title: The PULSE (Prevention Using LifeStyle Education) trial protocol: a randomised controlled trial of a Type 2 Diabetes Prevention programme for men.
abstract: BACKGROUND
  Intensive lifestyle interventions have been successful in reducing type 2 diabetes incidence. Whether intensive programmes requiring face-to-face contact, trained staff and access to facilities are feasible, on a larger scale, has been debated.
  
  
  OBJECTIVE
  The aim of this study is to determine the feasibility and efficacy of a lifestyle intervention for type 2 diabetes prevention in men using an assessor-blinded, parallel-group, randomised controlled trial. The 'Type 2 Diabetes PULSE (Prevention Using LifeStyle Education) Programme for Men' is a 6-month, self-administered, gender-tailored lifestyle intervention, with a multicomponent approach (weight loss, dietary modification, aerobic exercise and resistance training). Eligible men were aged 18-65 years, overweight/obese (BMI 25-40 kg·m(-2)) and at high-risk for type 2 diabetes (score ≥ 12, Australian diabetes risk tool). Men with diagnosed prediabetes were eligible, but those with type 1 and 2 diabetes were ineligible. Randomisation was stratified by age (<50 or ≥ 50 years) and BMI category (kg·m(-2): 25-29.9; 30-34.9; 35-40) to the intervention or wait-list control group. Data are collected at study entry (baseline), 3 and 6 months. The primary outcome is weight change at 6 months. Secondary outcomes include: fasting plasma glucose, HbA1C, waist circumference, body composition, blood pressure, diet quality, aerobic fitness, muscular fitness and physical activity. Generalised linear mixed models (intention-to-treat) will assess outcomes for treatment (intervention vs. control), time (baseline, 3 and 6-months) and the treatment-by-time interaction.
  
  
  CONCLUSIONS
  The results will determine the efficacy of a type 2 diabetes prevention programme for men with potential for wide reach and dissemination.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry (ACTRN12612000721808).
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Elroy.Aguiar@newcastle.edu.au.
authors.forename: Elroy J
authors.initials: EJ
authors.lastname: Aguiar
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Philip.Morgan@newcastle.edu.au.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Morgan
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Clare.Collins@newcastle.edu.au.
authors.forename: Clare E
authors.initials: CE
authors.lastname: Collins
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Ron.Plotnikoff@newcastle.edu.au.
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Plotnikoff
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Myles.Young@newcastle.edu.au.
authors.forename: Myles D
authors.initials: MD
authors.lastname: Young
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia; School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, NSW 2308, Australia. Electronic address: Robin.Callister@newcastle.edu.au.
authors.forename: Robin
authors.initials: R
authors.lastname: Callister
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D001315:Australia; D001786:Blood Glucose; D015992:Body Mass Index; D001837:Body Weights and Measures; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D004032:Diet; D015444:Exercise; D006442:Glycated Hemoglobin; D015438:Health Behavior; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000628:therapy; D050177:Overweight / Q000628:therapy*; D011788:Quality of Life; D012307:Risk Factors; D016037:Single-Blind Method; D012959:Socioeconomic Factors; D061217:Weight Reduction Programs / Q000379:methods*; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin
keywords: Diet; Exercise; Prevention; Resistance training; Type 2 diabetes; Weight loss