Gestational Diabetes Mellitus in PregnancyNCT05613920
Dietary Management of Gestational Diabetes Mellitus
A study testing diet management program based on the nudge strategy in people with Gestational Diabetes Mellitus in Pregnancy and Diet, run by Qingdao University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Diet, Healthy
- What is being tested?
- diet management program based on the nudge strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2022to Feb 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Meeting the diagnostic criteria related to GDM by oral glucose tolerance test (OGTT), etc.
- Singleton pregnancy
- Age ≥ 18 years
- Gestational weeks 24-28
- 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
Show all 10Show fewer
- Lost to the study due to unforeseen circumstances
- Voluntarily requested to withdraw from the study
- Did not take the intervention as required by the relevant requirements
- Condition was unstable and could not continue to cooperate.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Wenyao Geng
Qingdao, Shandong, 266071
Heng Liu, 86-0532-82991205, hengliu@qdu.edu.cn
Heng Liu, 86-0532-82991205, hengliu516@163.com
About this study
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.
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Diet, Healthy
- Being tested
- diet management program based on the nudge strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet management program based on the nudge strategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| diet management program based on the nudge strategy | Experimental | The intervention group will receive a diet management program based on the nudge strategy Receives: Behavioral: diet management program based on the nudge strategy |
| routine dietary management program | No intervention | The control group will receive a routine dietary management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention, 1-month post-intervention and 3-months post-intervention
Secondary outcomes (1)
pregnancy outcomes
Number of Participants with Premature, Cesarean delivery, Gestational hypertension, Giant baby, Fetal intrauterine distress
Measured: During the delivery of pregnant women, the relevant data of pregnancy outcome were collected by consulting medical records or telephone follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start10 Nov 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenyao Geng, Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613920
- Sponsor's protocol ID
- QDU-HEC-2021149
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Decide not to share participant data from the perspective of protecting participant privacy
Publications
Phillips JK, Skelly JM, Roberts LM, Bernstein IM, Higgins ST. Combined financial incentives and behavioral weight management to enhance adherence with gestational weight gain guidelines: a randomized controlled trial. Am J Obstet Gynecol MFM. 2019 Mar;1(1):42-49. doi: 10.1016/j.ajogmf.2019.02.002. Epub 2019 Mar 5.
PubMed 33319756Xu S, Yu Q, Mi J, Li H. Clinical efficacy of nutritional diet therapy on gestational diabetes mellitus. Am J Transl Res. 2022 May 15;14(5):3488-3493. eCollection 2022.
PubMed 35702079Zhou S, Wang L, Chen J, Liu L, Wu X. Effects of individual dietary intervention on blood glucose level and pregnancy outcomes in patients with gestational diabetes mellitus: a retrospective cohort study. Ann Palliat Med. 2021 Sep;10(9):9692-9701. doi: 10.21037/apm-21-2115.
PubMed 34628895Chen L, Zhang W, Fu A, Zhou L, Zhang S. Effects of WeChat platform-based nursing intervention on disease severity and maternal and infant outcomes of patients with gestational diabetes mellitus. Am J Transl Res. 2022 May 15;14(5):3143-3153. eCollection 2022.
PubMed 35702129Kapur K, Kapur A, Hod M. Nutrition Management of Gestational Diabetes Mellitus. Ann Nutr Metab. 2021 Feb 1:1-13. doi: 10.1159/000509900. Online ahead of print.
PubMed 33524988
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Management of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05613920
- Acronym / sponsor ID
- QDU-HEC-2021149
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 14 Nov 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diet management program based on the nudge strategy | Experimental | Behavioral: diet management program based on the nudge strategyThe intervention group will receive a diet management program based on the nudge strategy |
| routine dietary management program | No intervention | –The control group will receive a routine dietary management program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Meeting the diagnostic criteria related to GDM by oral glucose tolerance test (OGTT), etc.
- Singleton pregnancy
- Age ≥ 18 years
- Gestational weeks 24-28
- Informed consent for voluntary participation in this study Exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| diet management program based on the nudge strategyThe 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. | Behavioural | diet management program based on the nudge strategy |
Primary outcome
Changes in blood glucose levels over time
Time frame: Pre-intervention, 1-month post-intervention and 3-months post-intervention
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.
1 secondary outcome
pregnancy outcomes
Time frame: During the delivery of pregnant women, the relevant data of pregnancy outcome were collected by consulting medical records or telephone follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Results publication: PubMed 33319756Phillips JK, Skelly JM, Roberts LM, Bernstein IM, Higgins ST. Combined financial incentives and behavioral weight management to enhance adherence with gestational weight gain guidelines: a randomized controlled trial. Am J Obstet Gynecol MFM. 2019 Mar;1(1):42-49. doi: 10.1016/j.ajogmf.2019.02.002. Epub 2019 Mar 5.
- Results publication: PubMed 35702079Xu S, Yu Q, Mi J, Li H. Clinical efficacy of nutritional diet therapy on gestational diabetes mellitus. Am J Transl Res. 2022 May 15;14(5):3488-3493. eCollection 2022.
- Results publication: PubMed 34628895Zhou S, Wang L, Chen J, Liu L, Wu X. Effects of individual dietary intervention on blood glucose level and pregnancy outcomes in patients with gestational diabetes mellitus: a retrospective cohort study. Ann Palliat Med. 2021 Sep;10(9):9692-9701. doi: 10.21037/apm-21-2115.
- Results publication: PubMed 35702129Chen L, Zhang W, Fu A, Zhou L, Zhang S. Effects of WeChat platform-based nursing intervention on disease severity and maternal and infant outcomes of patients with gestational diabetes mellitus. Am J Transl Res. 2022 May 15;14(5):3143-3153. eCollection 2022.
- Results publication: PubMed 33524988Kapur K, Kapur A, Hod M. Nutrition Management of Gestational Diabetes Mellitus. Ann Nutr Metab. 2021 Feb 1:1-13. doi: 10.1159/000509900. Online ahead of print.
- Individual participant dataSharing planned: No. Decide not to share participant data from the perspective of protecting participant privacy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet management program based on the nudge strategy in people with Gestational Diabetes Mellitus in Pregnancy and Diet, run by Qingdao 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 10 inclusion and 0 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 14 Nov 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 Heng Liu (86-0532-82991205, hengliu@qdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood glucose levels over time (time frame: Pre-intervention, 1-month post-intervention and 3-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05613920, which also lists 5 linked publications.
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 14 Nov 2022.