| 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
|
|
|
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
|
|
|
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. |