CClinicalTrials.gg
Not yet recruitingNCT05951621Updated Jul 19, 2023

The Patients With Gestational Diabetes Were Interfered With Qigong.

An interventional study of Qigong and guidance of nutrition and exercise in Gestational Diabetes Mellitus in Pregnancy, sponsored by Chen Chaoyang. Not yet recruiting. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-07-19.

Sponsored by Chen Chaoyang · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.
02

Conditions studied

  • Gestational Diabetes Mellitus in Pregnancy

Keywords

  • Gestational Diabetes Mellitus in Pregnancy
  • Qigong
  • Non-drug therapy
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 60 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

This is the only study on the registry with Chen Chaoyang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Qigong group

    On the basis of nutrition and exercise management and guidance, Qigong is exercised. Offline intensive learning once a week, 45-60 minutes each time, study for 12 weeks, and arrange online theory lecture once a week. In addition to concentrated learning, subjects in this group were required to practice themselves at home, at least once a day, each time for 30 minutes.

    Other: Qigong

  • Experimental
    Control group

    guidance of nutrition and exercise

    Behavioral: guidance of nutrition and exercise

Interventions

  • OtherQigong

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

  • Behavioralguidance of nutrition and exercise

    Provide health promotion and guidance to participants on diet and physical exercise

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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

  1. 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.

    Time frame: Weeks 0 and 13

  2. 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.

    Time frame: Weeks 0 and 13

  3. 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.

    Time frame: Weeks 0 and 13

Other outcomes

  1. Maternal and infant complications during childbirth

    Time frame: birth

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 35660387 ↗
  • 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. PubMed 29055674 ↗
  • 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. PubMed 33184151 ↗
  • 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. PubMed 28639706 ↗

Individual participant data

Plan to share: No — This study is still in the exploratory stage and has a certain degree of confidentiality

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05951621
Lead sponsor
Chen Chaoyang
Collaborators
Shanghai First Maternity and Infant Hospital
Responsible party
Chen Chaoyang (Shanghai Qigong Research Institute Trainee researcher, Shanghai University of Traditional Chinese Medicine) — Sponsor-investigator
First posted
Jul 19, 2023
Start date
Sep 2023 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Mar 2026 (estimated)
Last update
Jul 19, 2023

Study contacts

chen chaoyang, Master
Contact
675694333@qq.com
15002153216
Li Jie, Doctor
principal investigator · Shanghai University of Traditional Chinese Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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