster-randomised controlled trial where villages will be randomised to receive either a health (CHAMPION 2) or education (STRIPES 2) intervention. Villages randomised to receive the health intervention will serve as controls for the education intervention and conversely, villages randomised to receive the educational intervention will serve as controls for the health intervention.
Clusters: 196 villages in Satna district, Madhya Pradesh India with less than 2,500 people, and not within a five kilometer radius of a Community Health Centre/Civil Hospital, and with 15 or more children eligible for the education intervention will be selected for the trial.
Participants: In CHAMPION 2, women will be eligible if they meet the following criteria: resident in selected villages; married women enumerated at baseline (or newly married to a man who was enumerated at baseline); under 50 years of age; and who (and whose husband) has not had a family planning operation.
In STRIPES 2, participants will be children resident in eligible villages, born between the 16th of June 2010 and 15th of June 2013, and (at baseline) intending to enroll in the first grade in the 2018 - 2019 school year.
Interventions: The study design is adapted and further developed from the CHAMPION/STRIPES trial in Telangana. In CHAMPION 2 accredited Social Health Activists (ASHAs) or village health workers (VHWs) and midwives will promote health knowledge and provide healthcare through the following activities: antenatal, postnatal and neonatal care provided at a chosen community centre; community mobilisation; coordinating referrals to appropriate government health facilities; and a health education campaign through theatre, films and other media. The NICE Foundation will be strengthening selected Community Health Centres (CHC) to ensure they meet essential services criteria as is defined by the National Health Mission, Government of India. The CHAMPION 2 intervention is expected to run for three years.
Adapted and further developed from the STRIPES trial in Telangana, the STRIPES 2 programme will offer eligible children village-based after-school support provided by a trained Pratham instructor focusing on literacy and numeracy skills, six days a week during two successive academic years.
COVID-19 amendments: Trial interventions and data collection activities were suspended in March 2020 in line with the government lockdown due to the COVID-19 pandemic. Following the restart of the trial in June-September2020 in a phased manner, interventions, data collection methods, and timelines were modified to reduce the risk of COVID-19 transmission. Some trial activities were suspended again from April-May 2021 due to second wave of COVID-19 cases. CHAMPION2: Initially outcome measurement timeline was for 30 months from 19 June 2020, which was changed to 30 months from 1 January 2021. Further, due to COVID-19 pandemic we gathered information from participants as much as possible by telephone. If the participant did not have a telephone or could not be contacted by telephone, data were collected in person by visiting the household. STRIPES2 intervention was extended by a little over a year with the endline test carried out from July- September 2022 rather than April-May 2021 as had been initially planned.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 20000
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CHAMPION 2- neonatal mortality CHAMPION 2-neonatal deaths between 12 months and 42 months after randomisation | STRIPES 2- At the end of 2 academic years after randomisation STRIPES 2- composite maths and reading literacy and numeracy test score CHAMPION 2-neonatal deaths between 12 months and 42 months after randomisation | STRIPES 2- At the end of 2 academic years after randomisation
- Secondary Outcome Measures
Name Time Method Maternal mortality between 12 months and 42 months after randomisation Neonatal and maternal causes of death between 12 months and 42 months after randomisation Stillbirths and perinatal deaths between 12 months and 42 months after randomisation Antenatal care (e.g. number of antenatal care visits, antenatal care provided; care provider) between 12 months and 42 months after randomisation Delivery care (e.g. use of skilled birth attendant, place of delivery, clean delivery practices) between 12 months and 42 months after randomisation Postnatal care (e.g. umbilical cord care, thermal care, breastfeeding, care seeking) between 12 months and 42 months after randomisation Health knowledge between 12 months and 42 months after randomisation Hospital admissions (other than for delivery) of enrolled women during pregnancy or afterwards, or their babies between 12 months and 42 months after randomisation Significant disability/incapacity or congenital anomalies of enrolled women during pregnancy or afterwards, or their babies, evident during the period of data collection between 12 months and 42 months after randomisation Cost effectiveness of CHAMPION 2 intervention between 12 months and 42 months after randomisation Separate scores for literacy and numeracy 2 years 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 enrolment 2 years after randomisation Cost effectiveness of STRIPES 2 intervention 2 years after randomisation
Trial Locations
- Locations (1)
Satna District
🇮🇳Satna, MADHYA PRADESH, India
Satna District🇮🇳Satna, MADHYA PRADESH, IndiaR Harshavardhan ReddyPrincipal investigator9644003811r.harsha.reddy@gmail.com