A pilot lifestyle intervention for women with histories of GDM: The PEG Study

描述(由申请人提供)： 10%到50%患有妊娠期糖尿病(GDM)或在怀孕期间首次发现的葡萄糖不耐受的妇女，在分娩后5年内发展为2型糖尿病(2型DM)。虽然强化干预可以降低糖耐量受损妇女的糖尿病发病率，但这种策略是否对妊娠期糖尿病妇女有效尚不清楚。最近患有妊娠期糖尿病的妇女，即使不再怀孕，也面临着改变生活方式的重大障碍，包括对风险和照顾责任的低认识。基于网络的程序可以通过计步器输出的视觉反馈、定制的消息传递、教育和在线社区来加强身体活动；这样的程序目前适用于患有慢性病的成年人。对于特定的目标1，我们建议调整这个基于网络的计步器程序，以适应最近患有妊娠期糖尿病的女性。对于特定的目标2，我们建议通过随机对照试验来初步测试该计划的有效性。最近患有妊娠期糖尿病的妇女将随机接受常规护理(n=50)和基于网络的计步器计划(n=50)。主要结果是通过曲线下的葡萄糖面积测量的葡萄糖耐量；次要结果包括体重减轻和体力活动。构思、设计和实施目前可用的计划的调查人员和工作人员将帮助适应最近患有妊娠期糖尿病的妇女，并为最近患有妊娠期糖尿病的妇女测试该计划。试点研究将为全面试验产生样本量估计。最近患有妊娠期糖尿病的妇女的适应情况将通过PIS调查和最近患有妊娠期糖尿病的妇女的焦点小组工作来了解，这是她获得NIDDK K23奖的一部分，目前已进入第二个年头。这部K23的作品已经产生了10多本第一作者的出版物，研究了最近患有妊娠期糖尿病的女性。研究团队由女性糖尿病护理、体力活动、信息技术和行为改变方面的专家组成。该提案将利用普通临床研究中心类型的设施进行摄入量评估，利用专门应用新技术改变健康行为的密歇根健康传播研究中心，利用密歇根糖尿病研究和培训中心进行高质量的血糖分析，以及来自K赠款的财政和其他资源。因此，该提案利用当地的大量资源，为这一不断增长的高危妇女群体研究一种新的、亟需的干预措施。

DESCRIPTION (provided by applicant): Ten to 50% of women with gestational diabetes (GDM), or glucose intolerance first recognized during pregnancy, develop type 2 diabetes (type 2 DM) within 5 years after delivery. Although intensive interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is unknown if such strategies would be effective in women with GDM. Women with recent GDM, even though no longer pregnant, face significant barriers to lifestyle modification, including low perception of risk and caregiving responsibilities. Web-based programs can reinforce physical activity through visual feedback of pedometer output, tailored messaging, education, and on-line communities; such a program is currently available for adults with chronic disease. For Specific Aim 1, we propose to adapt this web-based pedometer program to women with recent GDM. For Specific Aim 2, we propose to pilot test the program effectiveness with a randomized controlled trial. Women with recent GDM will be randomized to receive usual care (n=50) vs. the web-based pedometer program (n=50). The primary outcome will be glucose tolerance as measured by glucose area under the curve; secondary outcomes include weight loss and physical activity. Investigators and staff who conceived of, designed, and implemented the currently available program will aid in the adaptation to women with recent GDM and testing of the program for women with recent GDM. The pilot study will generate sample size estimates for a full-scale trial. The adaptation to women with recent GDM will be informed by the PIs survey and focus group work in women with recent GDM performed as part of her NIDDK K23 award, now in its 2nd year. This K23 work has generated over 10 first-author publications examining women with recent GDM. The research team consists of experts in diabetes care in women, physical activity, information technology, and behavioral change. The proposal will utilize General Clinical Research Center-type facilities for intake assessment, the Michigan Center for Health Communications Research that specializes in the application of new technologies to health behavior change, the Michigan Diabetes Research and Training Center for high quality glucose assays, and the financial and other resources from the K grant. As a result, the proposal leverages the considerable local resources to investigate a novel and much needed intervention for this growing, high-risk population of women.