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Testing a Lifestyle Toolkit to Improve Health for People with Multiple Health Problems Related to Heart and Metabolism

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092529
Enrollment
2000
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I259- Chronic ischemic heart disease, unspecified

Interventions

Intervention1: 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,

Sponsors

AIMS Kochi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. Timepoint: 1st March 2024 to 28th February 2026

Secondary

MeasureTime frame
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. Timepoint: 1st March 2024 to 28th February 2026

Countries

India

Contacts

Public ContactJaideep C Menon

Amrita Institute of Medical Sciences

menon7jc@gmail.com9895122099

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 4, 2026