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
|
|
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
|
|
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. |