ACTIVE MOMS: Physical Activity Intervention for Women with Gestational Diabetes

描述（申请人提供）：这项拟议研究的总体目标是测试ACTIVE MOMS的有效性，ACTIVE MOMS是一项为期12周的认知行为体育活动计划，分为两种干预措施（半密集的结构性锻炼和最小接触的身体活动），以增加妊娠期糖尿病（GDM）妇女的身体活动行为，并确定该计划对母亲和胎儿结局的影响。由于GDM增加了母亲和胎儿的发病率，并且与这些妇女及其子女日后患2型糖尿病和肥胖症有关，因此研究干预措施以治疗和预防GDM至关重要。初步研究表明，体力活动可能是有效的治疗GDM;然而，这项研究的范围是有限的，到目前为止还没有研究1）干预GDM妇女的主要目标是增加他们的体力活动行为，和2）检查GDM妇女的体力活动行为与标准化的自我报告和客观评估相结合。此外，研究产妇体力活动对心理相关因素和婴儿结局的影响的研究很少。由于在标准护理环境中早期筛查和发现GDM，妇女将在妊娠17-18周时被确定为患有GDM。参与者将随机接受结构化锻炼、生活方式体力活动或标准护理控制条件。所有参与者将接受基线（妊娠约19周）和两次随访评估（妊娠约33周，产后6周），以测量一系列生物行为结果。将获得受试者及其后代的医疗记录，以评估妊娠生物标志物（例如，葡萄糖耐量、母体体重状况）、妊娠和分娩并发症以及婴儿出生结果。干预措施将在妊娠第二和第三个三个月（妊娠-20-32周）期间实施。主要结果是女性的身体活动行为（例如，平均计数/分钟、能量消耗、满足体力活动建议）。次要结果包括母亲体力活动行为对心理社会相关因素的影响（例如，身体活动态度、自我效能、社会支持;抑郁、生活质量），妊娠和分娩并发症（例如，母亲体重过度增加，需要胰岛素），和婴儿结果（例如，出生体重）。

DESCRIPTION (provided by applicant): The overall goal of this proposed research is to test the effectiveness of ACTIVE MOMS, a 12-week cognitive behavioral physical activity program, delivered as two interventions (semi-intensive structured exercise and minimum-contact physical activity), for increasing physical activity behaviors of women with gestational diabetes mellitus (GDM), and to determine the impact of this program on maternal and fetal outcomes. Because GDM increases maternal and fetal morbidity and it is associated with the onset of type 2 diabetes and obesity later in life for these women and their children, it is critically important that interventions be studied to treat and prevent GDM. Preliminary research has shown that physical activity may be effective at treating GDM; however, this research is limited in scope and no studies to date have 1) intervened with GDM women with a primary objective of increasing their physical activity behaviors, and 2) examined GDM women's physical activity behaviors with a combination of standardized self-report and objective assessments. Also, the research studying the effects of maternal physical activity on psychological correlates and infant outcomes in this population is scant. As a result of early screening and detection for GDM in the standard care setting, women will be identified as having GDM by 17-18 weeks gestation. Participants will be randomized to receive either the structured exercise, lifestyle physical activity, or standard care control condition. All participants will undergo a baseline (-19 weeks gestation) and two follow-up assessments (-33 weeks gestation, 6-weeks postpartum) to measure a series of biobehavioral outcomes. The medical records will be obtained for the participants and their offspring to assess pregnancy biomarkers (e.g., glucose tolerance, maternal weight status), pregnancy and delivery complications, and infant birth outcomes. The intervention will be implemented during the second and third pregnancy trimesters (-20-32 weeks gestation). The primary outcome is women's physical activity behaviors (e.g., mean counts/min, energy expenditure, meeting physical activity recommendations). Secondary outcomes include the effects of maternal physical activity behaviors on psychosocial correlates (e.g., physical activity attitude, self-efficacy, social support; depression, quality of life), pregnancy and delivery complications (e.g., excessive maternal weight gain, need for insulin), and infant outcomes (e.g., birth weight).