title: Efficacy of the Type 2 Diabetes Prevention Using LifeStyle Education Program RCT.
abstract: BACKGROUND
  Self-administered lifestyle interventions have been suggested as an alternative to face-to-face delivery modes, although their efficacy remains uncertain. The aim of this study was to evaluate the efficacy of the Type 2 diabetes mellitus Prevention Using LifeStyle Education (PULSE) Program, a self-administered and gender-tailored lifestyle intervention for men at high risk for developing Type 2 diabetes mellitus.
  
  
  METHODS
  A 6-month, assessor-blinded, parallel-group RCT was conducted at the University of Newcastle, Australia in 2012-2013.
  
  
  METHODS
  Men (aged 18-65 years, BMI 25-40 kg/m(2), high risk for developing Type 2 diabetes mellitus) were stratified by age (<50 and >50 years) and BMI category (25.0-29.9, 30.0-35.9, and 35.0-40 kg/m(2)) and individually randomized (1:1 ratio) to the intervention (n=53) or waitlist control groups (n=48).
  
  
  METHODS
  The intervention group received the PULSE Program, which contained print and video resources on weight loss (Self-Help, Exercise and Diet using Internet Technology [SHED-IT] Weight Loss Program), diet modification, and exercise for Type 2 diabetes mellitus prevention. The waitlist control group received no information until 6 months.
  
  
  METHODS
  Data were collected from September 2012 to September 2013 and analyzed in 2014-2015. Linear mixed models (intention-to-treat) were used to determine group X time interactions (differences between groups in changes over time) at 6 months for the primary outcome (weight), glycated hemoglobin, and several secondary outcomes (significance level, p<0.05).
  
  
  RESULTS
  Differences between groups in mean changes from baseline to 6 months (group × time interaction) favored the intervention over control group for weight loss (-5.50 kg, 95% CI=-7.40 kg, -3.61 kg, p<0.001, Cohen's d=1.15), glycated hemoglobin (-0.2%, 95% CI=-0.3%, -0.1%, p=0.002, d=0.64), and BMI, waist circumference, body fat percentage, aerobic fitness, and lower body muscular fitness (all p<0.05). No group × time effects were observed for fasting plasma glucose, upper body muscular fitness, physical activity, or energy intake.
  
  
  CONCLUSIONS
  The PULSE Program improved several Type 2 diabetes mellitus risk factors in men, including weight and glycated hemoglobin. These findings provide evidence for a self-administered and gender-tailored lifestyle intervention, which has potential for dissemination in community settings.
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia. Electronic address: elroy.aguiar@uon.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, Callaghan, New South Wales, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Morgan
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Clare E
authors.initials: CE
authors.lastname: Collins
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Plotnikoff
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; School of Education, Faculty of Education and Arts, University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Myles D
authors.initials: MD
authors.lastname: Young
authors.affiliation: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, New South Wales, Australia; School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia.
authors.forename: Robin
authors.initials: R
authors.lastname: Callister
mesh_terms: D000328:Adult; D001315:Australia; D001786:Blood Glucose; D049628:Body Size; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D002149:Energy Intake; D015444:Exercise; D006442:Glycated Hemoglobin / Q000032:analysis; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008019:Life Style; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D012648:Self Care / Q000592:standards*; D061217:Weight Reduction Programs / Q000592:standards*
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin