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CTRI Number  CTRI/2025/08/092529 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Testing a Lifestyle Toolkit to Improve Health for People with Multiple Health Problems Related to Heart and Metabolism 
Scientific Title of Study   Effectiveness of a lifestyle toolkit in improving health outcomes in individuals with cardio-metabolic multi-morbidity and inter-generational prevention; a cluster rondomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jaideep C Menon 
Designation  Professor , Adult Cardiology and Public health 
Affiliation  Amrita Institute of Medical Sciences 
Address  Kailash, KTN 168A, Kothakulangara Temple road, Angamaly
Department of Cardiology, Preventive Cardiology, Room number 6, Amrita Institute of Medical Sciences, Ponnekkara PO Edapally, Ernakulam, Kerala
Ernakulam
KERALA
683572
India 
Phone  9895122099  
Fax    
Email  menon7jc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jaideep C Menon 
Designation  Professor , Adult Cardiology and Public health 
Affiliation  Amrita Institute of Medical Sciences 
Address  Kailash, KTN 168A, Kothakulangara Temple road, Angamaly
Department of Cardiology, Preventive Cardiology, Room number 6, Amrita Institute of Medical Sciences, Ponnekkara PO
Ernakulam
KERALA
683572
India 
Phone  9895122099  
Fax    
Email  menon7jc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jaideep C Menon 
Designation  Professor , Adult Cardiology and Public health 
Affiliation  Amrita Institute of Medical Sciences 
Address  Kailash, KTN 168A, Kothakulangara Temple road, Angamaly
Department of Cardiology, Preventive Cardiology, Room number 6, Amrita Institute of Medical Sciences, Ponnekkara PO
Ernakulam
KERALA
683572
India 
Phone  9895122099  
Fax    
Email  menon7jc@gmail.com  
 
Source of Monetary or Material Support  
Amrita Institute of Medical Sciences, ICMR RMRC Bhubaneshwar 
 
Primary Sponsor  
Name  AIMS Kochi 
Address  Amrita Institute of Medical Sciences Ponnekkara, Ernakulam, Kerala 
Type of Sponsor  Private medical college 
 
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 Jaideep C Menon  Amrita Institute of Medical Sciences,   Department of Cardiology, Preventive Cardiology, Room number 6, Amrita Institute of Medical Sciences, Ponnekkara, Edapally PO Ernakulam 682041
Ernakulam
KERALA 
9895122099

menon7jc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Amrita School of Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lifestyle toolkit  The intervention comprises a lifestyle toolkit designed to address multiple facets of health, including guidance on diet and nutrition, tobacco and alcohol cessation, stress management, physical activity, and drug adherence. This toolkit is meticulously developed based on the WHO-HEARTS framework, with thoughtful regional contextualization. Implementation of the lifestyle toolkit is facilitated through community health volunteers and an M-health platform. And the duration of the intervention will be for 18 months.  
Comparator Agent  Standard of Care SoC  Enhanced standard of care with follow up from the treating physician 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Individuals diagnosed with Cardiometabolic Multimorbidity (CMM), defined as the concurrent presence of two or more of the following conditions: diabetes mellitus, stroke, or heart disease.
Identified individuals with CMM from the cohorts at Ernakulam, Tigiria and Sheragada 
 
ExclusionCriteria 
Details  Individuals with cognitive impairment impeding their ability to follow instructions.
Bedridden individuals.
Individuals with other significant confounding health conditions, such as malignancy or chronic airway disease.
Individuals aged 75 years or older.
Individuals diagnosed with a terminal medical condition.
Pregnant or lactating mothers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Outcomes- Change in glycaemic control (HbA1c)
Secondary outcomes – Change in systolic and diastolic blood pressure, BMI, Quality of life (QoL) scores, diet & nutrition patterns, stress levels, tobacco and alcohol usage, adherence to drugs and physical activity.
 
1st March 2024 to 28th February 2026 
 
Secondary Outcome  
Outcome  TimePoints 
econdary outcomes – Change in systolic and diastolic blood pressure, BMI, Quality of life (QoL) scores, diet & nutrition patterns, stress levels, tobacco and alcohol usage, adherence to drugs and physical activity.
 
1st March 2024 to 28th February 2026 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   18/09/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Lifestyle modification, including dietary interventions, physical activity, and stress management, has proven crucial in the non-pharmacological management of cardiometabolic risk factors. However, the efficacy of these interventions in the context of cardiometabolic multimorbidity (CMM) within the unique demographic and cultural milieu of India is inadequately explored, despite Indians exhibiting distinct susceptibility to cardiovascular diseases. This study aims to address existing knowledge gaps by assessing the effectiveness of a culturally tailored lifestyle toolkit based on the WHO-HEARTS framework in improving health outcomes among individuals with CMM and exploring the intergenerational preventive dimension. The study adopts a two-arm non-blinded Cluster Randomised Controlled Trial design to include adults diagnosed with CMM, defined by the presence of diabetes mellitus, stroke, or heart disease, aged 18 years and above, providing informed consent, and agreeing to follow-up. The trial spans three cohorts in Ernakulam (Kerala), Tigiria (Odisha), and Sheragada (Odisha), encompassing a total population of 330,055. The intervention, a ’lifestyle toolkit,’ integrates guidance on diet, physical activity, stress management, tobacco and alcohol cessation, and drug adherence. It leverages community health volunteers and an M-health platform for implementation. The comparator is Standard of Care (SoC), involving patient-initiated physician visits. Primary outcomes include changes in glycaemic control (HbA1c), while secondary outcomes encompass changes in blood pressure, body mass index, quality of life scores, diet patterns, stress levels, tobacco and alcohol usage, drug adherence, and physical activity. Measurements involve point-of-care devices and digital tools. The study duration is 36 months, with a sample size of 2000 participants distributed across 40 clusters. Statistical analysis includes repeated-measures ANOVA and multilevel models, employing an intention-to-treat approach. The study’s novelty lies in its holistic approach, addressing various facets of CMM comprehensively.

 
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