title: 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.
abstract: Recognizing patterns of coronary heart disease (CHD) risk in families helps to identify and target individuals who may have the most to gain from preventive interventions. The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in high risk families. The proposed care model targets the structural and environmental conditions that predispose high risk families to development of CHD through the following interventions: 1) screening for cardiovascular risk factors, 2) providing lifestyle interventions 3) providing a framework for linkage to appropriate primary health care facility, and 4) active follow-up of intervention adherence.
  
  
  
  Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package and feedback on the intervention. Then a cluster randomized controlled trial involving 740 families comprising 1480 participants will be conducted to determine whether the package of interventions (integrated care model) is effective in reducing or preventing the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic (cost-effectiveness analyses) and qualitative evaluation (process outcomes) to estimate value and acceptability. Scalability is informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.
  
  
  
  Knowledge generated from this trial has the potential to significantly affect new programmatic policy and clinical guidelines that will lead to improvements in cardiovascular health in India.
  
  
  
  NCT02771873, registered in May 2016 ( https://clinicaltrials.gov/ct2/show/results/NCT02771873 ).
authors.affiliation: Public Health Foundation of India, New Delhi, India. jeemon.p@phfi.org.
authors.forename: Panniyammakal
authors.identifier: 0000-0003-4172-4307
authors.initials: P
authors.lastname: Jeemon
authors.affiliation: Sree Chitra Tirunal Institute of Medical Sciences and Technology, Trivandrum, India.
authors.forename: S
authors.initials: S
authors.lastname: Harikrishnan
authors.affiliation: Sree Chitra Tirunal Institute of Medical Sciences and Technology, Trivandrum, India.
authors.forename: G
authors.initials: G
authors.lastname: Sanjay
authors.affiliation: Sree Chitra Tirunal Institute of Medical Sciences and Technology, Trivandrum, India.
authors.forename: Sivasankaran
authors.initials: S
authors.lastname: Sivasubramonian
authors.affiliation: Public Health Foundation of India, New Delhi, India.
authors.forename: T R
authors.initials: TR
authors.lastname: Lekha
authors.affiliation: Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
authors.forename: Sandosh
authors.initials: S
authors.lastname: Padmanabhan
authors.affiliation: All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Nikhil
authors.initials: N
authors.lastname: Tandon
authors.affiliation: Public Health Foundation of India, New Delhi, India.
authors.forename: Dorairaj
authors.initials: D
authors.lastname: Prabhakaran
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000235:genetics / Q000517:prevention & control*; D005190:Family; D005260:Female; D020022:Genetic Predisposition to Disease; D006801:Humans; D007194:India; D008019:Life Style; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D040242:Risk Reduction Behavior; D016896:Treatment Outcome; D055815:Young Adult