Gestational Diabetes Research
Project Title: 24-Hour Activity and Cardiometabolic Health in Chinese American Women with a History of Gestational Diabetes
Introduction: This is a nursing research study to characterize the 24-hour activity and cardiometabolic risk profile for Chinese American women with a history of gestational diabetes [GD]. The purpose of this mixed method study is to describe the multi-contextual barriers and facilitators to meet current physical activity and sleep guidelines for the targeted population. Gestational diabetes is a type of diabetes that is diagnosed for the first time during pregnancy. Your cardiometabolic risk profile includes your blood sugar level, blood cholesterol or triglyceride levels, blood pressure, body fat percentage, and so on, together they influence your risk of heart disease, stroke, and diabetes.
简介：本项护理研究项目旨在解析有妊娠糖尿病 [GD] 病史的在美华人女性 24 小时身体活动和心血管代谢健康风险的概况。 这项混合方法研究的目的是描述上述女性在尝试达到“身体活动与睡眠指南”的标准时所遇到 的障碍和促进因素。 妊娠糖尿病是指在妊娠期被首次诊断出的一种糖尿病。您的心脏代谢风险概 况包括您的血糖水平、血胆固醇或甘油三酯水平、血压、体脂率等等，所有的这些因素共同影响 着您罹患心脏病、中风和糖尿病的风险。
简介：本项护理研究项目旨在解析有妊娠糖尿病 [GD] 病史的在美华人女性 24 小时身体活动和心血管代谢健康风险的概况。 这项混合方法研究的目的是描述上述女性在尝试达到“身体活动与睡眠指南”的标准时所遇到 的障碍和促进因素。 妊娠糖尿病是指在妊娠期被首次诊断出的一种糖尿病。您的心脏代谢风险概 况包括您的血糖水平、血胆固醇或甘油三酯水平、血压、体脂率等等，所有的这些因素共同影响 着您罹患心脏病、中风和糖尿病的风险。
What are the benefits of volunteering to take part in this research?
Participation in this research study may not yield personal benefits, but you may:
Participation in this research study may not yield personal benefits, but you may:
- Comprehensive assessment of your 24-hour activity and cardiometabolic health profile.
- Enhanced understanding of your own 24-hour activity and cardiometabolic health.
- Potential for positive lifestyle behavioral changes, such as improved physical activity and/or sleep habits.
- Receive compensation for taking part in the study
志愿者参加这项研究有什么好处？
参与这项研究可能不会为您个人带来直接好处，但您可以获得：
参与这项研究可能不会为您个人带来直接好处，但您可以获得：
- 对您的24小时活动和心脏代谢健康状况进行全面评估。
- 更深入了解您自己的24小时活动和心脏代谢健康。
- 有可能产生积极的生活方式行为改变，例如改善体育活动和/或睡眠习惯。
- 获得参与研究的报酬。
Who can participate in the research study?
Women aged between
- 18-50 with menstruation;
- Self-identified as Chinese or with Chinese ancestry;
- Born outside of the US or born in the US;
- Residing in the US;
- Self-reported diagnosis of GD during at least one pregnancy;
- Speak English or Chinese (Mandarin);
- At least one child delivered from the index pregnancy is between age 6 months to 5 years old.
谁可以参与研究？
- 年龄在18至50岁之间的女性，有月经；
- 自认为是华人或有华人血统；
- 出生在美国以外或出生在美国；
- 目前居住在美国；
- 自报至少在一次怀孕期间被诊断为糖尿病；
- 会说英语或中文（普通话)；
- 至少有一个儿童的年龄在6个月至5岁之间。
How long is required for the volunteer to participate in the research study?
- This study will last about two weeks for the participants.
志愿者参加研究需要多长时间？
- 这项研究将为参与者持续大约两周。
What will participants do?
Volunteers who take part in this nursing research study may:
Volunteers who take part in this nursing research study may:
- Wear two activity monitors (one waist and one wrist) for 7 consecutive days.
