Gestational Diabetes MellitusNCT05421845
Prevention of Gestational Diabetes Mellitus With Lifestyle Intervention Among Women of Advanced Maternal Age.
A study testing mobile-based combining with hospital-based lifestyle interventions in people with Gestational Diabetes Mellitus, run by Peking University at 1 site in China.
Trial summary
This is a single-blind randomized controlled trial, aiming to evaluate the preventive effects of mobile-based combining with hospital-based lifestyle interventions on GDM among women with advanced maternal age. It will be conducted in Beijing, with a sample size of 346. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- mobile-based combining with hospital-based lifestyle interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteChina
- Study dates
- Jul 2022to 31 Dec 2023
- 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- local resident in Beijing
- Singleton pregnancy
- Aged ≥35 years
- Overweight or obesity (Body mass index is between 24 and 27.9 kg/m2 or ≥28 kg/m2)
- ≤12 weeks of gestation
- written informed consent is obtained
Who cannot join
- Diagnosed with type 1 or type 2 diabetes before pregnancy
- Diagnosed with GDM or impaired glucose tolerance at enrollment
- use of medication that influences glucose metabolism currently, such as metformin, etc.
- multiple pregnancy
- current substance abuse
- unable to exercise due to physical disability
- diagnosed severe psychiatric disorder
- Other conditions not suitable for intervention as judged by physicians
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality
Yubo Zhou, PhD, 86-10-188 1053 3987, zhouyubo@bjmu.edu.cn
About this study
Official title: Prevention of Gestational Diabetes Mellitus With Mobile- and Hospital-based Lifestyle Intervention Among Women of Advanced Maternal Age: a Randomized Controlled Study.
This is a single-blind randomized controlled trial, aiming to evaluate the preventive effects of mobile-based combining with hospital-based lifestyle interventions on GDM among women with advanced maternal age. It will be conducted in Beijing, with a sample size of 346. All eligible pregnant women will be randomly assigned to either the intervention or control group, and followed up to delivery.
Read the detailed description
After the adjustment of fertility policy in China, the prevalence of advanced maternal age (AMA) has become a crucial issue in maternal health care. AMA can greatly increase the risk of gestational diabetes mellitus (GDM) during pregnancy. However, there is still a lack of high-quality evidence on GDM preventive interventions for AMA pregnancy in China.
In this randomized study, the investigators aim to examine whether mobile-based combining with hospital-based lifestyle interventions have preventive effects on GDM in AMA pregnancies. The investigators will enroll a total of 346 singleton pregnant women in Peking University First Hospital and randomly assign them to either the intervention or control group. Information of maternal characteristics will be obtained at recruitment. At each prenatal visit, weight and blood pressure of all participants will be measured. For each participant, fasting venous blood samples will be collected at <14 weeks of gestation, 24-28 weeks of gestation and pre-labor, and respectively assayed for fasting plasma glucose, glycated hemoglobin. The primary outcome is the incidence of GDM. The secondary outcomes include maternal glycated hemoglobin level, maternal fasting plasma glucose level, maternal complications, pregnancy outcomes, etc.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- mobile-based combining with hospital-based lifestyle interventions
- Keywords
- advanced maternal age, gestational diabetes mellitus, lifestyle intervention, randomized controlled study
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile-based combining with hospital-based lifestyle interventionsBehavioural
The same as that stated in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention group | Experimental | Participants will be given mobile- and hospital-based lifestyle interventions. The mobile-based interventions including dietary guidance, exercise supervision and weight monitoring will be conducted by trained physicians through WeChat group on cell phone every 1 to 2 weeks. Participants need to report their physical activity and weight information every week through WeChat group. Hospital-based intervention is a ≥5 minutes one-to-one and face-to-face personalized lifestyle counselling leading by a trained physician every 4 weeks during <14 weeks of gestation, every 2 weeks during 14-28 weeks of gestation, and once a week during ≥28 weeks of gestation. Participants' dietary information will be collected for any 3 consecutive days chosen by participants during 12-14 weeks of gestation, 24-28 weeks of gestation and >36 weeks of gestation respectively using a food frequency questionnaire. Receives: Behavioral: mobile-based combining with hospital-based lifestyle interventions |
| control group | No intervention | Participants in control group will be managed in accordance with the standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of gestational diabetes mellitus
diagnosed by the oral glucose tolerance test
Measured: from 24 weeks of gestation to delivery.
Secondary outcomes (14)
maternal glycated hemoglobin level
obtained from fasting venous blood samples
Measured: at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
maternal fasting plasma glucose level
obtained from fasting venous blood samples
Measured: at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
maternal gestational weight gain
in kilograms
Measured: from recruitment to delivery
incidence of gestational hypertension
defined as a systolic blood pressure of ≥140 mmHg or diastolic blood pressure of ≥90 mmHg occurring after 20 weeks of gestation
Measured: from 20 weeks of gestation to delivery.
incidence of pre-eclampsia
defined as a systolic blood pressure of ≥140 mmHg or diastolic blood pressure of ≥90 mmHg occurring after 20 weeks of gestation in a previously normotensive woman combined with new-onset proteinuria of ≥0.3 g/24 h
Measured: from 20 weeks of gestation to delivery.
