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

针对有 GDM 病史的女性的试点生活方式干预：PEG 研究

• 批准号: 7637097
• 负责人: CATHERINE KIM
• 金额: $ 7.73万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7637097
• 关键词: Adult; Affect; Area Under Curve; Award; Behavior; Behavioral; Biological Assay; Body Weight decreased; Caring; Child; Chronic Disease; Clinical Research; Collaborations; Communication Research; Communities; Computer Graphics; Computer software; Data; Diabetes Mellitus; Diabetes prevention; Education; Effectiveness; Effectiveness of Interventions; Epidemic; Face; Focus Groups; Funding; Gestational Diabetes; Glucose; Glucose Intolerance; Grant; Health Communication; Health behavior change; Human Resources; Incidence; Information Technology; Intake; Intervention; K-Series Research Career Programs; Length; Life Style; Measures; Mentored Patient-Oriented Research Career Development Award; Michigan; Modification; Multimedia; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Obesity; Online Systems; Output; Perception; Persons; Phase; Physical activity; Pilot Projects; Population; Postpartum Period; Pregnancy; Prevalence; Preventive; Preventive Intervention; Program Development; Program Effectiveness; Publications; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recording of previous events; Reliance; Research; Research Personnel; Research Training; Resources; Sample Size; Social support; Surveys; Systems Integration; Technology; Test Result; Testing; United States; Upper arm; Woman; Work; advanced maternal age; caregiving; cost; design; diabetes prevention program; diabetes risk; effective intervention; flexibility; glucose tolerance; graphical user interface; health information technology; high risk; impaired glucose tolerance; improved; lifestyle intervention; meetings; new technology; novel; pregnant; primary outcome; programs; risk perception; secondary outcome; tailored messaging; treatment as usual; visual feedback

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.

描述（由申请人提供）： 患有妊娠糖尿病 (GDM) 或在怀孕期间首次发现葡萄糖不耐受的女性中有 10% 至 50% 在分娩后 5 年内发展为 2 型糖尿病 (2 型 DM)。尽管强化干预措施可以降低糖耐量受损女性的糖尿病发病率，但尚不清楚此类策略对 GDM 女性是否有效。近期患有 GDM 的女性，即使不再怀孕，在改变生活方式方面也面临着巨大的障碍，包括对风险和护理责任的认识较低。基于网络的程序可以通过计步器输出的视觉反馈、定制消息、教育和在线社区来加强身体活动；目前，患有慢性病的成年人可以享受这样的计划。对于具体目标 1，我们建议针对近期患有 GDM 的女性调整这个基于网络的计步器程序。对于具体目标 2，我们建议通过随机对照试验来试点测试该计划的有效性。最近患有 GDM 的女性将被随机分配接受常规护理 (n=50) 与基于网络的计步器计划 (n=50)。主要结果是通过葡萄糖曲线下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、设计和实施当前可用计划的研究人员和工作人员将帮助适应近期 GDM 的女性，并针对近期 GDM 的女性测试该计划。该试点研究将为全面试验生成样本量估计。对近期 GDM 女性的适应将通过 PI 调查和对近期 GDM 女性的焦点小组工作来了解，这是她的 NIDDK K23 奖的一部分，现已进入第二年。这项 K23 工作已产生 10 多篇第一作者出版物，研究近期患有 GDM 的女性。该研究团队由女性糖尿病护理、体育活动、信息技术和行为改变方面的专家组成。该提案将利用一般临床研究中心类型的设施进行摄入评估、专门从事新技术应用以改变健康行为的密歇根健康传播研究中心、进行高质量葡萄糖检测的密歇根糖尿病研究和培训中心以及来自 K 赠款的财务和其他资源。因此，该提案利用大量当地资源，针对这一不断增长的高危女性群体，研究一种新颖且急需的干预措施。