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CTRI Number  CTRI/2020/10/028700 [Registered on: 28/10/2020] Trial Registered Prospectively
Last Modified On: 07/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Health promotion against Non-communicable diseases risk factors 
Scientific Title of Study   Vitalizing Community against Non-communicable diseases (V-CaN): a cluster field trial for health promotion against Non-communicable diseases risk factors in rural India 
Trial Acronym  V-CaN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek V Raut 
Designation  Professor 
Affiliation  Mahatma Gandhi Institute of Medical Sciences, Sevagram 
Address  Dr. Sushila Nayar School of Public Health (incorporating the Department of Community Medicine) Old hospital building, Bapu kati road, Mahatma Gandhi Institute of Medical Sciences, Sevagram

Wardha
MAHARASHTRA
442102
India 
Phone  7083170552  
Fax  07152-284333  
Email  abhishekvraut@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek V Raut 
Designation  Professor 
Affiliation  Mahatma Gandhi Institute of Medical Sciences, Sevagram 
Address  Dr. Sushila Nayar School of Public Health (incorporating the Department of Community Medicine) Old hospital building, Bapu kati road, Mahatma Gandhi Institute of Medical Sciences, Sevagram


MAHARASHTRA
442102
India 
Phone  7083170552  
Fax  07152-284333  
Email  abhishekvraut@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek V Raut 
Designation  Professor 
Affiliation  Mahatma Gandhi Institute of Medical Sciences, Sevagram 
Address  Dr. Sushila Nayar School of Public Health (incorporating the Department of Community Medicine) Old hospital building, Bapu kati road, Mahatma Gandhi Institute of Medical Sciences, Sevagram


MAHARASHTRA
442102
India 
Phone  7083170552  
Fax  07152-284333  
Email  abhishekvraut@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 
Dr Abhishek Raut  Mahatma Gandhi Institute of Medical Sciences  Room No.- 5 First floor Department of Community Medicine Old hospital building Bapu kuti road MGIMS Sevagram
Wardha
MAHARASHTRA 
7083170552

abhishekraut@mgims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Institute of Medical Sciences Sevagram Institutional Ethics Committee For Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All the young people in the 10-30 years age group irrespective of gender and socio-economic status who or whose parents/guardians give written informed consent will be included in the study.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Implementation of routine/existing government programs through the public health care delivery system for NCDs and no additional activities would be conducted in control arm during intervention phase.   The three interventions are with school students as change agents, with VHNSC members as change agents and with Women’s Self-help group (SHG) members as change agents in addition to the existing government programs for NCDs. The population in control arm will continue to receive the routine care through the existing government programs and no additional activities would be conducted in control arm. If proven effective, the health promotion strategy will also be implemented in the control PHC at the end of project.  
Intervention  School students as change agents for health promotion against NCD risk factors  In the intervention arms, the participatory health promotion strategy that will evolve through the project will be implemented. Capacity building of school students will be done through monthly contact sessions for developing NCD specific health action plan for their area/school, formation of V-CaN clubs and conduction of community-based events. 
Intervention  Village Health Nutrition and Sanitation Committees (VHNSC) as change agents for health promotion against NCD risk factors  In the intervention arms, the participatory health promotion strategy that will evolve through the project will be implemented. Capacity building of VHNSC members will be done through monthly contact sessions for developing NCD specific health action plan for their village, formation of V-CaN clubs and conduction of community-based events. 
Intervention  Women’s Self-help group (SHG) members as change agents for health promotion against NCD risk factors  In the intervention arms, the participatory health promotion strategy that will evolve through the project will be implemented. Capacity building of Women’s SHG members will be done through monthly contact sessions for developing NCD specific health action plan for their village, formation of V-CaN clubs and conduction of community-based events. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  All the young people in the 10-30 years age group irrespective of gender and socio-economic status who or whose parents/guardians give written informed consent will be included in the study. 
 
ExclusionCriteria 
Details  Young people suffering from severe illness or chronic diseases will be excluded from the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in modifiable risk factors for non-communicable diseases: obesity/pre-obesity, tobacco use, stress, unhealthy diet, physical inactivity, harmful use of alcohol, high blood pressure, high blood sugar and raised blood cholesterol.  30 months (post 24 months of intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="12000"
Sample Size from India="12000" 
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   N/A 
Date of First Enrollment (India)   01/01/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background: The key to the control of the global epidemic of NCDs is primary prevention based on comprehensive population-wide programs. In Indian context, a clear strategy of what works and how to implement it at local level is lacking.

 

Novelty: The emphasis of the proposed project is to strengthen Primary prevention of NCDs which often is neglected under the current National Health Programs. The project will be implemented in collaboration with the District Health System, utilizing the existing mechanism of VHNSC, Women’s Self-help Groups and Schools using the principles of Participatory development and therefore much more likely to be acceptable to the community and sustainable in the long run. The project will focus on young people (10-30 years) and EMPOWER and ENABLE them to exercise control on their health related behaviour and act for their own health. This age group is not covered under the NPCDCS program and it is during this phase of life that NCD risk factors are initiated and habits are formed which during later years become difficult to change and lead to chronic diseases. The three interventions are being evaluated to demonstrate the feasibility and efficacy of each of the intervention modalities as one or the other modality may not be feasible in different settings. 

 

Objective: To develop, implement and evaluate the effect of a participatory health promotion initiative against modifiable risk factors for non-communicable diseases: obesity/pre-obesity, tobacco use, stress, unhealthy diet, physical inactivity, harmful use of alcohol, high blood pressure, high blood sugar and raised blood cholesterol.

 

Methods: A cluster field trial for Health promotion will be conducted in four Primary Health Centre (PHC) area with around 140000 population. Each of the four Primary Health Centre (PHC) in the study area will be randomly allocated to one arm - namely with school students as change agents, with VHNSC members as change agents and with Women’s Self-help group (SHG) members as change agents and the control arm. Baseline and Endline assessment for prevalence of NCD risk factors namely obesity/pre-obese, tobacco use, stress, unhealthy diets, physical inactivity, harmful use of alcohol and blood pressure, blood sugar and blood cholesterol will be conducted using the WHO STEPS approach. A sample size of 12000 participants (3000 in each arm) in the 10-30 years age group has been estimated to assess the effect of intervention and will be surveyed in both Baseline and Endline assessment. Biochemical assessment will be done in a sub-sample of 1600 (400 in each arm). The Integrated Model for Social Change using community mobilization through VHNSC, Women’s SHGs and Schools will be the key health promotion strategy. V-CaN clubs will be formed in each village and schools and a V-CaN day will be organized in all the intervention villages and schools once in every 6 months.

 

Expected outcomes: The change in magnitude of modifiable NCD risk factors namely obesity/pre-obesity, tobacco use, stress, unhealthy diet, physical inactivity, harmful use of alcohol, high blood pressure, high blood sugar and raised blood cholesterol among young people will be the primary outcome. 

 
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