Efficacy of the Type 2 Diabetes Prevention Using LifeStyle Education Program RCT

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.