Clinical trial NCT05951621: The Patients With Gestational Diabetes Were Interfered With Qigong.
Official title: Effect of Qigong on Gestational Diabetes Mellitus：A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: Gestational Diabetes Mellitus in Pregnancy
Qigong
Non-drug therapy
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai First Maternity and Infant Hospital
First posted: 2023-07-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fasting blood glucose
timeFrame: 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.
measure: 2-h postprandial plasma glucose
timeFrame: 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 outcomes:
measure: Pittsburgh sleep quality index,PSQI
timeFrame: Weeks 0 and 13
measure: Self-Rating Depression Scale，SDS
timeFrame: Weeks 0 and 13
measure: Self-Rating Anxiety Scale, SAS
timeFrame: Weeks 0 and 13
Other outcomes:
measure: Maternal and infant complications during childbirth
timeFrame: birth
Locations:
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Li Jie, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.