The Patients With Gestational Diabetes Were Interfered With Qigong.

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Other: Qigong
* Behavioral: guidance of nutrition and exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qigong group<br>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<br>* An ancient Chinese system of postures, exercises, breathing techniques, and meditations designed to improve and enhance the body's QI.<br>|
| Experimental: Control group<br>guidance of nutrition and exercise | Behavioral: guidance of nutrition and exercise<br>* Provide health promotion and guidance to participants on diet and physical exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational Diabetes Mellitus in Pregnancy, Qigong, Non-drug therapy