Gestational Diabetes Mellitus
Conditions
Interventions
Home-based digital lifestyle program :Participants randomized to the intervention group will engage in a comprehensive home-based exercise and diet program delivered and monitored via a dedicated smar
Clinic-based standard lifestyle program:Clinic-based standard lifestyle program – Participants in this arm will receive the usual care for GDM as per current practice, consisting of face-to-face exerc
Sponsors
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Gestational age of enrollment =5.1 mmol/L but =5.1 mmol/L), but does not reach the standard of overt diabetes. A significant increase in fasting blood glucose (>=7.0 mmol/L) or HbA1c>=6.5% at the time of filing is regarded as preconception overt diabetes (see exclusion criteria) 5. A history of gestational diabetes mellitus (GDM) combined with elevated blood glucose in the very early stage of this pregnancy can be diagnosed as recurrent GDM requiring immediate treatment. Age: 18 to 45 years old. We included the adult pregnant women group and set an upper age limit to eliminate risks related to extreme age. Pregnant women over 45 May face a higher obstetric risk or be more likely to have type 2 diabetes rather than true gestational hyperglycemia. 6. Singleton pregnancy: Only cases of singleton pregnancy are included. Multiple pregnancies (twins and more) are excluded due to differences in metabolic characteristics and obstetric risks. Twin pregnancies themselves have a higher baseline risk of gestational diabetes mellitus (GDM) and special nutritional requirements, which will interfere with the evaluation of the effectiveness of intervention measures. 7. Have the conditions to use mobile applications and the Internet: As the intervention group needs to be implemented through an application, participants must have a compatible smart phone or tablet device and be willing to use the application regularly. This includes mastering basic technical operation skills (such as installing and navigating applications) and having a stable network connection. We will provide basic guidance. Participants are eligible as long as they do not have serious usage disorders (such as cognitive impairment or language barriers). 8. Informed consent: Voluntarily participate in the research and sign a written informed consent form. Participants are required to understand the research process, agree to accept random grouping intervention, and commit to complying with the protocol requirements: including attending the assessment on time, (for the control group) participating in the exercise/diet guidance course, or (for the intervention group) using the application as required.
Exclusion criteria
Exclusion criteria: 1. Overt preconception diabetes: Pregnant women who were clearly diagnosed with type 1 or type 2 diabetes before pregnancy or during their first prenatal checkup (such as fasting blood glucose >=7.0 mmol/L at 7 weeks of pregnancy, glycated hemoglobin >=6.5%, or who had already taken hypoglycemic drugs before pregnancy). This study focuses on gestational diabetes or early-detected gestational hyperglycemia. Different management plans should be adopted for patients with diagnosed diabetes, and they are usually treated as pre-pregnancy diabetes. 2. Contraindications for exercise: Situations where there are medical or obstetric contraindications and moderate exercise cannot be carried out safely. For example: severe bleeding in the early stage of pregnancy (threatened miscarriage), placenta previa in the middle and late stages of pregnancy, cervical insufficiency requiring cerclage, severe musculoskeletal limitation, or other complications that obstetric recommendations suggest avoiding exercise. At the same time, exclude those whose exercise tolerance is limited due to severe chronic diseases (such as uncontrolled hypertension, major heart disease, and advanced lung disease). 3. Multiple pregnancies: As mentioned earlier, due to differences in management needs and outcomes, twin or more pregnancies are not included. 4. History of bariatric surgery or malabsorption: Individuals who have undergone bariatric surgery or suffer from gastrointestinal diseases that seriously affect nutrient absorption have special nutritional monitoring needs that are incompatible with the standard dietary intervention framework. 5. Participation in other intervention trials: To avoid confounding factors, those currently participating in other clinical trials that may affect GDM or pregnancy outcomes will be excluded to ensure that the observed effects are solely derived from the intervention measures in this study. 6. Failure to complete follow-up: Pregnant women who plan to give birth in non-cooperative hospitals or move out of the region before the end of the study (one year postpartum) will not be included as their long-term follow-up data may be missing. Participants are required to commit to completing the postpartum follow-up as per the protocol. Refusal to use technology (applicable to the intervention group) : If a woman is randomly assigned to the intervention group but subsequently refuses to use the application or encounters unsolvable technical problems (for example, not owning a smart phone and unable to obtain the provided device), it constitutes an actual exclusion. However, it is best to identify this situation before random grouping (we will confirm their willingness and ability to use it during the screening stage). If it is found after random grouping, it will be treated as an exit. 7. Basis for standard development: The inclusion criteria we selected are designed to identify the patient population that indeed has gestational diabetes mellitus (GDM) or is at high risk in the early stage of pregnancy and is suitable for exercise and diet intervention. By focusing on the early stage of pregnancy, we hope to intervene at the stage when lifestyle changes can have the greatest impact on the course of GDM. The exclusion criteria were used to ensure safety (avoiding risks for patients with contraindications to exercise) and maintain a relatively homogeneous GDM study population, rather than patients with other types of diabetes or pregnancy complicat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse pregnancy outcomes related to gestational diabetes mellitus (composite indicators); | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;Fasting and postprandial blood glucose;6 minutes walk test, MWT;SF-36 Health Survey;Hospital Anxiety and Depression Scale; | — |
Countries
China
Contacts
Public ContactZhu Xiaolu
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed