Elroy J Aguiar1, Philip J Morgan2, Clare E Collins3, Ronald C Plotnikoff2, Myles D Young2, Robin Callister4. 1. 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. 2. 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. 3. 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. 4. 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.
Abstract
INTRODUCTION: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. DESIGN/ SETTING: A 6-month, assessor-blinded, parallel-group RCT was conducted at the University of Newcastle, Australia in 2012-2013. PARTICIPANTS: 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). INTERVENTION: 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. MAIN OUTCOME MEASURES: 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.
RCT Entities:
INTRODUCTION: 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. DESIGN/ SETTING: A 6-month, assessor-blinded, parallel-group RCT was conducted at the University of Newcastle, Australia in 2012-2013. PARTICIPANTS: 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). INTERVENTION: 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. MAIN OUTCOME MEASURES: 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.
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