Clinical trial NCT05613920: Dietary Management of Gestational Diabetes Mellitus
Official title: Dietary Management of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Diet
Healthy
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in blood glucose levels over time
timeFrame: Pre-intervention, 1-month post-intervention and 3-months post-intervention
Secondary outcomes:
measure: pregnancy outcomes
timeFrame: During the delivery of pregnant women, the relevant data of pregnancy outcome were collected by consulting medical records or telephone follow-up.
Other outcomes:
measure: Apgar score of newborn
timeFrame: Apgar score at 1 minute and 5 minutes after birth
Locations:
city: Qingdao
country: China
facility: Wenyao Geng
state: Shandong
Study officials:
References:
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):42-49. doi: 10.1016/j.ajogmf.2019.02.002. Epub 2019 Mar 5.
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.
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: 10.21037/apm-21-2115.
citation: 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 2022.
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. Online ahead of print.