Xiangya School of Nursing, Central South University, Changsha, Hunan, People's Republic of China.
Philip R. Lee Institute for Health Policy Studies and Department of Family and Community Medicine, University of California, San Francisco, CA, USA.
BMC Public Health. 2018 Jun 28;18(1):809. doi: 10.1186/s12889-018-5725-x.
In China, about 53.4 million women (11%) have type 2 diabetes (T2DM). Women with prior 2 (GDM) are at a high risk for T2DM. Postpartum lifestyle interventions have been effective in reducing T2DM for this population, but the evidence is limited to interventions provided in urban areas, despite the fact that a higher prevalence of undiagnosed T2DM was found in rural areas in China. The primary purpose of this proposed study is to examine the effect of a postpartum intensive lifestyle modification (ILSM) program on physiological health outcomes (T2DM development, insulin resistance, and weight-related variables), weight-related health behaviors (dietary intake and physical activity), and psychosocial outcomes (self-efficacy, perceived stress, social support, and health-related quality of life) compared to usual care at 3, 6, and 18 months post baseline assessment. The secondary outcomes are to identify potential mediators and moderators on change of physiological health outcomes.
METHODS/DESIGN: A multi-site randomized clinical trial (RCT) will be conducted to examine the efficacy of an evidence-based Intensive Lifestyle Modification (ILSM) program compared with usual care for women with prior GDM living in rural areas in China. A total sample of 256 participants will be recruited in the study. The intervention consists of six bi-weekly in-person group sessions, five bi-weekly telephone consultation sessions, and three monthly telephone consultations to encourage behavior change. The usual care provided to the control group will utilize current clinical guideline and recommendations for T2DM prevention. Outcome measures include physiological variables (OGTT-2 h, HbA1c, weight, and waist circumference); weight-related health behavioral (dietary intake and physical activities); and psychosocial variables (self-efficacy and social support) at 3-, 6- and 18- month after baseline. We will also assess the potential cost-effectiveness of ILSM (net cost per T2DM case and per DALY averted) compared with usual care.
If successful, this ILSM program can be adapted and used in rural areas as a blueprint for clinical guidelines to decrease T2DM by improving postpartum GDM care in China. Findings of this study are expected to make a significant contribution to public health practice and health policy related to T2DM prevention in China.
Chinese Clinical Trial Registry, ChiCTR1800015023 . Registered 1 March 2018 - Retrospectively registered, http://apps.who.int/trialsearch/default.aspx .
在中国，约有 5340 万女性（11%）患有 2 型糖尿病（T2DM）。有既往妊娠糖尿病（GDM）史的女性患 T2DM 的风险很高。产后生活方式干预已被证明可有效降低该人群的 T2DM 风险，但证据仅限于城市地区提供的干预措施，尽管中国农村地区未确诊的 T2DM 患病率更高。本研究旨在比较产后强化生活方式干预（ILSM）方案与常规护理在 3、6 和 18 个月时对生理健康结局（T2DM 发展、胰岛素抵抗和体重相关变量）、体重相关健康行为（饮食摄入和身体活动）和心理社会结局（自我效能、感知压力、社会支持和健康相关生活质量）的影响。次要结局是确定生理健康结局变化的潜在中介和调节因素。
方法/设计：将开展一项多中心随机临床试验（RCT），以检验基于证据的强化生活方式干预（ILSM）方案与中国农村地区有既往 GDM 史的女性的常规护理相比的疗效。研究将招募 256 名参与者。干预措施包括 6 次每两周一次的面对面小组会议、5 次每两周一次的电话咨询会议和 3 次每月一次的电话咨询，以鼓励行为改变。对照组接受的常规护理将利用当前的临床指南和 T2DM 预防建议。主要结局包括生理变量（OGTT-2 h、HbA1c、体重和腰围）；体重相关健康行为（饮食摄入和身体活动）；以及心理社会变量（自我效能和社会支持），在基线后 3、6 和 18 个月进行评估。我们还将评估与常规护理相比，ILSM 的潜在成本效益（每例 T2DM 病例的净成本和每例避免的残疾调整生命年）。
如果成功，该 ILSM 方案可在农村地区进行调整和应用，作为改善中国产后 GDM 护理以减少 T2DM 的临床指南蓝本。本研究结果有望为中国 T2DM 预防的公共卫生实践和卫生政策做出重大贡献。
中国临床试验注册中心，ChiCTR1800015023。注册日期：2018 年 3 月 1 日。回顾性注册，http://apps.who.int/trialsearch/default.aspx。
