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A Behavioral Intervention to Prevent Gestational Diabetes Mellitus (DIGITAL-G)

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ClinicalTrials.gov Identifier: NCT03987412
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Brief Summary:

Gestational diabetes mellitus (GDM) increases the risk of adverse pregnancy outcome and developing type 2 diabetes after delivery. It is well recognized that behavioral intervention is effective in preventing type 2 diabetes in high risk population. Recently, some studies showed that exercise, dietary and weight control reduced the risk of developing GDM in obese/over weight women or in women with GDM history. With the increasing use of smartphones, mobile applications (APPs) can be applied in the education and management of chronic diseases, including diabetes. Therefore, the investigators will conduct a multi-centered, two-armed, open-labeled, randomized controlled trial to evaluate whether early lifestyle intervention with a mobile APP can prevent the occurrence of GDM in pregnant women who are at high risk of this disease.

The investigators hypothesis that behavioral intervention from the first trimester of pregnancy with mobile APP that incorporates nutrition, exercise and phycological support will:

  1. Reduce the risk of developing GDM in pregnant women with risks of GDM.
  2. Improve the pregnant women's adherence of behavioral intervention and their satisfaction of prenatal medical care.

Condition or disease Intervention/treatment Phase
Diabetes, Gestational Behavioral: Lifestyle intervention with APP Not Applicable

Detailed Description:

Participates will be recruited from five research centers in the mainland of China. Pregnant women will be screened for risks of GDM at their first visit for prenatal care during their first trimester (less than 12 gestational weeks). Obstetricians will introduce the study to women who have one or more risk factors.

Women who meet the eligibility criteria and who are willing to provide informed consent will be enrolled and randomized to behavioral intervention group and control group. Women in the behavioral intervention group will be educated about the risks of GDM, and then applied with a mobile APP that provides nutrition, exercise and phycological support starting from their first trimester. This behavioral support will be modified individually and continuously according to the pregnant women's feedback of their daily performance through the APP. Both groups will have regular prenatal care.

During 24-28 gestational weeks, GDM will be diagnosed by a 75g oral glucose tolerance test (OGTT) according to the new World Health Organization criteria as fasting glucose level in fasting whole blood ≥5.1mmol/L, or 1-hour value ≥10.0mmol/l, or 2-hour value ≥8.5mmol/L. Investigators will compare the GDM risk in the two groups to evaluate whether behavioral intervention with mobile APP can reduce the risk of GDM in Chinese pregnant women who are at high risk of GDM. Participants' adherence with the behavioral intervention will be evaluated by analyzing the data collected by the APP, and participants' satisfaction of the prenatal care will be evaluated with questionnaires during 24-28 gestational weeks. Intervention with the APP will be stopped in the third trimester. All the participates will receive standard medical management until they give birth.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Diabetes Mellitus, Impaired Glucose Tolerance and Gestational Diabetes Mellitus Intervention Action-Leading Trial- Gestational Diabetes Mellitus Study
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral intervention
Pregnant women randomized to the behavioral intervention group will recieve a face-to-face education about the risks of GDM at their local rearch centers. Then they will be provided with a mobile APP incorporating nutrition, exercise and phycological support. They will also have regular prenatal care in their local hospitals.
Behavioral: Lifestyle intervention with APP
The face to face education class will be conducted by an obstetrician, an endocrinologist and a nutritionist together. Then the lifestyle intervention will be launched by an APP that installed in participants' private mobile phones, including nutrition, exercise and phycological support. Nutrition guidance is conducted according to the Chinese Dietary Guide, Chinese and international guidelines of gestation diabetes management. Exercise support is given based on the Guidelines for National Fitness of China, Chinese and international guidelines of gestation diabetes. Phycological support is given by sending education articles on mental health. Participants are encouraged to update data about their diet, exercise and body weight through the APP, and based on the data investigators will individualize the suggestions.

