Dietary Management of Gestational Diabetes Mellitus

NCT05613920 | Unknown

• 1 other identifier: QDU-HEC-2021149
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Diet; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• pregnancy outcomes

  During the delivery of pregnant women, the relevant data of pregnancy outcome were collected by consulting medical records or telephone follow-up.

Other Outcomes (1)

• Apgar score of newborn

  Apgar score at 1 minute and 5 minutes after birth

Study Arms (2)

diet management program based on the nudge strategy

EXPERIMENTAL

The intervention group will receive a diet management program based on the nudge strategy

Behavioral: diet management program based on the nudge strategy

routine dietary management program

NO INTERVENTION

The control group will receive a routine dietary management program

Interventions

diet management program based on the nudge strategy BEHAVIORAL

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.

diet management program based on the nudge strategy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meeting the diagnostic criteria related to GDM by oral glucose tolerance test (OGTT), etc.
• Singleton pregnancy
• Age ≥ 18 years
• Gestational weeks 24-28

You may not qualify if:

• 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
• Lost to the study due to unforeseen circumstances
• Voluntarily requested to withdraw from the study
• Did not take the intervention as required by the relevant requirements
• Condition was unstable and could not continue to cooperate.

Sponsors & Collaborators

• Qingdao University: lead

Study Sites (1)

Wenyao Geng

Qingdao, Shandong, 266071, China

Location

Related Publications (5)

• 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.

  PMID: 33319756 RESULT

• 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.

  PMID: 35702079 RESULT

• 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.

  PMID: 34628895 RESULT

• 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.

  PMID: 35702129 RESULT

• 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.

  PMID: 33524988 RESULT

Central Study Contacts

Heng Liu

CONTACT

86-0532-82991205; hengliu@qdu.edu.cn

Heng Liu

CONTACT

86-0532-82991205; hengliu516@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 14, 2022
• Study Start: November 10, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)