Diet, Gestational Diabetes Mellitus in Pregnancy, Healthy
Conditions
Brief summary
The goal of this clinical trial is to test effect of dietary management program based on the nudge strategy in gestational diabetes mellitus patients. The main questions it aims to answer is whether the dietary management program is effective for the diet management behavior of gestational diabetes mellitus patients. Participants will receive a 12 week dietary management program. The intervention group will receive a diet management program based on the nudge strategy, and the control group will receive a routine dietary management program. Researchers will compare two group's glycemic control and pregnancy outcomes and to see if effective for the diet management behavior.
Interventions
BEHAVIORALdiet management program based on the nudge strategy
The intervention group received a 12-week dietary management intervention based on the nudge strategy. The MINDSPACE framework was used, which has nine intervention categories. Face-to-face intervention and telephone follow-up were used to provide targeted dietary management.
Sponsors
Qingdao University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Meeting the diagnostic criteria related to GDM by oral glucose tolerance test (OGTT), etc. 2. Singleton pregnancy 3. Age ≥ 18 years 4. Gestational weeks 24-28 5. Informed consent for voluntary participation in this study
Exclusion criteria
1.Patients with significant heart, liver, lung and other organ failure and malignancy 2.Previous history of psychiatric disorders or existing psychiatric disorders 3.Diabetes combined with other complications such as gestational hypertension Dropout criteria 1. Lost to the study due to unforeseen circumstances 2. Voluntarily requested to withdraw from the study 3. Did not take the intervention as required by the relevant requirements 4. Condition was unstable and could not continue to cooperate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood glucose levels over time | Pre-intervention, 1-month post-intervention and 3-months post-intervention | With the change of intervention and time, it is better for the fasting blood glucose to decrease; With the change of intervention and time, it is better that the 1hPG decreases; With the change of intervention and time, it is better that the 2hPG decreases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy outcomes | During the delivery of pregnant women, the relevant data of pregnancy outcome were collected by consulting medical records or telephone follow-up. | Number of Participants with Premature, Cesarean delivery, Gestational hypertension, Giant baby, Fetal intrauterine distress |
Other
| Measure | Time frame | Description |
|---|---|---|
| Apgar score of newborn | Apgar score at 1 minute and 5 minutes after birth | Apgar score at 1 minute and 5 minutes after birth in both groups |
Countries
China
Contacts
Primary ContactHeng Liu
Backup ContactHeng Liu
Outcome results
None listed