Dietary Management of Gestational Diabetes Mellitus

Qingdao University

Status: Not yet enrolling

Conditions: Healthy; Gestational Diabetes Mellitus in Pregnancy; Diet

Treatments: Behavioral: diet management program based on the nudge strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05613920

QDU-HEC-2021149

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

diet management program based on the nudge strategy

Experimental group

Description:

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

Treatment:

Behavioral: diet management program based on the nudge strategy

routine dietary management program

No Intervention group

Description:

The control group will receive a routine dietary management program