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CTRI Number  CTRI/2019/05/019296 [Registered on: 23/05/2019] Trial Registered Prospectively
Last Modified On: 08/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [health and education interventions]  
Study Design  Cluster Randomized Trial 
Public Title of Study   A community-based intervention study to improve newborn survival and children’s learning in rural areas of Satna District, Madhya Pradesh, India 
Scientific Title of Study   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) 
Trial Acronym  CHAMPION2/STRIPES2 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  R Harshavardhan Reddy 
Designation  Project coordinator 
Affiliation  GH Training and Consulting 
Address  GH Training and Consulting Street No 4 Basantvihar Colony Rajendra nagar
GH Training and Consulting Kakateeya Nagar, Habsiguda Hyderabad 500007 Tenengana
Satna
MADHYA PRADESH
485001
India 
Phone    
Fax    
Email  r.harsha.reddy@gmail.com  
 
Details of Contact Person
Public Query  
Name  R Harshavardhan Reddy 
Designation  Project coordinator 
Affiliation  GH Training and Consulting 
Address  GH Training and Consulting Street No 4 Basantvihar Colony Rajendra nagar
GH Training and Consulting Kakateeya Nagar, Habsiguda Hyderabad 500007 Tenengana
Satna
MADHYA PRADESH
485001
India 
Phone    
Fax    
Email  r.harsha.reddy@gmail.com  
 
Source of Monetary or Material Support  
Effective Intervention UK registered charity no 1111709 
 
Primary Sponsor  
Name  Effective Intervention 
Address  Centre for Economic Performance London School of Economics Houghton Street London WC2A2AE 
Type of Sponsor  Other [UK registered charity no 1111709] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
R Harshavardhan Reddy  Satna District  Satna district Madhya Pradesh India
Satna
MADHYA PRADESH 		 9644003811

r.harsha.reddy@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
LV Prasad Eye Institute Ethics Committee  Approved 
LV Prasad Eye Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnancy and children aged under 6 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control for CHAMPION2  STRIPES 2 intervention as well as the usual health services provided by the government and other Non-Governmental Organisations (NGOs).  
Comparator Agent  Control for STRIPES2  CHAMPION 2 intervention as well as the usual education services provided by the government and other NGOs  
Intervention  Education intervention for STRIPES2  1. Warm up phase: Trained instructor interacts with eligible children through playing, singing, colouring, and drawing 2.After school teaching lessons for eligible children for two hours, six days a week by a trained instructor 3. Orientation to engagement activities (door- to- door meetings, community events and creation of mothers’ groups)for mothers of children to promote their attendance and learning. 
Intervention  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.Effective coordination of referrals 4.Strengthening of Healthcare services at Community Health Centres according to National Health Mission standards  
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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




 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
CHAMPION 2- neonatal mortality
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  
Outcome  TimePoints 
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

 
 
Target Sample Size   Total Sample Size="20000"
Sample Size from India="20000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/06/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 1.Agarwal, A., Banerji, R., Boone, P. et al. Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2). Trials 21, 569 (2020). https://doi.org/10.1186/s13063-020-04339-6 2.Keddie, S., Fazzio, I., Shivalli, S. et al. Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2). Trials 24, 469 (2023). https://doi.org/10.1186/s13063-023-07453-3 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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.

 

 

 

 

 
 
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