Background: Previous type 2 diabetes (T2DM) prevention programs, have been successful in reducing T2DM incidence up to 58%. However, programs have been intensive and costly. The aim was to evaluate the efficacy of a self-administered, gender-tailored, PULSE (Prevention Using LifeStyle Education) T2DM prevention program for men only.
Methods: A 6-month assessor-blinded, randomised controlled trial. Eligible men were 18-65 years, BMI 25-40 kg.m-2 and at high-risk for T2DM (Australian T2DM Risk Assessment Tool). After baseline assessment, men were randomised to intervention (n=53) or wait-list control (n=48) groups. PULSE included print and video resources on weight loss (SHED-IT Weight Loss Program), evidence-based diet for T2DM prevention and a home-based unsupervised aerobic and resistance training exercise program. The wait-list control group received no intervention for six months. Six-month outcome measures included weight, HbA1C, aerobic fitness, muscular fitness, food and nutrient intakes (Australian Eating Survey) and diet quality (Australian Recommended Food Score (ARFS). Generalised linear mixed models (intention-to-treat) evaluated group-by-time interactions.
Results: At baseline (mean ± SD) men were 52.3 ± 9.7 years, 103.0 ± 13.1 kg and HbA1C 5.8 ± 0.5%. Group-by-time differences at six months (mean [95% CI]) favoured the intervention for weight (-5.50 kg [-7.40, -3.61], P<0.001), HbA1C (-0.2% [-0.3, -0.1), P=0.002), diet quality (ARFS 4.4 [1.5, 7.4], P=0.004), % total energy (E%) from healthy core foods (7.6%[3.8, 11.3], P<0.001), E% fruit (2.3%[0.4, 4.3], P=0.020) fitness (estimated VO2max 3.43 mL.kg-1.min-1 [0.73, 6.13], P=0.013), muscular fitness (17 repetitions [9, 25], P<0.001) compared to controls. Total energy intake (-1285 kJ.day-1 [-2734, 165], P=0.08) and E% vegetables (0.8%[-0.9, 2.6], P=0.35) did not differ between groups despite significant intervention group improvements.
Discussion: This study demonstrates efficacy of a self-administered, gender-tailored lifestyle intervention on reducing T2DM risk factors in men. Future research should evaluate cost-effectiveness in community settings.