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Gestational Diabetes Mellitus (GDM)GDMNCT01554358

Tianjin Gestational Diabetes Prevention Program (TGDPP)

A study testing Lifestyle intervention in people with Gestational Diabetes Mellitus (GDM), run by Tianjin Women and Children's Health Center at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009 and their children have and continues to be randomly assigned to either the intervention group or the control group. Read more about this study

Who is it for?
Ages 20 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes Mellitus (GDM)
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,526 participants
Where
1 siteChina
Study dates
Aug 2009to Jul 2011
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 20 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 20-49 years
  • Women diagnosed with GDM between 2005 and 2009.
  • Inclusion Criteria for children: age 1-5 years at baseline survey.

Who cannot join

  • Age < 20 and ≥ 50 years
  • Newly diagnosed diabetes in the screening visit
  • The presence of any chronic diseases that could seriously reduce their life expectancy or their ability to participate in the trial
  • Unable or unwilling to give informed consent or communicate with study staff
  • Currently pregnant, or planning to become pregnant in the next four years

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Women's and Children's Health Center

    Tianjin, 30070

Other trials in China

About this study

Official title: Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP)

A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009 and their children have and continues to be randomly assigned to either the intervention group or the control group. A total of 83 women with prior GDM and newly diagnosed diabetes at baseline survey have the nine-month lifestyle intervention program. GDM women in the intervention group will have five consulting sessions with a dietician during the first year and two sessions during the second year. The intervention group are given detailed advice about how to achieve the five goals of the intervention. The primary aim will test whether lifestyle intervention can reduce incident Type 2 Diabetes (T2D) in women with prior GDM. The second aim will test gene-intervention interactions through fine-mapping established genes for glucose, IR, lipids, obesity and T2D in relation to metabolic traits for T2D in GDM women. The third aim will evaluate the effects of the nine-month lifestyle intervention program on cardiovascular risk factors in women with prior GDM and newly diagnosed diabetes. The forth aim will assess if a lifestyle intervention targeting both GDM mothers and their offspring can greatly improve offspring's cardimetablic risk (body weight, glucose and lipid metabolism).

Being tested
Lifestyle intervention
Keywords
Gestational diabetes mellitus, Lifestyle intervention
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionBehavioural

    The women in the intervention group will be given detailed advice about how to achieve the six evidence-based goals of the intervention,7-9 including: 1) reduction in 5-10% of initial body weight in women with body mass index (BMI) ≥24 kg/m2 through the reduction of at least 10% of total calories of their normal meals, 2) total fat intake <30% of energy consumed, 3) carbohydrate intake 55-65% of energy consumed, 4) fiber intake 20-30g per day, and 5) moderate or vigorous exercise for at least 30 min daily, seven days each week.

    --------------------------------------------------------------------------------

Study groups in NCT01554358
Study groupRoleWhat they receive
Lifestyle counselingOtherThe women in the intervention group will be given detailed advice about how to achieve the six evidence-based goals of the intervention,7-9 including: 1) reduction in 5-10% of initial body weight in women with body mass index (BMI) ≥24 kg/m2 through the reduction of at least 10% of total calories of their normal meals, 2) total fat intake <30% of energy consumed, 3) carbohydrate intake 55-65% of energy consumed, 4) fiber intake 20-30g per day, and 5) moderate or vigorous exercise for at least 30 min daily, seven days each week.
Receives: Behavioral: Lifestyle intervention
ControlNo interventionthe subjects in the control group had been educated regarding general principles of healthy lifestyle that benefits T2D and obesity prevention, and also informed about the current evidence showing that the lifestyle intervention is effective in women at high risk for T2D during the "run-in" period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incident type 2 diabetes

    Measured: during 4-year follow-up

  2. Cardiovascular risk factors

    Patients with newly diagnosed diabetes in Aim 3

    Measured: 9 month

  3. cardimetablic risk

    Children in Aim 4

    Measured: During 4-year follow-up

Secondary outcomes (1)

  1. approximately 40 SNPs

    Measured: during 4-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2012 (estimated)
  2. Study startAug 2009
  3. Primary completionJul 2011

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
2,526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01554358
Sponsor's protocol ID
TWCHC09-01
Acronym
GDM
Status last verified
Dec 2018
First submitted
13 Dec 2011
Last updated
19 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Hu G, Liu H, Li W, Wang L, Zhang S, Leng J, Li W, Liu G, Shen Y, Yang S, Gunderson E, Qi L, Yu Z, Yang X, Liu M, Shao P, Zhang F, Tian H, Tuomilehto J. Lifestyle intervention reduces type 2 diabetes incidence among young women with previous gestational diabetes: A randomized controlled trial. Chin Med J (Engl). 2026 Aug 5;139(15):2299-2308. doi: 10.1097/CM9.0000000000004043. Epub 2026 Mar 15.

    PubMed 41823088

  • Li W, Liu H, Feng L, Wang L, Zhang S, Li W, Liu G, Leng J, Shen Y, Gao R, Zhu Y, Yang X, Yu Z, Hu G. Weight change mediates the effect of lifestyle intervention on postpartum diabetes in women with prior gestational diabetes: a secondary analysis of a randomized clinical trial. BMC Med. 2026 Jan 21;24(1):97. doi: 10.1186/s12916-026-04644-y.

    PubMed 41559729

  • Joyce BT, Liu H, Wang L, Wang J, Zheng Y, Nannini D, Drong A, Shiau S, Li W, Leng J, Shen Y, Gao R, Baccarelli A, Hu G, Hou L. Novel epigenetic link between gestational diabetes mellitus and macrosomia. Epigenomics. 2021 Aug;13(15):1221-1230. doi: 10.2217/epi-2021-0096. Epub 2021 Aug 2.

    PubMed 34337972

  • Liang Z, Wang L, Liu H, Chen Y, Zhou T, Heianza Y, Leng J, Li W, Yang X, Shen Y, Gao R, Hu G, Qi L. Genetic susceptibility, lifestyle intervention and glycemic changes among women with prior gestational diabetes. Clin Nutr. 2020 Jul;39(7):2144-2150. doi: 10.1016/j.clnu.2019.08.032. Epub 2019 Sep 10.

    PubMed 31542245

  • Chen Y, Liu H, Wang L, Zhou T, Liang Z, Li W, Shang X, Leng J, Shen Y, Hu G, Qi L. Lifestyle intervention modifies the effect of the MC4R genotype on changes in insulin resistance among women with prior gestational diabetes: Tianjin Gestational Diabetes Mellitus Prevention Program. Am J Clin Nutr. 2019 Sep 1;110(3):750-758. doi: 10.1093/ajcn/nqz121.

    PubMed 31271198

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Gestational Diabetes Mellitus (GDM), run by Tianjin Women and Children's Health Center 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 5 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 19 Dec 2018. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incident type 2 diabetes (time frame: during 4-year follow-up). The study lists 3 primary outcomes in all. 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 NCT01554358, 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 19 Dec 2018.

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