The Patients With Gestational Diabetes Were Interfered With Qigong.

July 18, 2023 updated by: Chen Chaoyang

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
Time Frame: Weeks 0 and 13
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
Time Frame: Weeks 0 and 13
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
Time Frame: Weeks 0 and 13
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

Other Outcome Measures

Outcome Measure
Time Frame
Maternal and infant complications during childbirth
Time Frame: birth
birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen Chaoyang

Collaborators

Shanghai First Maternity and Infant Hospital

Investigators

  • Principal Investigator: Li Jie, Doctor, Shanghai University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZY(2021-2023)- 0105-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study is still in the exploratory stage and has a certain degree of confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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