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CTRI Number  CTRI/2024/07/071102 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   A study to check whether lifestyle changes helps in reducing the future risk of cardiovascular illness among the adolescents and young adults. 
Scientific Title of Study   Structured Health interventions to reduce Cardiometabolic Risk among adolescents and young adults in tribal communities in Meghalaya, North-eastern India. A type 2 hybrid Cluster- Randomized Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Felix Jebasingh K 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8098469771  
Fax    
Email  felixjebasingh@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Felix Jebasingh K 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore


TAMIL NADU
632004
India 
Phone  8098469771  
Fax    
Email  felixjebasingh@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Felix Jebasingh K 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore


TAMIL NADU
632004
India 
Phone  8098469771  
Fax    
Email  felixjebasingh@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
National Health and Medical Research Council (NHMRC), Australia 
 
Primary Sponsor  
Name  National Health and Medical Research Council (NHMRC), Australia 
Address  National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601 Australia 
Type of Sponsor  Other [Government Funding agency-Australia] 
 
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 Meban Aibor Kharkongor  Dr H Gordon Roberts hospital  Department of Medicine, Jaiaw, Shillong.793002
East Khasi Hills
MEGHALAYA 		 7904982585

mebanaibor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
CMCETHICSCOMMITTEE/IRB  Approved 
DRHGRHETHICS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health Volunteers who have at least one family member having history of Diabetes, Hypertension or any cardio vascular equivalent 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional arm  Adolescents and young adults will not be given any intensive behavioral changes regarding any lifestyle modification and will be asked to follow their existing healthy lifestyle they practice 
Intervention  Lifestyle modification  Lifestyle modification to prevent future risk of obesity, diabetes, hypertension and cardiovascular diseases 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  The target population for the community level interventions will be all
adolescents and young adults in that community, and for the family and individual level
interventions, they will be adolescents and young adults living in at-risk households. We
define at-risk households as those which we have already been previously identified from
our other ongoing research as having at least one family member with diabetes,
hypertension, obesity, dyslipidemia and/or a history of cardiovascular disease in the past 
 
ExclusionCriteria 
Details  Participants will be excluded if they have prior diagnosis of
cardiovascular diseases, cancer, epilepsy, arthritis or dementia, or have other conditions
that limit physical activity and dietary habits. Pregnant women will also be excluded.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of interest is ideal/improved cardiometabolic health as
measured by American Heart Association’s Life’s Simple, which has been adapted
and used in South Asian countries.  		 At the end of the study at 5 years 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measures will include continuous and
categorical measurements of fruit and vegetable consumption, physical activity, waist
circumference, smoking, body mass index, blood glucose level, blood pressure and lipid
levels and metabolic syndrome. 		 At the end of the study at 5 years 
 
Target Sample Size   Total Sample Size="4110"
Sample Size from India="4110" 
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/ Phase 4 
Date of First Enrollment (India)   02/09/2024 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The proposed research study aims to adapt, implement, and evaluate evidence-based lifestyle intervention program to improve cardiometabolic health among adolescents and young adults in tribal populations of rural Meghalaya, a North-eastern state in India. This study will be undertaken in 40 villages of East Khasi Hills district in Meghalaya, a Northeastern state in India.

We have planned to undertake a hybrid type 2 cluster-randomized trial to evaluate both the effectiveness of the intervention program as well as implementation strategies and outcomes. A cluster-randomized trial will enable comparison of the outcomes between the intervention and control clusters in the real-world setting. The target population will be all adolescents and young adults in that community whose family has at least one cardiovascular risk factor such as Obesity or Diabetes, or hypertension or history of Coronary Artery Disease (CAD) or Cerebrovascular Accident (CVA) After a baseline assessment (Includes baseline anthropometric measures, blood for glucose, growth assessment with growth chart, Lipids, and body composition), the proposed intervention will be implemented over an 18-month period, after which the outcomes will be assessed over a period of up to three years further. Twenty clusters (villages) will be each randomly assigned to the intervention and control conditions. The villages are all from the predominantly tribal populations living in sub district East Khasi hills of Meghalaya. We will implement Community health worker (CHW)-led multicomponent interventions at villages to create an environment that supports the adoption of healthy lifestyle.  
 
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