delivery mode
such as vaginal delivery, ceseran delivery, operative vaginal delivery
Measured: at delivery
birthweight
in original scale (g) or z-score
Measured: at delivery
Macrosomia
defined as a birth weight of > 4000 g
Measured: at delivery
low birthweight
defined as a birth weight of < 2500 g
Measured: at delivery
Gestational age at birth
in weeks
Measured: at delivery
Premature delivery
less than 37 weeks' gestational age
Measured: at delivery
Apgar score
Apagr score
Measured: 1 min and 5 min
maternal dietary information
food species and servings
Measured: any 3 consecutive days chosen randomly by participants during 12-14 weeks of gestation, 24~28 weeks of gestation and >36 weeks of gestation respectively
maternal physical activity information
type of physical activity and time spend on it weekly
Measured: every 1-2 weeks during enrollment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study startJul 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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 Peking 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
- Outcomes assessor
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
- Investigators
- Yumei Wei, PhD, Principal investigator, Peking University First HospitalYubo Zhou, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421845
- Sponsor's protocol ID
- BMU2022MX022
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Gestational Diabetes Mellitus With Mobile- and Hospital-based Lifestyle Intervention Among Women of Advanced Maternal Age: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05421845
- Acronym / sponsor ID
- BMU2022MX022
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- advanced maternal age, gestational diabetes mellitus, lifestyle intervention, randomized controlled study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking University First Hospital
- Study start
- Jul 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Jun 2022 (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.
This is a single-blind randomized controlled trial, aiming to evaluate the preventive effects of mobile-based combining with hospital-based lifestyle interventions on GDM among women with advanced maternal age. It will be conducted in Beijing, with a sample size of 346. All eligible pregnant women will be randomly assigned to either the intervention or control group, and followed up to delivery.
Detailed description
After the adjustment of fertility policy in China, the prevalence of advanced maternal age (AMA) has become a crucial issue in maternal health care. AMA can greatly increase the risk of gestational diabetes mellitus (GDM) during pregnancy. However, there is still a lack of high-quality evidence on GDM preventive interventions for AMA pregnancy in China.
In this randomized study, the investigators aim to examine whether mobile-based combining with hospital-based lifestyle interventions have preventive effects on GDM in AMA pregnancies. The investigators will enroll a total of 346 singleton pregnant women in Peking University First Hospital and randomly assign them to either the intervention or control group. Information of maternal characteristics will be obtained at recruitment. At each prenatal visit, weight and blood pressure of all participants will be measured. For each participant, fasting venous blood samples will be collected at <14 weeks of gestation, 24-28 weeks of gestation and pre-labor, and respectively assayed for fasting plasma glucose, glycated hemoglobin. The primary outcome is the incidence of GDM. The secondary outcomes include maternal glycated hemoglobin level, maternal fasting plasma glucose level, maternal complications, pregnancy outcomes, etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention group | Experimental | Behavioral: mobile-based combining with hospital-based lifestyle interventionsParticipants will be given mobile- and hospital-based lifestyle interventions. The mobile-based interventions including dietary guidance, exercise supervision and weight monitoring will be conducted by trained physicians through WeChat group on cell phone every 1 to 2 weeks. Participants need to report their physical activity and weight information every week through WeChat group. Hospital-based intervention is a ≥5 minutes one-to-one and face-to-face personalized lifestyle counselling leading by a trained physician every 4 weeks during <14 weeks of gestation, every 2 weeks during 14-28 weeks of gestation, and once a week during ≥28 weeks of gestation. Participants' dietary information will be collected for any 3 consecutive days chosen by participants during 12-14 weeks of gestation, 24-28 weeks of gestation and >36 weeks of gestation respectively using a food frequency questionnaire. |
| control group | No intervention | –Participants in control group will be managed in accordance with the standard practice. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- local resident in Beijing
- Singleton pregnancy
- Aged ≥35 years
- Overweight or obesity (Body mass index is between 24 and 27.9 kg/m2 or ≥28 kg/m2)
- ≤12 weeks of gestation
Key exclusion criteria (8 listed)
- Diagnosed with type 1 or type 2 diabetes before pregnancy
- Diagnosed with GDM or impaired glucose tolerance at enrollment
- use of medication that influences glucose metabolism currently, such as metformin, etc.
- multiple pregnancy
- current substance abuse
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 |
|---|---|---|
| mobile-based combining with hospital-based lifestyle interventionsThe same as that stated in arm descriptions. | Behavioural | Lifestyle intervention group |
Primary outcome
incidence of gestational diabetes mellitus
Time frame: from 24 weeks of gestation to delivery.
diagnosed by the oral glucose tolerance test
14 secondary outcomes
maternal glycated hemoglobin level
Time frame: at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
maternal fasting plasma glucose level
Time frame: at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
maternal gestational weight gain
Time frame: from recruitment to delivery
incidence of gestational hypertension
Time frame: from 20 weeks of gestation to delivery.
incidence of pre-eclampsia
Time frame: from 20 weeks of gestation to delivery.
delivery mode
Time frame: at delivery
birthweight
Time frame: at delivery
Macrosomia
Time frame: at delivery
low birthweight
Time frame: at delivery
Gestational age at birth
Time frame: at delivery
Premature delivery
Time frame: at delivery
Apgar score
Time frame: 1 min and 5 min
maternal dietary information
Time frame: any 3 consecutive days chosen randomly by participants during 12-14 weeks of gestation, 24~28 weeks of gestation and >36 weeks of gestation respectively
maternal physical activity information
Time frame: every 1-2 weeks during enrollment to delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: Yes. The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared
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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.
Yumei Wei, PhD principal investigator
Peking University First Hospital
Yubo Zhou principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile-based combining with hospital-based lifestyle interventions in people with Gestational Diabetes Mellitus, run by Peking 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 6 inclusion and 8 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 16 Jun 2022. 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 Yubo Zhou, PhD (86-10-188 1053 3987, zhouyubo@bjmu.edu.cn), 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 24 weeks of gestation to delivery.). 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 16 Jun 2022.