NCT02771873

Brief Summary

The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in individuals with family history of premature coronary heart disease (CHD). This care model involves:

  1. 1.screening for cardiovascular risk factors,
  2. 2.providing lifestyle interventions for prevention and management of cardiovascular risk factors,
  3. 3.providing a framework for linkage to appropriate primary health care facility and
  4. 4.active follow-up of intervention adherence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,678

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2021

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

5.5 years

First QC Date

May 5, 2016

Last Update Submit

January 15, 2021

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Composite outcome of multiple cardiovascular risk factors

    Proportions achieving blood pressure\<140/90 mmHg, fasting blood glucose (FPG)\<110 mg/dl, low-density lipoprotein (LDL)\<100 mg/dl, and abstinence from smoking/tobacco use.

    2 year

Secondary Outcomes (5)

  • Blood pressure

    2 year

  • Blood lipids

    2 Year

  • Blood Glucose

    2 year

  • Behavioural factors

    2 Year

  • Acute Coronary Syndrome

    2 year

Study Arms (2)

Usual care

NO INTERVENTION

Screening for CVD risk factors plus one time education regarding management of risk factors will be provided to all family members.

Life style Intervention and care coordination

EXPERIMENTAL

Integrated cardiovascular disease risk management.

Behavioral: Integrated cardiovascular disease risk management.

Interventions

Integrated cardiovascular disease risk management.BEHAVIORAL

Health promotion intervention

Life style Intervention and care coordination

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 18 years of age.

You may not qualify if:

  • Bedridden and terminally ill patients. Those who are not willing to provide written informed consent will be also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sree Chitra Tirunal Institute for Medical Sciences and Technology

Trivandrum, Kerala, 695011, India

Location

Related Publications (5)

  • Jeemon P, Athira T, Lekha TR, Ismail S, Ganapathi S, Harikrishnan S. Family-based interventions for optimal blood pressure outcomes in adults: a cluster randomised controlled trial in India. J Hypertens. 2025 Nov 1;43(11):1871-1877. doi: 10.1097/HJH.0000000000004132. Epub 2025 Sep 3.

    PMID: 40990535DERIVED

  • John AS, Ganapathi S, Harikrishnan S, Lekha TR, Stanley A, Soman B, Anish TS, Hadaye R, Cherian JJ, Tandon N, Prabhakaran D, Jeemon P. Within-Trial Cost-Effectiveness Analysis of a Family-Based Structured Lifestyle Modification Intervention Program for Cardiovascular Risk Reduction: Results from the PROLIFIC Trial. Glob Heart. 2025 Jul 31;20(1):65. doi: 10.5334/gh.1450. eCollection 2025.

    PMID: 40757252DERIVED

  • Panniyammakal J, Stanley A, Ismail S, Lekha TR, Ganapathi S, Harikrishnan S. Family-Based Interventions to Promote Weight Management in Adults: Results From a Cluster Randomized Controlled Trial in India. Ann Fam Med. 2025 Mar 24;23(2):93-99. doi: 10.1370/afm.230632.

    PMID: 40127979DERIVED

  • Jeemon P, Harikrishnan S, Ganapathi S, Sivasankaran S, Binukumar B, Padmanabhan S, Tandon N, Prabhakaran D. Efficacy of a family-based cardiovascular risk reduction intervention in individuals with a family history of premature coronary heart disease in India (PROLIFIC): an open-label, single-centre, cluster randomised controlled trial. Lancet Glob Health. 2021 Oct;9(10):e1442-e1450. doi: 10.1016/S2214-109X(21)00319-3.

    PMID: 34534488DERIVED

  • Jeemon P, Harikrishnan S, Sanjay G, Sivasubramonian S, Lekha TR, Padmanabhan S, Tandon N, Prabhakaran D. A PROgramme of Lifestyle Intervention in Families for Cardiovascular risk reduction (PROLIFIC Study): design and rationale of a family based randomized controlled trial in individuals with family history of premature coronary heart disease. BMC Public Health. 2017 Jan 5;17(1):10. doi: 10.1186/s12889-016-3928-6.

    PMID: 28056897DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Panniyammakal Jeemon, Ph.D

    Public Health Foundation of India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 13, 2016

Study Start

July 1, 2015

Primary Completion

January 14, 2021

Study Completion

January 14, 2021

Last Updated

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)