Back to resultsDietary Management of Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy, Diet, Healthy
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
diet management program based on the nudge strategy
Sponsored by
About this trial
This is an interventional supportive care trial for Gestational Diabetes Mellitus in Pregnancy
Eligibility Criteria
Inclusion criteria Meeting the diagnostic criteria related to GDM by oral glucose tolerance test (OGTT), etc. Singleton pregnancy Age ≥ 18 years Gestational weeks 24-28 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 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.
Sites / Locations
- Wenyao Geng
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
diet management program based on the nudge strategy
routine dietary management program
Arm Description
The intervention group will receive a diet management program based on the nudge strategy
The control group will receive a routine dietary management program
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
pregnancy outcomes
Number of Participants with Premature, Cesarean delivery, Gestational hypertension, Giant baby, Fetal intrauterine distress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05613920
Brief Title
Dietary Management of Gestational Diabetes Mellitus
Official Title
Dietary Management of Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 10, 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qingdao University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy, Diet, Healthy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diet management program based on the nudge strategy
Arm Type
Experimental
Arm Description
The intervention group will receive a diet management program based on the nudge strategy
Arm Title
routine dietary management program
Arm Type
No Intervention
Arm Description
The control group will receive a routine dietary management program
Intervention Type
Behavioral
Intervention Name(s)
diet management program based on the nudge strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in blood glucose levels over time
Description
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.
Time Frame
Pre-intervention, 1-month post-intervention and 3-months post-intervention
Secondary Outcome Measure Information:
Title
pregnancy outcomes
Description
Number of Participants with Premature, Cesarean delivery, Gestational hypertension, Giant baby, Fetal intrauterine distress
Time Frame
During the delivery of pregnant women, the relevant data of pregnancy outcome were collected by consulting medical records or telephone follow-up.
Other Pre-specified Outcome Measures:
Title
Apgar score of newborn
Description
Apgar score at 1 minute and 5 minutes after birth in both groups
Time Frame
Apgar score at 1 minute and 5 minutes after birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Meeting the diagnostic criteria related to GDM by oral glucose tolerance test (OGTT), etc.
Singleton pregnancy
Age ≥ 18 years
Gestational weeks 24-28
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heng Liu
Phone
86-0532-82991205
Email
hengliu@qdu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Heng Liu
Phone
86-0532-82991205
Email
hengliu516@163.com
Facility Information:
Facility Name
Wenyao Geng
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heng Liu
Phone
86-0532-82991205
Email
hengliu@qdu.edu.cn
First Name & Middle Initial & Last Name & Degree
Heng Liu
Phone
86-0532-82991205
Email
hengliu516@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Decide not to share participant data from the perspective of protecting participant privacy
Citations:
PubMed Identifier
33319756
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.
Results Reference
result
PubMed Identifier
35702079
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.
Results Reference
result
PubMed Identifier
34628895
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.
Results Reference
result
PubMed Identifier
35702129
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.
Results Reference
result
PubMed Identifier
33524988
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.
Results Reference
result
Learn more about this trial
Dietary Management of Gestational Diabetes Mellitus
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