Gestational Diabetes MellitusNCT04989634
Effects of Dietary and Weight Management on Pregnancy Outcomes in Mobile Medical Platform
A study testing Intensive dietary and weight management in people with Gestational Diabetes Mellitus and Hypertensive Disorder of Pregnancy, run by Capital Medical University at 1 site in China.
Trial summary
With the opening up of the two-child policy , the composition of pregnant women in China has changed significantly . The proportion of high-risk pregnant women in the elderly has increased significantly , and the risk of adverse pregnancy outcomes has also increased . Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Hypertensive Disorder of Pregnancy
- What is being tested?
- Intensive dietary and weight management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Regular check-ups in our hospital
- 18-44 years old
- 8-12 gestational weeks
Who cannot join
- Patients with incomplete medical records
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, 100026
Guanghui Li, MD,PHD, 86-10-52273110, liguanghui2007@163.com
About this study
With the opening up of the two-child policy , the composition of pregnant women in China has changed significantly . The proportion of high-risk pregnant women in the elderly has increased significantly , and the risk of adverse pregnancy outcomes has also increased . Among them , gestational diabetes mellitus ( GDM ) is the most common complication during pregnancy . The incidence of GDM in China is as high as 18 % due to the economic growth , lifestyle changes and dietary habits . GDM not only threatens perinatal maternal and child health , but also increases the risk of offspring insulin resistance , obesity and metabolic diseases in adulthood . But it is still lack of experience on intervening and managing them effectively. Therefore , on the basis of previous studies , this study intends to explore the effects of intensive diet and exercise intervention by obstetricians and nutritionists on pregnancy weight gain , pregnancy outcome , glucose and lipid metabolism and postpartum weight retention under the mobile medical platform through a large sample cluster intervention test in the real world. In order to supervise and improve the compliance of the intervention subjects and realize the ultimate change of their behaviors, this study intends to use the APP software, the mobile medical technology, to monitor and evaluate diet , exercise and weight. Through the above research , it aims to improve the current management schemes of diet and weight during pregnancy , not only helps to optimize and improve the quality of perinatal health care , but also prevents the adult chronic diseases from the fetal period. This research has important theoretical and practical value .
Read the detailed description
This is a cluster intervention study. A randomized controlled trial in pregnant women will be initiated at 8-12 weeks of gestation util delivery. Pregnant women who received routine antenatal examination in Beijing Obstetrics and Gynecology Hospital will be divided into two groups . One group contained 1000 cases as the control group , and the other group contained 1000 cases as a whole . The intervention contents included health education , nutritional analysis and individualized dietary guidance combined with mobile medical treatment and face-to-face teaching during the early , middle and late pregnancy stages. The primary outcome will be the incidence of GDM and the secondary outcome will be the incidence of hypertensive disorders of pregnancy , cesarean section , premature delivery , macrosomia, large for gestational age and so on.
- Being tested
- Intensive dietary and weight management, Standard care
- Medical subject headings
- Diabetes, Gestational, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive dietary and weight managementBehavioural
health education , nutritional analysis and individualized dietary guidance
Standard careBehavioural
Standard prenatal education on diet, nutrition and physical activity
| Study group | Role | What they receive |
|---|---|---|
| standard care | Active comparator | In the early pregnancy ( 8-12 weeks of pregnancy ) , a group education on dietary weight management will be carried out according to the current medical system and the regulations of our hospital , followed by routine prenatal examination . According to the corresponding diagnosis and treatment guidelines, examinations and follow-up interventions will be carried out if the metabolic diseases are occurred during pregnancy. Receives: Behavioral: Standard care |
| dietary and weight management | Experimental | A randomized controlled trial in pregnant women will be initiated at 8-12 weeks of gestation util delivery. The intervention contents included health education , nutritional analysis and individualized dietary guidance combined with mobile medical treatment and face-to-face teaching during the early , middle and late pregnancy stages. Receives: Behavioral: Intensive dietary and weight management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gestational diabetes mellitus
Measured: From enrollment to 24-28 weeks of gestation
Secondary outcomes (3)
Incidence of gestational hypertension
Measured: From date of randomization until the date of delivery, assessed up to 9 months
Incidence of cesarean section
Measured: From date of randomization until the date of delivery, assessed up to 9 months
Incidence of premature birth
Measured: From date of randomization until the date of delivery, assessed up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Jul 2019
