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出境医 / 临床实验 / A Behavioral Intervention to Prevent Gestational Diabetes Mellitus (DIGITAL-G)

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

Study Description
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.

Study Design
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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
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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.
Outcome Measures
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.



Eligibility Criteria
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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.
Contacts and Locations

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

Locations
Layout table for location information
China, Beijing
Haidian Maternal&Child Health Hospital Recruiting
Beijing, Beijing, China
Contact: Xiaohong Liu, MD    +8618810918477    zhanglinxi99@163.com   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hong Tianpei, MD,PhD Department of Endocrinology and Metabolism, Peking University Third Hospital
Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE August 16, 2019
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Adherence of behavioral intervention during pregnancy [ Time Frame: up to 28 gestational weeks ]
    Participates 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.
  • Satisfaction of prenatal medical care; questionnaires [ Time Frame: up to 24-28 gestational weeks ]
    Participates' satisfaction of prenatal medical care will be evaluated with questionnaires.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Behavioral Intervention to Prevent Gestational Diabetes Mellitus
Official Title  ICMJE Diabetes Mellitus, Impaired Glucose Tolerance and Gestational Diabetes Mellitus Intervention Action-Leading Trial- Gestational Diabetes Mellitus Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diabetes, Gestational
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Lifestyle intervention with APP
  • No Intervention: Control group
    Pregnant women randomized to the control group only have regular prenatal care in their local hospitals.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2019) 		1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987412
Other Study ID Numbers  ICMJE DIGITAL-G-2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking University Third Hospital
Study Sponsor  ICMJE Peking University Third Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hong Tianpei, MD,PhD Department of Endocrinology and Metabolism, Peking University Third Hospital
PRS Account Peking University Third Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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