The Patients With Gestational Diabetes Were Interfered With Qigong.

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

Effect of Qigong on Gestational Diabetes Mellitus：A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05951621
• Other study ID #: ZY(2021-2023)- 0105-14
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: March 2026

Study information

• Verified date: July 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: chen chaoyang, Master
• Phone: 15002153216
• Email: 675694333[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about in women with gestational diabetes's health conditions. The main question[s] it aims to answer are: - Can Qigong control blood glucose in women with gestational diabetes? - Can Qigong improve mood and sleep in women with gestational diabetes? Participants will required to follow the research team for 3 months of qigong practice。 If there is a comparison group: Researchers will compare Qigong groups to see if Qigong's effects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 20 years old= age = 40 years old;
• Those with clear awareness, acceptable reading and language expression skills, and barrier-free communication;
• singleton pregnancy;
• gestational age between 24 and 28 weeks, with the upper limit of gestational age set at 28 weeks at the time of inclusion to allow for at least 8 weeks of intervention;
• Body mass index (BMI) is lower than 40;
• Agree to participate in this project and sign the informed consent form.

Exclusion Criteria:

• Those with previous GDM and diabetes;
• Artificial insemination;
• Those with serious obstetric complications and contraindications;
• Participants in other planned and supervised exercise programs or researchers during the study.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Other:
• Qigong
An ancient Chinese system of postures, exercises, breathing techniques, and meditations designed to improve and enhance the body's QI.

Behavioral:
• guidance of nutrition and exercise
Provide health promotion and guidance to participants on diet and physical exercise

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chen Chaoyang	Shanghai First Maternity and Infant Hospital

References & Publications (4)

Brown J, Ceysens G, Boulvain M. Exercise for pregnant women with gestational diabetes for improving maternal and fetal outcomes. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012202. doi: 10.1002/14651858.CD012202.pub2. — View Citation

Jin Y, Chen Z, Li J, Zhang W, Feng S. Effects of the original Gymnastics for Pregnant Women program on glycaemic control and delivery outcomes in women with gestational diabetes mellitus: A randomized controlled trial. Int J Nurs Stud. 2022 Aug;132:104271. doi: 10.1016/j.ijnurstu.2022.104271. Epub 2022 Apr 28. — View Citation

Sklempe Kokic I, Ivanisevic M, Biolo G, Simunic B, Kokic T, Pisot R. Combination of a structured aerobic and resistance exercise improves glycaemic control in pregnant women diagnosed with gestational diabetes mellitus. A randomised controlled trial. Women Birth. 2018 Aug;31(4):e232-e238. doi: 10.1016/j.wombi.2017.10.004. Epub 2017 Oct 18. — View Citation

Yew TW, Chi C, Chan SY, van Dam RM, Whitton C, Lim CS, Foong PS, Fransisca W, Teoh CL, Chen J, Ho-Lim ST, Lim SL, Ong KW, Ong PH, Tai BC, Tai ES. A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, and Maternal and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study. Diabetes Care. 2021 Feb;44(2):456-463. doi: 10.2337/dc20-1216. Epub 2020 Nov 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal and infant complications during childbirth		birth
Primary	Fasting blood glucose	If the blood glucose level is between 4.0 and 5.4 mmol/L, the result is normal. If the fasting blood glucose level is between 5.5-6.9 mmol/L, the condition is called prediabetes. Diabetes refers to blood sugar greater than 8.5 mmol/L.	Average peripheral fasting blood glucose measured one week prior to participant enrollment. Fasting blood glucose measured in the first week after the end of 12 weeks of intervention.
Primary	2-h postprandial plasma glucose	less than 7.8mmol/L. When the blood glucose is 7.8~11.1 mmol/L 2 hours after meals, it can be diagnosed as impaired or impaired glucose tolerance.	Average postprandial blood glucose measured in the week prior to study participant enrollment. Average postprandial 2-hour postprandial peripheral capillary blood glucose measured in the first week after the end of 12 weeks of intervention.
Secondary	Pittsburgh sleep quality index,PSQI	PSQI was used to measure the sleep quality of participants in the last 1 month. It consists of 19 self-assessment items and 5 other assessment items, of which the 19th self-assessment item and 5 other evaluation items do not participate in scoring, and only 18 self-assessment items participating in scoring are introduced here. 18 items composed of 7 components, each component is scored on a scale of 0-3, the cumulative score of each component is the total score of PSQI, the total score range is 0-2l, the higher the score, the worse the sleep quality.	Weeks 0 and 13
Secondary	Self-Rating Depression Scale,SDS	SDS is rated according to the frequency of symptoms and is divided into 4 levels: no or very little time, a small amount of time, a considerable amount of time, and most or all the time. If it is a positive scoring question, it is rated as a rough score of L, 2, 3, and 4. For reverse grading questions, they are rated as 4, 3, 2, and 1. The assessment time is within the past week, add the scores of each question to a rough score, multiply the rough score by 1.25, and round up the whole number to get the standard score (T). The threshold value of depression assessment is T=53, and the higher the score, the more obvious the tendency to depression.	Weeks 0 and 13
Secondary	Self-Rating Anxiety Scale, SAS	SAS includes 20 items, and the score is based on a standard scoring pattern, with a score of 50 or less being normal, 50-59 being mild anxiety, 60-69 being moderate anxiety, and 70-79 being severe anxiety.	Weeks 0 and 13