Dietary Management of Gestational Diabetes Mellitus

NCT ID: NCT05613920

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus in Pregnancy Diet Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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diet management program based on the nudge strategy

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

Group Type EXPERIMENTAL

diet management program based on the nudge strategy

Intervention Type 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.

routine dietary management program

The control group will receive a routine dietary management program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Wenyao Geng

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wenyao Geng

Qingdao, Shandong, China

Site Status

Countries

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China

Central Contacts

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Heng Liu

Role: CONTACT

86-0532-82991205

Heng Liu

Role: CONTACT

86-0532-82991205

Facility Contacts

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Heng Liu

Role: primary

86-0532-82991205

Heng Liu

Role: backup

86-0532-82991205

References

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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.

Reference Type RESULT
PMID: 33319756 (View on PubMed)

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.

Reference Type RESULT
PMID: 35702079 (View on PubMed)

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.

Reference Type RESULT
PMID: 34628895 (View on PubMed)

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.

Reference Type RESULT
PMID: 35702129 (View on PubMed)

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.

Reference Type RESULT
PMID: 33524988 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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QDU-HEC-2021149

Identifier Type: -

Identifier Source: org_study_id

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