Dietary Management of Gestational Diabetes Mellitus

Qingdao University48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Gestational Diabetes Mellitus in Pregnancy Diet Healthy

Interventions

diet management program based on the nudge strategyBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Pre-intervention, 1-month post-intervention and 3-months post-intervention

Secondary Outcomes

pregnancy outcomes

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.