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guanghui Li, Capital Medical University
- Investigators
- Guanghui Li, MD, PhD, Principal investigator, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989634
- Sponsor's protocol ID
- 2019-KY-036-02
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary and Weight Management on Pregnancy Outcomes in Mobile Medical Platform
- ClinicalTrials.gov ID
- NCT04989634
- Acronym / sponsor ID
- 2019-KY-036-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the opening up of the two-child policy , the composition of pregnant women in China has changed significantly . The proportion of high-risk pregnant women in the elderly has increased significantly , and the risk of adverse pregnancy outcomes has also increased . Among them , gestational diabetes mellitus ( GDM ) is the most common complication during pregnancy . The incidence of GDM in China is as high as 18 % due to the economic growth , lifestyle changes and dietary habits . GDM not only threatens perinatal maternal and child health , but also increases the risk of offspring insulin resistance , obesity and metabolic diseases in adulthood . But it is still lack of experience on intervening and managing them effectively. Therefore , on the basis of previous studies , this study intends to explore the effects of intensive diet and exercise intervention by obstetricians and nutritionists on pregnancy weight gain , pregnancy outcome , glucose and lipid metabolism and postpartum weight retention under the mobile medical platform through a large sample cluster intervention test in the real world. In order to supervise and improve the compliance of the intervention subjects and realize the ultimate change of their behaviors, this study intends to use the APP software, the mobile medical technology, to monitor and evaluate diet , exercise and weight. Through the above research , it aims to improve the current management schemes of diet and weight during pregnancy , not only helps to optimize and improve the quality of perinatal health care , but also prevents the adult chronic diseases from the fetal period. This research has important theoretical and practical value .
Detailed description
This is a cluster intervention study. A randomized controlled trial in pregnant women will be initiated at 8-12 weeks of gestation util delivery. Pregnant women who received routine antenatal examination in Beijing Obstetrics and Gynecology Hospital will be divided into two groups . One group contained 1000 cases as the control group , and the other group contained 1000 cases as a whole . The intervention contents included health education , nutritional analysis and individualized dietary guidance combined with mobile medical treatment and face-to-face teaching during the early , middle and late pregnancy stages. The primary outcome will be the incidence of GDM and the secondary outcome will be the incidence of hypertensive disorders of pregnancy , cesarean section , premature delivery , macrosomia, large for gestational age and so on.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | Active comparator | Behavioral: Standard careIn the early pregnancy ( 8-12 weeks of pregnancy ) , a group education on dietary weight management will be carried out according to the current medical system and the regulations of our hospital , followed by routine prenatal examination . According to the corresponding diagnosis and treatment guidelines, examinations and follow-up interventions will be carried out if the metabolic diseases are occurred during pregnancy. |
| dietary and weight management | Experimental | Behavioral: Intensive dietary and weight managementA randomized controlled trial in pregnant women will be initiated at 8-12 weeks of gestation util delivery. The intervention contents included health education , nutritional analysis and individualized dietary guidance combined with mobile medical treatment and face-to-face teaching during the early , middle and late pregnancy stages. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Regular check-ups in our hospital
- 18-44 years old
- 8-12 gestational weeks
Key exclusion criteria (1 listed)
- Patients with incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive dietary and weight managementhealth education , nutritional analysis and individualized dietary guidance | Behavioural | dietary and weight management |
| Standard careStandard prenatal education on diet, nutrition and physical activity | Behavioural | standard care |
Primary outcome
Incidence of gestational diabetes mellitus
Time frame: From enrollment to 24-28 weeks of gestation
3 secondary outcomes
Incidence of gestational hypertension
Time frame: From date of randomization until the date of delivery, assessed up to 9 months
Incidence of cesarean section
Time frame: From date of randomization until the date of delivery, assessed up to 9 months
Incidence of premature birth
Time frame: From date of randomization until the date of delivery, assessed up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guanghui Li, MD, PhD principal investigator
Beijing Obstetrics and Gynecology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive dietary and weight management in people with Gestational Diabetes Mellitus and Hypertensive Disorder of Pregnancy, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guanghui Li, MD, PhD (008613124728821, liguanghui2007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gestational diabetes mellitus (time frame: From enrollment to 24-28 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.