Minschart Caro, Myngheer Nele, Maes Toon, De Block Christophe, Van Pottelbergh Inge, Abrams Pascale, Vinck Wouter, Leuridan Liesbeth, Driessens Sabien, Mathieu Chantal, Billen Jaak, Matthys Christophe, Laenen Annouschka, Bogaerts Annick, Benhalima Katrien
Department of Endocrinology, University Hospitals Leuven, Leuven 3000, Belgium.
Department of Endocrinology, General Hospital Groeninge, Kortrijk 8500, Belgium.
EClinicalMedicine. 2024 Mar 8;70:102523. doi: 10.1016/j.eclinm.2024.102523. eCollection 2024 Apr.
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.
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/m or return to prepregnancy weight if prepregnancy BMI < 25 kg/m) 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).
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.
A blended, mobile-based lifestyle intervention was not effective in achieving weight goals, but reduced the risk to develop metabolic syndrome.
Research fund of University Hospitals Leuven, Novo Nordisk, Sanofi, AstraZeneca, Boehringer-Ingelheim, Lilly.
妊娠期糖尿病（GDM）后出现糖耐量异常的女性患2型糖尿病的风险很高。产后早期的传统生活方式干预效果有限。我们调查了一种基于移动设备的综合生活方式干预对近期有GDM病史且糖耐量异常女性的疗效。
一项前瞻性、双臂、非盲、多中心随机对照试验（RCT），将妊娠合并GDM后6 - 16周诊断为糖耐量异常的女性按1:1分配到为期一年的综合护理、基于电话和移动设备的生活方式项目（干预组）或常规护理（对照组）。主要终点是在意向性治疗样本中能够实现体重目标的女性比例（如果孕前BMI≥25 kg/m²，则体重减轻≥5%；如果孕前BMI<25 kg/m²，则恢复到孕前体重）。关键次要结局是糖耐量异常、糖尿病和代谢综合征的发生频率，以及通过自我管理问卷评估的与生活方式相关的结局。该研究已在ClinicalTrials.gov注册（NCT03559621）。
在2019年4月10日至2022年5月13日期间，240名参与者被分配到干预组（n = 121）或对照组（n = 119），其中167名（干预组n = 82，对照组n = 85）完成了研究。干预组46.3%（56名）的参与者实现了主要结局，而对照组为43.3%（52名）[优势比（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，干预组女性发生代谢综合征的频率显著更低[7.3%（6名）对16.5%（14名），OR 0.40，CI（0.22 - 0.72），p = 0.002]，报告的久坐行为更少，且持续健康行为的动机更高。在干预组中，84.1%（69名）至少参加了八次电话会议，70.7%（58名）每周至少使用一次应用程序。
基于移动设备的综合生活方式干预在实现体重目标方面无效，但降低了发生代谢综合征的风险。
鲁汶大学医院研究基金、诺和诺德、赛诺菲、阿斯利康、勃林格殷格翰、礼来。
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