title: Waste the waist: a pilot randomised controlled trial of a primary care based intervention to support lifestyle change in people with high cardiovascular risk.
abstract: BACKGROUND
  In the UK, thousands of people with high cardiovascular risk are being identified by a national risk-assessment programme (NHS Health Checks). Waste the Waist is an evidence-informed, theory-driven (modified Health Action Process Approach), group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk. This pilot randomised controlled trial aimed to assess the feasibility of delivering the Waste the Waist intervention in UK primary care and of conducting a full-scale randomised controlled trial. We also conducted exploratory analyses of changes in weight.
  
  
  METHODS
  Patients aged 40-74 with a Body Mass Index of 28 or more and high cardiovascular risk were identified from risk-assessment data or from practice database searches. Participants were randomised, using an online computerised randomisation algorithm, to receive usual care and standardised information on cardiovascular risk and lifestyle (Controls) or nine sessions of the Waste the Waist programme (Intervention). Group allocation was concealed until the point of randomisation. Thereafter, the statistician, but not participants or data collectors were blinded to group allocation. Weight, physical activity (accelerometry) and cardiovascular risk markers (blood tests) were measured at 0, 4 and 12 months.
  
  
  RESULTS
  108 participants (22% of those approached) were recruited (55 intervention, 53 controls) from 6 practices and 89% provided data at both 4 and 12 months. Participants had a mean age of 65 and 70% were male. Intervention participants attended 72% of group sessions. Based on last observations carried forward, the intervention group did not lose significantly more weight than controls at 12 months, although the difference was significant when co-interventions and co-morbidities that could affect weight were taken into account (Mean Diff 2.6Kg. 95%CI: -4.8 to -0.3, p = 0.025). No significant differences were found in physical activity.
  
  
  CONCLUSIONS
  The Waste the Waist intervention is deliverable in UK primary care, has acceptable recruitment and retention rates and produces promising preliminary weight loss results. Subject to refinement of the physical activity component, it is now ready for evaluation in a full-scale trial.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN10707899 .
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Magdalen Road, Exeter, EX1 2LU, UK. c.j.greaves@exeter.ac.uk.
authors.forename: Colin
authors.initials: C
authors.lastname: Greaves
authors.affiliation: University of Bath, Claverton Down, Bath, BA2 7AY, UK. f.b.gillison@bath.ac.uk.
authors.forename: Fiona
authors.initials: F
authors.lastname: Gillison
authors.affiliation: University of Bath, Claverton Down, Bath, BA2 7AY, UK. as391@bath.ac.uk.
authors.forename: Afroditi
authors.initials: A
authors.lastname: Stathi
authors.affiliation: University of Bath, Claverton Down, Bath, BA2 7AY, UK. p.bennett@bath.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: Bennett
authors.affiliation: School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia. Prasuna.Reddy@newcastle.edu.au.
authors.forename: Prasuna
authors.initials: P
authors.lastname: Reddy
authors.affiliation: Greater Green Triangle University Department of Rural Health, Flinders and Deakin Universities, PO Box 423, Warrnambool, VIC, 3280, Australia. Director@greaterhealth.org.
authors.forename: James
authors.initials: J
authors.lastname: Dunbar
authors.affiliation: University of Bath, Claverton Down, Bath, BA2 7AY, UK. Rachel.Perry@bristol.ac.uk.
authors.forename: Rachel
authors.initials: R
authors.lastname: Perry
authors.affiliation: Bath, Gloucester, Swindon, Wiltshire Area Public Health Team, Public Health England, 1st Floor Bewley House, Marshfield Road, Chippenham, Wiltshire, SN15 1JW, UK. daniel.messom@nhs.net.
authors.forename: Daniel
authors.initials: D
authors.lastname: Messom
authors.affiliation: Waste the Waist Service User Advisory Group, c/o Colin Greaves, University of Exeter Medical School, St Luke's Campus, Magdalen Road, Exeter, EX1 2PU, UK. roger.chandler@gmail.com.
authors.forename: Roger
authors.initials: R
authors.lastname: Chandler
authors.affiliation: Waste the Waist Service User Advisory Group, c/o Colin Greaves, University of Exeter Medical School, St Luke's Campus, Magdalen Road, Exeter, EX1 2PU, UK. margarettusker@tiscali.co.uk.
authors.forename: Margaret
authors.initials: M
authors.lastname: Francis
authors.affiliation: Centre for Exercise, Nutrition and Health Sciences, University of Bristol, 8 Priory Road, Bristol, BS8 1TZ, UK. mark.davis.ac.uk@gmail.com.
authors.forename: Mark
authors.initials: M
authors.lastname: Davis
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Magdalen Road, Exeter, EX1 2LU, UK. c.green@exeter.ac.uk.
authors.forename: Colin
authors.initials: C
authors.lastname: Green
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Magdalen Road, Exeter, EX1 2LU, UK. P.H.Evans@exeter.ac.uk.
authors.forename: Philip
authors.initials: P
authors.lastname: Evans
authors.affiliation: University of Bath, Claverton Down, Bath, BA2 7AY, UK. g.j.taylor@bath.ac.uk.
authors.forename: Gordon
authors.initials: G
authors.lastname: Taylor
mesh_terms: D000368:Aged; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control*; D004032:Diet; D015444:Exercise; D005240:Feasibility Studies; D005260:Female; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000628:therapy; D010865:Pilot Projects; D011320:Primary Health Care; D015397:Program Evaluation; D012307:Risk Factors; D006113:United Kingdom