title: Food for thought: pilot randomized controlled trial of lay health trainers supporting dietary change to reduce cardiovascular disease in deprived communities.
abstract: BACKGROUND
  Cardiovascular disease (CVD) accounts for 30% of UK deaths. It is associated with modifiable lifestyle factors, including insufficient consumption of fruit and vegetables (F&V). Lay health trainers (LHTs) offer practical support to help people develop healthier behaviour and lifestyles. Our two-group pilot randomized controlled trial (RCT) investigated the effectiveness of LHTs at promoting a heart-healthy lifestyle among adults with at least one risk factor for CVD to inform a full-scale RCT.
  
  
  METHODS
  Eligible adults (aged 21-78 years), recruited from five practices serving deprived populations, were randomized to health information leaflets plus LHTs' support for 3 months (n = 76) versus health information leaflets alone (n = 38).
  
  
  RESULTS
  We recruited 114 participants, with 60% completing 6 month follow-up. Both groups increased their self-reported F&V consumption and we found no evidence for LHTs' support having significant added impact. Most participants were relatively less deprived, as were the LHTs we were able to recruit and train.
  
  
  CONCLUSIONS
  Our pilot demonstrated that an LHT's RCT whilst feasible faces considerable challenges. However, to justify growing investment in LHTs, any behaviour changes and sustained impact on those at greatest need should be demonstrated in an independently evaluated, robust, fully powered RCT.
authors.affiliation: Department of Health Services Research, University of Liverpool, Liverpool L69 3GL, UK.
authors.forename: M
authors.initials: M
authors.lastname: Goodall
authors.affiliation: Health Economics Group, University of East Anglia, Norwich NR4 7TJ, UK.
authors.forename: G R
authors.initials: GR
authors.lastname: Barton
authors.affiliation: Centre for Primary Care, University of Manchester, Manchester M13 9PL, UK.
authors.forename: P
authors.initials: P
authors.lastname: Bower
authors.affiliation: Department of Health Services Research, University of Liverpool, Liverpool L69 3GL, UK.
authors.forename: P
authors.initials: P
authors.lastname: Byrne
authors.affiliation: School of Food Science and Nutrition, University of Leeds, Leeds LS2 9JT, UK.
authors.forename: J E
authors.initials: JE
authors.lastname: Cade
authors.affiliation: Department of Public Health ND Policy, University of Liverpool, Liverpool L69 3GB, UK.
authors.forename: S
authors.initials: S
authors.lastname: Capewell
authors.affiliation: School of Food Science and Nutrition, University of Leeds, Leeds LS2 9JT, UK.
authors.forename: C L
authors.initials: CL
authors.lastname: Cleghorn
authors.affiliation: Department of Clinical Sciences and Nutrition, University of Chester, Parkgate Road, Chester, CH1 4BJ, UK.
authors.forename: L A
authors.initials: LA
authors.lastname: Kennedy
authors.affiliation: Department of Health Services Research, University of Liverpool, Liverpool L69 3GL, UK.
authors.forename: A M
authors.initials: AM
authors.lastname: Martindale
authors.affiliation: Health Sciences Research Group, University of Manchester, Manchester M13 9PL, UK.
authors.forename: C
authors.initials: C
authors.lastname: Roberts
authors.affiliation: Department of Health Services Research, University of Liverpool, Liverpool L69 3GL, UK.
authors.forename: S
authors.initials: S
authors.lastname: Woolf
authors.affiliation: Department of Health Services Research, University of Liverpool, Liverpool L69 3GL, UK.
authors.forename: M B
authors.initials: MB
authors.lastname: Gabbay
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D003467:Cultural Deprivation; D004032:Diet; D004739:England; D005247:Feeding Behavior; D005260:Female; D005638:Fruit; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006282:Health Personnel; D006304:Health Status; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D018673:Nutrition Policy; D010865:Pilot Projects; D011320:Primary Health Care; D012307:Risk Factors; D014675:Vegetables; D055815:Young Adult
keywords: CVD; behaviour change; cardiovascular disease; lay health trainer; life style; primary health care