No Intervention: Control group
Pregnant women randomized to the control group only have regular prenatal care in their local hospitals.



Primary Outcome Measures :
  1. The risk of gestational diabetes mellitus (GDM) [ Time Frame: 24-28 gestational weeks ]
    GDM will be diagnosed by a 75g OGTT according to the World Health Organization criteria as fasting plasma glucose level ≥5.1 mmol/L, or 1-hour value ≥10.0mmol/l, or 2-hour value ≥8.5mmol/L. Investigators will calculate the occurrence rate of GDM to represent the risk of GDM.


Secondary Outcome Measures :
  1. Adherence of behavioral intervention during pregnancy [ Time Frame: up to 28 gestational weeks ]
    Participants will be encouraged to update their data about their diet, exercise and body weight. The frequency of their update and feedback data will be used to evaluate the adherence of behavioral intervention.

  2. Satisfaction of prenatal medical care; questionnaires [ Time Frame: up to 24-28 gestational weeks ]

    Participants' satisfaction of prenatal medical care will be evaluated with questionnaires. The questionnaire was designed by the investigators according to references (Stoyanov SR. JMIR Mhealth Uhealth, 2015, 1(3): e27. et al) named the " Satisfaction Questionnaire of Behavioral Intervention to Prevent GDM". It includes 7 subscales. The final form of each subscale is a five-point scale (5 Strongly agree / 4 agree / 3 don't know / 2 disagree / 1 strongly disagree, modified from Likert Scale) which is used to allow the participants to express how much they agree or disagree with the satisfaction statement.

    1. Convenience and feasibility of behavioral intervention
    2. Effects of behavioral intervention
    3. Behavioral intervention do not have adverse reactions
    4. Ease use of APP
    5. Good engagement of APP
    6. High information quality of APP
    7. The investigators serve well

    Summarize each scale to compute a total score. Higher values represent a better outcome.




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chinese pregnant women aged between 30 and 45 years who have one or more risk factors when they are on their first prenatal care visit. The risk factors are listed as following:

    1. Fasting plasma glucose level ≥ 4.4 mmol/l.
    2. Body mass index ≥ 24 kg/m^2
    3. Systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.
    4. First-degree family history of diabetes
    5. History of GDM
    6. History of polycystic ovary syndrome.
  • Willing to keep reading the education articles and supporting materials that delivered by the mobile APP.
  • Willing to provide informed consent.

Exclusion Criteria:

  • First prenatal care visit later than 12 gestational weeks
  • Fasting plasma glucose level value ≥5.6 mmol/l, or glycated hemoglobin value ≥ 5.6%.
  • Continuous use of antidiabetic medicine for 7 days or more within the current 3 months
  • Spontaneous abortion twice or more
  • Body weight loss for 10% or more within the current 3 months
  • History of other diseases including but not limited to:

    1. Arteriosclerotic cardiovascular disease, heart failure or stroke
    2. Systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥90 mmHg.
    3. Hematological system diseases. For anemia patients, hemoglobin ≥90g/l is acceptable.
    4. Renal dysfunction or liver dysfunction
    5. Rheumatic diseases, currently receiving glucocorticoids or other immunosuppressors
    6. Serious diseases of respiratory system with current use of glucocorticoids.
    7. Diseases of endocrine system. But it is acceptable that the hypothyroidism has been controlled with levothyroxine.
  • Other conditions that investigators consider inappropriate for this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987412


Contacts
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Contact: Hong Tianpei, MD,PhD +8613683265725 ext +8615611908212 tpho66@bjmu.edu.cn
Contact: Yang Jin, PhD +8615810298367 yangjin@bjmu.edu.cn

Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Hong Tianpei, MD,PhD Department of Endocrinology and Metabolism, Peking University Third Hospital

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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03987412     History of Changes
Other Study ID Numbers: DIGITAL-G-2019
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking University Third Hospital:
Behavioral intervention
First trimester
Gestational diabetes mellitus

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications