Gestational Diabetes Mellitus in PregnancyNCT05951621
The Patients With Gestational Diabetes Were Interfered With Qigong.
A study testing Qigong and guidance of nutrition and exercise in people with Gestational Diabetes Mellitus in Pregnancy, run by Chen Chaoyang.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Qigong and guidance of nutrition and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Qigong on Gestational Diabetes Mellitus：A Randomized Controlled Trial
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.
- Being tested
- Qigong, guidance of nutrition and exercise
- Keywords
- Gestational Diabetes Mellitus in Pregnancy, Qigong, Non-drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongOther
An ancient Chinese system of postures, exercises, breathing techniques, and meditations designed to improve and enhance the body's QI.
guidance of nutrition and exerciseBehavioural
Provide health promotion and guidance to participants on diet and physical exercise
| Study group | Role | What they receive |
|---|---|---|
| Qigong group | Experimental | 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. Receives: Other: Qigong |
| Control group | Experimental | guidance of nutrition and exercise Receives: Behavioral: guidance of nutrition and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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-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.
Measured: 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 (3)
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.
Measured: Weeks 0 and 13
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.
Measured: Weeks 0 and 13
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.
Measured: Weeks 0 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Chaoyang
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai First Maternity and Infant Hospital
- Responsible party
- Sponsor-investigator, Chen Chaoyang, Shanghai University of Traditional Chinese Medicine
- Investigators
- Li Jie, Doctor, Principal investigator, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951621
- Sponsor's protocol ID
- ZY(2021-2023)- 0105-14
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is still in the exploratory stage and has a certain degree of confidentiality
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 35660387Sklempe 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 29055674Yew 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 33184151Brown 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Qigong on Gestational Diabetes Mellitus：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05951621
- Acronym / sponsor ID
- ZY(2021-2023)- 0105-14
- Keywords
- Gestational Diabetes Mellitus in Pregnancy, Qigong, Non-drug therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chen ChaoyangUniversity, hospital or other
- Collaborators
- Shanghai First Maternity and Infant Hospital
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong group | Experimental | Other: QigongOn 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. |
| Control group | Experimental | Behavioral: guidance of nutrition and exerciseguidance of nutrition and exercise |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QigongAn ancient Chinese system of postures, exercises, breathing techniques, and meditations designed to improve and enhance the body's QI. | Other | Qigong group |
| guidance of nutrition and exerciseProvide health promotion and guidance to participants on diet and physical exercise | Behavioural | Control group |
Primary outcome
Fasting blood glucose
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.
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.
2-h postprandial plasma glucose
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.
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.
3 secondary outcomes
Pittsburgh sleep quality index,PSQI
Time frame: Weeks 0 and 13
Self-Rating Depression Scale，SDS
Time frame: Weeks 0 and 13
Self-Rating Anxiety Scale, SAS
Time frame: Weeks 0 and 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 35660387Jin 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.
- Background: PubMed 29055674Sklempe 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.
- Background: PubMed 33184151Yew 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.
- Background: PubMed 28639706Brown 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.
- Individual participant dataSharing planned: No. This study is still in the exploratory stage and has a certain degree of confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Jie, Doctor principal investigator
Shanghai University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Qigong and guidance of nutrition and exercise in people with Gestational Diabetes Mellitus in Pregnancy, run by Chen Chaoyang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chen chaoyang, Master (15002153216, 675694333@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05951621, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.