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

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• 作者：Elroy J. Aguiar ; PhD¹ ; ² ; ^{elroy.aguiar@uon.edu.au" class="auth_mail" title="E-mail the corresponding author} ; Philip J. Morgan ; PhD¹ ; ³ ; Clare E. Collins ; PhD¹ ; ⁴ ; Ronald C. Plotnikoff ; PhD¹ ; ³ ; Myles D. Young ; PhD¹ ; ³ ; Robin Callister ; PhD¹ ; ²
• 刊名：American Journal of Preventive Medicine
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：50
• 期：3
• 页码：353-364
• 全文大小：468 K

文摘

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 and >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<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.