Back to resultsThe Patients With Gestational Diabetes Were Interfered With Qigong.
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Qigong
guidance of nutrition and exercise
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring Gestational Diabetes Mellitus in Pregnancy, Qigong, Non-drug therapy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Qigong group
Control group
Arm Description
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.
guidance of nutrition and exercise
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05951621
First Posted
July 11, 2023
Last Updated
July 18, 2023
Sponsor
Chen Chaoyang
Collaborators
Shanghai First Maternity and Infant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05951621
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chen Chaoyang
Collaborators
Shanghai First Maternity and Infant Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
Keywords
Gestational Diabetes Mellitus in Pregnancy, Qigong, Non-drug therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Qigong group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
guidance of nutrition and exercise
Intervention Type
Other
Intervention Name(s)
Qigong
Intervention Description
An ancient Chinese system of postures, exercises, breathing techniques, and meditations designed to improve and enhance the body's QI.
Intervention Type
Behavioral
Intervention Name(s)
guidance of nutrition and exercise
Intervention Description
Provide health promotion and guidance to participants on diet and physical exercise
Primary Outcome Measure Information:
Title
Fasting blood glucose
Description
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.
Title
2-h postprandial plasma glucose
Description
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 Outcome Measure Information:
Title
Pittsburgh sleep quality index,PSQI
Description
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
Title
Self-Rating Depression Scale，SDS
Description
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
Title
Self-Rating Anxiety Scale, SAS
Description
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 Pre-specified Outcome Measures:
Title
Maternal and infant complications during childbirth
Time Frame
birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chen chaoyang, Master
Phone
15002153216
Email
675694333@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Jie, Doctor
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This study is still in the exploratory stage and has a certain degree of confidentiality
Citations:
PubMed Identifier
35660387
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.
Results Reference
background
PubMed Identifier
29055674
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.
Results Reference
background
PubMed Identifier
33184151
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.
Results Reference
background
PubMed Identifier
28639706
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.
Results Reference
background
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