Dietary Management of Gestational Diabetes Mellitus

• Sponsor: Qingdao University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05613920
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.7
• Patients Per Site Per Month: 17.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Mellitus in Pregnancy; Diet; Healthy	Behavioral: diet management program based on the nudge strategy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Dietary Management of Gestational Diabetes Mellitus
• Anticipated Study Start Date: Nov 10, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: diet management program based on the nudge strategy The intervention group will receive a diet management program based on the nudge strategy	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.
No Intervention: routine dietary management program The control group will receive a routine dietary management program

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

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.]

   Number of Participants with Premature, Cesarean delivery, Gestational hypertension, Giant baby, Fetal intrauterine distress

Other Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wenyao Geng	Qingdao	Shandong	China	266071

Sponsors and Collaborators

• Qingdao University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Nov 23, 2021

More Information

Publications

None provided.

• Responsible Party: Wenyao Geng, Principal Investigator, Qingdao University
• ClinicalTrials.gov Identifier: NCT05613920
• Other Study ID Numbers: QDU-HEC-2021149
• First Posted: Nov 14, 2022
• Last Update Posted: Nov 14, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus

Study Results

No Results Posted as of Nov 14, 2022