Introduction: The purpose of the research study is to develop and test a culturally and linguistically tailored online nutrition program called LOTUS (Leveraging Online Teaching Kitchens for Chinese American Women with Gestational Diabetes). LOTUS will combine diabetes education, culturally relevant nutrition guidance, cooking demonstrations, cultural recipes, support from bilingual health professionals, and peer support for Chinese American women with gestational diabetes to improve your dietary management experience during pregnancy. The program will be delivered online through a dedicated website and familiar communication platforms such as WeChat, making it accessible to women like you regardless of where you live.

Are there any benefits to being in this research study?

There is a possibility that you may benefit from being in the study, but there is no guarantee that will happen.

• Possible benefits include a better understanding of gestational diabetes management, increased nutrition knowledge, improved dietary self-management skills, improved glycemic control during pregnancy, and improved psychosocial health and pregnancy outcomes.
• Even if you don’t benefit from being in the study, your participation may help us to learn more about if the LOTUS program will be feasible and acceptable for Chinese American women with gestational diabetes.
• We hope the knowledge gained from this study will benefit others in the future.

Why am I being asked to be in this research study?

We are asking you to be in this research study because you are a Chinese American woman with gestational diabetes.

How long will I be in the research study?

If you agree to be in the study, your participation will last for 6 weeks or until the delivery of your baby and will involve two remote study visits to complete questionnaires and assessments, and one exit interview.

What will happen if I say “Yes, I want to be in this research study”?

If you agree to be in this study, we will ask you to:

• Attend a 6-week online LOTUS program with comprehensive diabetes education, culturally relevant nutrition guidance, cooking demonstrations, cultural recipes, support from bilingual health professionals, and peer support for Chinese American women with gestational diabetes.

• You will complete data collection activities two times: at the beginning of the study (baseline) and at the end of 6 weeks. Each time, you will complete questions about what you eat, your mood, anxiety, social support, your weight, and your blood sugar management. These questions will take about 20-30 minutes to complete.

• You will complete an exit interview to share your experiences and satisfaction with the LOTUS program.

• Study staff will access your medical records to collect health information (information about this pregnancy and delivery, including ultrasound information and information about your baby, as well as information on your prior pregnancies and deliveries).

Will I be paid for being in this research study?

You will receive up to $100 in gift cards for taking part in this study:

• You will receive $20 for the baseline data collection

• You will receive $40 for participating in the LOTUS online teaching kitchen sessions and completing the exit interview

• You will receive $20 for the 6-week data collection, and

• You will receive $20 for sharing medical records

Will it cost me anything to be in this research study?

It will not cost you anything to be in this study. You will use your own smartphone or laptop and internet or cellular data to access the LOTUS program website and content.

Are there any possible risks to me?

It is possible that someone could find out you were in this study or see your study information, but we believe this risk is small because of the procedures we use to protect your information. These procedures are described later in this form. Other possible risks include:

• Some questions about your health, mood, or experiences may make you uncomfortable. You may skip any question. You may stop taking part at any time.

• Risks to your baby are minimal. The LOTUS promotes adherence to evidence-based prenatal nutrition recommendations and standard gestational diabetes self-management practices. The study will not require you to make medication changes based solely on study procedures. You will continue receiving routine prenatal and diabetes care from your healthcare providers. Risks to your baby are therefore expected to be no greater than minimal

Who can answer my questions about this research study?

If you have questions or concerns about this study or have experienced a research-related problem or injury, contact the PI, Dr. Shuyuan Huang, [email protected], 865-974-8328. For questions or concerns about your rights or to speak with someone other than the research team about the study, please contact:

Institutional Review Board

The University of Tennessee, Knoxville

Phone: 865-974-7697

Email: [email protected]