妊娠糖尿病(GDM)后患有葡萄糖耐受不良的女性患2型糖尿病的风险很高。传统的产后早期生活方式干预效果有限。我们调查了混合的基于移动的生活方式干预在最近的GDM病史后患有葡萄糖不耐受的女性中的疗效。
■预期,双臂,非蒙面,多中心随机对照试验(RCT),在GDM并发妊娠后6-16周诊断,被分配1:1进行为期一年的混合护理,基于电话和移动的生活方式计划(干预)或常规护理(控制)。主要终点是意向治疗样本中能够实现体重目标的女性比例(如果孕前BMI≥25kg/m2,则体重减轻≥5%,如果孕前BMI<25kg/m2,则恢复到孕前体重)。关键的次要结果是葡萄糖不耐受的频率,糖尿病和代谢综合征,和生活方式相关的结果通过自我管理问卷进行评估。该研究在ClinicalTrials.gov(NCT03559621)中注册。
■在2019年4月10日至2022年5月13日之间,240名参与者被分配到干预组(n=121)或对照组(n=119)。其中167人(干预组n=82,对照组n=85)完成了研究。46.3%(56)的干预参与者获得了主要结局,而对照组为43.3%(52)[比值比(OR)1.13,95%置信区间(CI)0.63-2.03,p=0.680;风险比1.07,95%CI(0.78-1.48)]。与对照组相比,干预组的女性患代谢综合征的频率明显较低[7.3%(6)与16.5%(14),或0.40,CI(0.22-0.72),p=0.002],报告的久坐行为较少,持续健康行为的动机较高。在干预组中,84.1%(69人)参加了至少8次电话会议,70.7%(58人)每周至少一次使用该应用程序。
■混合,基于移动的生活方式干预不能有效地实现体重目标,但降低了患代谢综合征的风险。
■鲁汶大学医院研究基金,诺和诺德,赛诺菲,阿斯利康,勃林格-英格尔海姆,莉莉
UNASSIGNED: Women with glucose intolerance after gestational diabetes mellitus (GDM) are at high risk to develop type 2 diabetes. Traditional lifestyle interventions in early postpartum have limited impact. We investigated the efficacy of a blended mobile-based lifestyle intervention in women with glucose intolerance after a recent history of GDM.
UNASSIGNED: Prospective, double-arm, non-masked, multicentre randomised controlled trial (RCT) in which women with glucose intolerance, diagnosed 6-16 weeks after a GDM-complicated pregnancy, were assigned 1:1 to a one-year blended-care, telephone- and mobile-based lifestyle program (intervention) or usual care (control). Primary endpoint was the proportion of women able to achieve their weight goal (≥5% weight loss if prepregnancy BMI ≥ 25 kg/m2 or return to prepregnancy weight if prepregnancy BMI < 25 kg/m2) in the intention-to-treat sample. Key secondary outcomes were frequency of glucose intolerance, diabetes and metabolic syndrome, and lifestyle-related outcomes assessed with self-administered questionnaires. The study was registered in ClinicalTrials.gov (NCT03559621).
UNASSIGNED: Between April 10th 2019 and May 13th 2022, 240 participants were assigned to the intervention (n = 121) or control group (n = 119), of which 167 (n = 82 in intervention and n = 85 in control group) completed the study. Primary outcome was achieved by 46.3% (56) of intervention participants compared to 43.3% (52) in the control group [odds ratio (OR) 1.13, 95% confidence interval (CI) 0.63-2.03, p = 0.680; risk ratio 1.07, 95% CI (0.78-1.48)]. Women in the intervention group developed significantly less often metabolic syndrome compared to the control group [7.3% (6) vs. 16.5% (14), OR 0.40, CI (0.22-0.72), p = 0.002], reported less sedentary behaviour and higher motivation for continuing healthy behaviours. In the intervention group, 84.1% (69) attended at least eight telephone sessions and 70.7% (58) used the app at least once weekly.
UNASSIGNED: A blended, mobile-based lifestyle intervention was not effective in achieving weight goals, but reduced the risk to develop metabolic syndrome.
UNASSIGNED: Research fund of University Hospitals Leuven, Novo Nordisk, Sanofi, AstraZeneca, Boehringer-Ingelheim, Lilly.