- Take part in an audio-taped interview lasting about 30 minutes
- Complete one set of online surveys
- Go to one in-person visit to the NYU Clinical Research Center. There are three locations to choose from:
-
1) Manhattan location: 4th Floor of Bellevue Hospital C/D building, 462 First Avenue
- Open 8 AM - 5 PM, Monday - Friday
-
2) Brooklyn location: 159 55th Street, Augustana Building 2nd Floor, Brooklyn, NY 11220
- Open 9 AM - 5 PM, Monday - Friday
-
3) Long Island location: 101 Mineola Blvd, Suite 3-002, Mineola, NY 11501
- Open 7 AM - 4 PM, Monday - Friday
-
1) Manhattan location: 4th Floor of Bellevue Hospital C/D building, 462 First Avenue
志愿者需要做什么？
参加本护理研究的志愿者需要：
参加本护理研究的志愿者需要：
- 连续7天佩戴两个活动记录仪 (分别佩戴在您的腰间和手腕上)
- 参与一个约30分钟的录音访谈
- 完成一组约30分钟的问卷调查
- 前往纽约大学临床研究中心进行一次的抽血体检, 有三个研究中心可任意选择
What type of wearable activity monitor is used for the research study?
该研究使用什么类型的可穿戴活动监测仪？
-- ActiGraph GT9X Link.
High Precision Motion Tracking for Multiple Wear Locations
多佩戴点位高精度活动监测仪
该研究使用什么类型的可穿戴活动监测仪？
-- ActiGraph GT9X Link.
High Precision Motion Tracking for Multiple Wear Locations
多佩戴点位高精度活动监测仪
How will the volunteer participants be compensated?
You will receive reimbursement for each part of the study your time and travel expenses as outlined below:
You will receive reimbursement for each part of the study your time and travel expenses as outlined below:
- You will receive 1 $20 gift card when you complete the online surveys
- You will receive 1 $40 gift card when complete the visit to the Clinical Research Center.
- You will receive 1 $20 gift card when you return the activity monitors.
- You will receive 1 $20 gift card when you complete the audio-taped interview.
If you complete all study components your total reimbursement will be $100.
You will receive travel reimbursement (equivalent value of MetroCard) for your travel to the Clinical Research Center for the study. Your childcare needs are considered as well, as we will provide toys and games for the children during the visit, and tangible items (e.g., crayons, toy balls) as gifts to your family.
参与者如何获得报酬？
每当您完成研究的一部分之后，您都会收到报酬。与此同时，您的交通费也会由我们支付，详情如下：
You will receive travel reimbursement (equivalent value of MetroCard) for your travel to the Clinical Research Center for the study. Your childcare needs are considered as well, as we will provide toys and games for the children during the visit, and tangible items (e.g., crayons, toy balls) as gifts to your family.
参与者如何获得报酬？
每当您完成研究的一部分之后，您都会收到报酬。与此同时，您的交通费也会由我们支付，详情如下：
- 完成在线调查后即可收到一张价值 20 美元的礼品卡
- 访问完临床研究中心后即可收到一张价值 40 美元的礼品卡。
- 归还活动监视器后即可收到一张20 美元的礼品卡。
- 完成录音采访后即可收到一张价值 20 美元的礼品卡。
如果您顺利完成研究的所有部分，您总共会收到100美元的感谢金。
您将获得前往临床研究中心参加研究的差旅费报销（等量价值的地铁卡）。考虑到您的育儿需求，我们会在访问期间为孩子们提供玩具和游戏，并为您的家人提供有形物品（如蜡笔、玩具球）作为礼物。
您将获得前往临床研究中心参加研究的差旅费报销（等量价值的地铁卡）。考虑到您的育儿需求，我们会在访问期间为孩子们提供玩具和游戏，并为您的家人提供有形物品（如蜡笔、玩具球）作为礼物。
How can I volunteer?
- Scan the QR code below and fill in the sign up form for volunteering.
我怎样才能报名成为研究志愿者？
- 您可以扫码下方的二维码填写报名表格成为志愿者
Foreseeable Risk
We do not anticipate any life-threatening or serious risks for this research study. Some of the questions on the surveys may make you feel uncomfortable or upset, but you can refuse to answer any questions that you do not wish to answer. A comprehensive list of all possible risks related to this research is included in the full informed consent.
