Background/Aims: T2DM prevention programs have reduced incidence by up to 58%. However, programs have been intensive and costly. The aim was to evaluate efficacy of a self-administered, gender-tailored T2DM prevention PULSE (Prevention Using LifeStyle Education) 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 T2DM risk (Australian Risk Assessment Tool). 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 and a home-based unsupervised aerobic exercise and resistance training program. Six-month outcome measures included weight, HbA1C,, fitness, diet quality (Australian Recommended Food Score (ARFS) and food and nutrient intakes (Australian Eating Survey). 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 6- 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), % energy (E%) from core foods (7.6%[3.8, 11.3], P<0.001), E% fruit (2.3%[0.4, 4.3], P=0.020) 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.
Conclusions: 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.
Funding Source: Hunter Medical Research Institute