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

• Published in: American journal of preventive medicine 2016-03, Vol.50 (3), p.353-364
• Main Authors: Aguiar, Elroy J., PhD, Morgan, Philip J., PhD, Collins, Clare E., PhD, Plotnikoff, Ronald C., PhD, Young, Myles D., PhD, Callister, Robin, PhD
• Format: Article
• Language: English
• Subjects: Adult; Australia; Blood Glucose; Body Size; Diabetes Mellitus, Type 2 - prevention & control; Energy Intake; Exercise; Glycated Hemoglobin A - analysis; Health Behavior; Health Promotion - methods; Humans; Internal Medicine; Life Style; Linear Models; Male; Middle Aged; Self Care - standards; Weight Reduction Programs - standards
• ISSN: 0749-3797; 1873-2607
• DOI: 10.1016/j.amepre.2015.08.020

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/m2 , high risk for developing Type 2 diabetes mellitus) were stratified by age (50 years) and BMI category (25.0−29.9, 30.0−35.9, and 35.0−40 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 2014−2015. 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