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Efficacy of the type 2 diabetes prevention using lifestyle education program RCT |
Aguiar EJ, Morgan PJ, Collins CE, Plotnikoff RC, Young MD, Callister R |
American Journal of Preventive Medicine 2016 Mar;50(3):353-364 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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 to 2013. PARTICIPANTS: Men (aged 18 to 65 years, BMI 25 to 40 kg/m2, high risk for developing type 2 diabetes mellitus) were stratified by age (< 50 and > 50 years) and BMI category (25.0 to 29.9, 30.0 to 35.9, and 35.0 to 40 kg/m2) 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 to 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 x 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 x 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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