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首页> 外文期刊>Diabetic medicine: A journal of the British Diabetic Association >A lifestyle intervention programme for the prevention of Type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus [LIVING study]: protocol for a randomized trial
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A lifestyle intervention programme for the prevention of Type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus [LIVING study]: protocol for a randomized trial

机译：预防胎儿糖尿病南亚女性2型糖尿病患者的生活方式干预计划MELLITUS [生活研究]：随机试验的议定书

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Aim This study aims to determine whether a resource- and culturally appropriate lifestyle intervention programme in South Asian countries, provided to women with gestational diabetes (GDM) after childbirth, will reduce the incidence of worsening of glycaemic status in a manner that is affordable, acceptable and scalable. Methods Women with GDM (diagnosed by oral glucose tolerance test using the International Association of the Diabetes and Pregnancy Study Groups criteria) will be recruited from 16 hospitals in India, Sri Lanka and Bangladesh. Participants will undergo a repeat oral glucose tolerance test at 6 +/- 3 months postpartum and those without Type 2 diabetes, a total sample size of 1414, will be randomly allocated to the intervention or usual care. The intervention will consist of four group sessions, 84 SMS or voice messages and review phone calls over the first year. Participants requiring intensification of the intervention will receive two additional individual sessions over the latter half of the first year. Median follow-up will be 2 years. The primary outcome is the proportion of women with a change in glycaemic category, using the American Diabetes Association criteria: (i) normal glucose tolerance to impaired fasting glucose, or impaired glucose tolerance, or Type 2 diabetes; or (ii) impaired fasting glucose or impaired glucose tolerance to Type 2 diabetes. Process evaluation will explore barriers and facilitators of implementation of the intervention in each local context, while trial-based and modelled economic evaluations will assess cost-effectiveness. Discussion The study will generate important new evidence about a potential strategy to address the long-term sequelae of GDM, a major and growing problem among women in South Asia. (Clinical Trials Registry of India No: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry No: SLCTR/2017/001; and ClinicalTrials.gov Identifier No: NCT03305939)
机译：目的本研究旨在确定南亚国家的资源和文化适当的生活方式干预计划，为分娩后的妊娠糖尿病（GDM）提供给妇女，将以经济实惠的方式降低血糖地位恶化的发生率和可扩展。方法患有GDM的女性（使用国际糖尿病和怀孕研究组的国际协会诊断，诊断使用糖尿病和怀孕研究组标准）将从印度，斯里兰卡和孟加拉国的16家医院招募。参与者将在产后6 +/- 3个月内进行重复口服葡萄糖耐量测试，并且没有2型糖尿病的人，总样本大小为1414，将随机分配给干预或通常的护理。干预将包括四个组会议，84个短信或语音信息，并在第一年审核电话。需要加强干预的参与者将在第一年后半部分收到两项额外的个别课程。中位的后续行动将是2年。主要结果是使用美国糖尿病关联标准的血糖类别发生变化的妇女的比例：（i）常规葡萄糖耐受性损害空腹葡萄糖，或葡萄糖耐受性受损，或2型糖尿病;或（ii）禁止空腹葡萄糖或葡萄糖耐受性对2型糖尿病。过程评估将探讨每个地方背景下实施干预的障碍和促进者，而初审和建模的经济评估将评估成本效益。讨论该研究将产生关于解决GDM长期后遗症的潜在战略的重要新证据，南亚妇女的妇女长期后遗症。 （印度临床试验No：CTRI / 2017/06 / 008744;斯里兰卡临床试验登记号：SLCTR / 2017/001;和CLINCOLTRIANS.GOV标识符NO：NCT03305939）

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    Gupta Y.; Kapoor D.; Josyula L. K.; Praveen D.; Naheed A.; Desai A. K.; Pathmeswaran A.; de Silva H. A.; Lombard C. B.; Alam D. Shamsul; Prabhakaran D.; Teede H. J.; Billot L.; Bhatla N.; Joshi R.; Zoungas S.; Jan S.; Patel A.; Tandon N.;

  • 作者单位

    All India Inst Med Sci Dept Endocrinol &

    Metab New Delhi India;

    All India Inst Med Sci Dept Endocrinol &

    Metab New Delhi India;

    George Inst Global Hlth Hyderabad India;

    George Inst Global Hlth Hyderabad India;

    Icddr Hlth Syst &

    Populat Studies Div Initiat Noncommunicable Dis Dhaka Bangladesh;

    Goa Med Coll &

    Hosp Dept Med Bambolim Goa India;

    Univ Kelaniya Fac Med Dept Publ Hlth Ragama Sri Lanka;

    Univ Kelaniya Fac Med Dept Pharmacol Ragama Sri Lanka;

    Monash Univ Nutr &

    Dietet Melbourne Vic Australia;

    York Univ Sch Kinesiol &

    Hlth Sci Fac Hlth Toronto ON Canada;

    Ctr Chron Dis Control Gurugram India;

    Monash Univ Sch Publ Hlth &

    Prevent Med Monash Ctr Hlth Res &

    Implementat Melbourne Vic;

    Univ New South Wales George Inst Global Hlth Sydney NSW Australia;

    All India Inst Med Sci Dept Obstet &

    Gynaecol New Delhi India;

    Univ New South Wales George Inst Global Hlth Sydney NSW Australia;

    Monash Univ Sch Publ Hlth &

    Prevent Med Div Metab Ageing &

    Genom Melbourne Vic Australia;

    Univ New South Wales George Inst Global Hlth Sydney NSW Australia;

    Univ New South Wales George Inst Global Hlth Sydney NSW Australia;

    All India Inst Med Sci Dept Endocrinol &

    Metab New Delhi India;

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  • 正文语种 eng
  • 中图分类 内分泌腺疾病及代谢病;
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