可预见的风险
我们预计本研究不会有任何严重的或危及生命的风险。调查中的一些问题可能会让您感到不舒服或心烦意乱，但您可以拒绝回答任何您不想回答的问题。与本研究相关的所有可能风险和不适的完整列表包含在完全知情同意书中。
We do not anticipate any life-threatening or serious risks for this research study. Some of the questions on the surveys may make you feel uncomfortable or upset, but you can refuse to answer any questions that you do not wish to answer. A comprehensive list of all possible risks related to this research is included in the full informed consent.
可预见的风险
我们预计本研究不会有任何严重的或危及生命的风险。调查中的一些问题可能会让您感到不舒服或心烦意乱，但您可以拒绝回答任何您不想回答的问题。与本研究相关的所有可能风险和不适的完整列表包含在完全知情同意书中。
How to contact us?
- Send an email to gdm.study@nyu.edu if you have any questions about the research.
- You can also reach us by phone: 212-992-7178 or 212-992-7352
怎样联系我们？
- 发送电子邮件至 gdm.study@nyu.edu 报名参与妊娠糖尿病研究。
- 您也可以电话联系我们：212-992-7178 或 212-992-7352
Informed Consent and Key Information
知情同意书和重要信息说明下载
知情同意书和重要信息说明下载
FAQ (Frequently Asked Questions)
1. What are the devices?
- The name of the activity monitor is ActiGraph GT9X+. It is a research-grade medical device, and it passed the safety standard in the US.
2. How do the devices work?
- ActiGraph uses an accelerometer to detect the speed of movement of our body in 3D directions. It is similar to Fitbit, the fitness watch, but it is even more accurate.
3. How should I wear the devices?
- Please wear one device to the right side of your waist (as shown in the picture) and the other to your non-dominant hand's wrist.
4. What is cardiometabolic health?
- Cardiometabolic health refers to your heart, blood, blood vessels, and metabolic health. The lab results that we are measuring are markers of the health of your cardiovascular and metabolic system.
5. What happens during the in-person visit at the Clinical Research Center?
- At the Clinical Research Center, the nurse will assess your vital signs, height, and weight. Your waist and body fat percentage will also be measured. In addition, a blood sample of one tablespoon (15ml) will be collected to analyze your blood glucose profile, including hemoglobin A1c, fasting blood glucose, and fasting insulin. The lipid panel will also be evaluated, including total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides.
6. How is the in-depth interview conducted?
- The In-depth Interview can take place either in person or via Zoom, based on your preference. It's important to note that not every participant will undergo an interview. Incentives for this study component will only be provided to participants who have successfully completed the interview.
FAQ （常见问题）
1. 佩戴的仪器是什么？
- 我们给您邮寄的是活动监测仪，英文名字叫ActiGraph GT9X+。它是研究专用医用设备，且通过了美国FCC安全认证。
2. 这个仪器怎么运作？
- 活动监测仪的原理是用三维的加速器感应身体的各个方向的加速度。它类似运动手环fitbit，但是监测更准确。
3. 我应该如何佩戴这个仪器？
- 请您像图片（见下方）中的一样将一个仪器戴到腰的右侧，另外一个仪器戴到您的非常用手的手腕上。
4. 什么是心血管健康？
- 心脏代谢健康是指您的心脏、血液、血管和代谢健康。 我们体检时测量的数据标志了您心血管系统和代谢系统的健康状况。
5. 去纽约大学临床研究中心时都会发生什么？是什么流程？
- 当您到了临床研究中心以后，那里的护士将会测量您的生命体征、身高和体重，同时还会测量您的腰围和身体脂肪百分比。 此外，护士还将收集一汤匙（15 毫升）的血液样本来分析您的血糖状况，包括糖化血红蛋白、空腹血糖和空腹胰岛素，还有脂质组，包括总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇和甘油三酯。
6. 深度访谈是怎么做的？
- 深度访谈可以面对面进行，也可以通过线上的方式进行，根据您的喜好来。需要注意的是，并非每个参与者都会接受我们的深度访谈，只有成功完成访谈的参与者才会收到这一部分的研究报酬。
