Greater Green Triangle University Department of Rural Health, Flinders University and Deakin University, PO Box 423, Warrnambool, VIC 3280, Australia.
Trials. 2012 Aug 28;13:152. doi: 10.1186/1745-6215-13-152.
The successful Greater Green Triangle Diabetes Prevention Program (GGT DPP), a small implementation trial, has been scaled-up to the Victorian state-wide 'Life!' programme with over 10,000 individuals enrolled. The Melbourne Diabetes Prevention Study (MDPS) is an evaluation of the translation from the GGT DPP to the Life! programme. We report results from the preliminary phase (pMDPS) of this evaluation.
The pMDPS is a randomised controlled trial with 92 individuals aged 50 to 75 at high risk of developing type 2 diabetes randomised to Life! or usual care. Intervention consisted of six structured 90-minute group sessions: five fortnightly sessions and the final session at 8 months. Participants underwent anthropometric and laboratory tests at baseline and 12 months, and provided self-reported psychosocial, dietary, and physical activity measures. Intervention group participants additionally underwent these tests at 3 months. Paired t tests were used to analyse within-group changes over time. Chi-square tests were used to analyse differences between groups in goals met at 12 months. Differences between groups for changes over time were tested with generalised estimating equations and analysis of covariance.
Intervention participants significantly improved at 12 months in mean body mass index (-0.98 kg/m(2), standard error (SE) = 0.26), weight (-2.65 kg, SE = 0.72), waist circumference (-7.45 cm, SE = 1.15), and systolic blood pressure (-3.18 mmHg, SE = 1.26), increased high-density lipoprotein-cholesterol (0.07 mmol/l, SE = 0.03), reduced energy from total (-2.00%, SE = 0.78) and saturated fat (-1.54%, SE = 0.41), and increased fibre intake (1.98 g/1,000 kcal energy, SE = 0.47). In controls, oral glucose at 2 hours deteriorated (0.59 mmol/l, SE = 0.27). Only waist circumference reduced significantly (-4.02 cm, SE = 0.95).Intervention participants significantly outperformed controls over 12 months for body mass index and fibre intake. After baseline adjustment, they also showed greater weight loss and reduced saturated fat versus total energy intake.At least 5% weight loss was achieved by 32% of intervention participants versus 0% controls.
pMDPS results indicate that scaling-up from implementation trial to state-wide programme is possible. The system design for Life! was fit for purpose of scaling-up from efficacy to effectiveness.
Australian and New Zealand Clinical Trials Registry ACTRN12609000507280.
成功的大绿三角糖尿病预防计划（GGT DPP）是一项小规模的实施试验，现已扩大到维多利亚州范围广泛的“生活！”计划，已有超过 10000 人参加。墨尔本糖尿病预防研究（MDPS）是对 GGT DPP 向 Life！计划的翻译进行的评估。我们报告了该评估初步阶段（pMDPS）的结果。
pMDPS 是一项随机对照试验，92 名年龄在 50 至 75 岁之间的高危 2 型糖尿病患者被随机分配到 Life！或常规护理组。干预措施包括六次结构化的 90 分钟小组会议：五次每两周一次，最后一次在 8 个月时进行。参与者在基线和 12 个月时接受了人体测量和实验室测试，并提供了自我报告的社会心理、饮食和身体活动测量值。干预组的参与者还在 3 个月时接受了这些测试。配对 t 检验用于分析随时间的组内变化。卡方检验用于分析 12 个月时目标达成情况的组间差异。使用广义估计方程和协方差分析检验组间随时间的变化差异。
干预组在 12 个月时的平均体重指数（-0.98kg/m2，标准误差（SE）=0.26）、体重（-2.65kg，SE=0.72）、腰围（-7.45cm，SE=1.15）和收缩压（-3.18mmHg，SE=1.26）显著改善，高密度脂蛋白胆固醇（0.07mmol/L，SE=0.03）增加，总能量（-2.00%，SE=0.78）和饱和脂肪（-1.54%，SE=0.41）减少，膳食纤维摄入量（1.98g/1000kcal 能量，SE=0.47）增加。对照组 2 小时口服葡萄糖恶化（0.59mmol/L，SE=0.27）。只有腰围显著缩小（-4.02cm，SE=0.95）。干预组在 12 个月时的体重指数和膳食纤维摄入量明显优于对照组。在基线调整后，他们还显示出更大的体重减轻和减少的饱和脂肪与总能量摄入的比例。至少 5%的体重减轻在 32%的干预组中实现，而对照组为 0%。
pMDPS 的结果表明，从实施试验扩大到全州范围的计划是可行的。Life！的系统设计适合从疗效扩大到效果。
澳大利亚和新西兰临床试验注册 ACTRN12609000507280。
