Dietary Management of Gestational Diabetes Mellitus

Healthy Clinical Trial

Official title:

Dietary Management of Gestational Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05613920
• Other study ID #: QDU-HEC-2021149
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: February 2023

Study information

• Verified date: October 2022
• Source: Qingdao University
• Contact: Heng Liu
• Phone: 86-0532-82991205
• Email: hengliu[@]qdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Diet
• Gestational Diabetes Mellitus in Pregnancy
• Healthy
• Pregnancy in Diabetics

Intervention

Behavioral:
• diet 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.

Locations

Country	Name	City	State
China	Wenyao Geng	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

References & Publications (5)

Chen L, Zhang W, Fu A, Zhou L, Zhang S. Effects of WeChat platform-based nursing intervention on disease severity and maternal and infant outcomes of patients with gestational diabetes mellitus. Am J Transl Res. 2022 May 15;14(5):3143-3153. eCollection 20 — View Citation

Kapur K, Kapur A, Hod M. Nutrition Management of Gestational Diabetes Mellitus. Ann Nutr Metab. 2021 Feb 1:1-13. doi: 10.1159/000509900. [Epub ahead of print] Review. — View Citation

Phillips JK, Skelly JM, Roberts LM, Bernstein IM, Higgins ST. Combined financial incentives and behavioral weight management to enhance adherence with gestational weight gain guidelines: a randomized controlled trial. Am J Obstet Gynecol MFM. 2019 Mar;1(1 — View Citation

Xu S, Yu Q, Mi J, Li H. Clinical efficacy of nutritional diet therapy on gestational diabetes mellitus. Am J Transl Res. 2022 May 15;14(5):3488-3493. eCollection 2022. — View Citation

Zhou S, Wang L, Chen J, Liu L, Wu X. Effects of individual dietary intervention on blood glucose level and pregnancy outcomes in patients with gestational diabetes mellitus: a retrospective cohort study. Ann Palliat Med. 2021 Sep;10(9):9692-9701. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Apgar score of newborn	Apgar score at 1 minute and 5 minutes after birth in both groups	Apgar score at 1 minute and 5 minutes after birth
Primary	Changes in blood glucose levels over time	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.	Pre-intervention, 1-month post-intervention and 3-months post-intervention
Secondary	pregnancy outcomes	Number of Participants with Premature, Cesarean delivery, Gestational hypertension, Giant baby, Fetal intrauterine distress	During the delivery of pregnant women, the relevant data of pregnancy outcome were collected by consulting medical records or telephone follow-up.