NCT01554358

Brief 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. 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,526

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.9 years

First QC Date

December 13, 2011

Last Update Submit

December 14, 2018

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational diabetes mellitusLifestyle intervention

Outcome Measures

Primary Outcomes (3)

  • incident type 2 diabetes

    during 4-year follow-up

  • Cardiovascular risk factors

    Patients with newly diagnosed diabetes in Aim 3

    9 month

  • cardimetablic risk

    Children in Aim 4

    During 4-year follow-up

Secondary Outcomes (1)

  • approximately 40 SNPs

    during 4-year follow-up

Study Arms (2)

Lifestyle counseling

OTHER

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.

Behavioral: Lifestyle intervention

Control

NO INTERVENTION

the 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.

Interventions

Lifestyle interventionBEHAVIORAL

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. \--------------------------------------------------------------------------------

Lifestyle counseling

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-49 years
  • Women diagnosed with GDM between 2005 and 2009.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Women's and Children's Health Center

Tianjin, 30070, China

Location

Related Publications (4)

  • 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. doi: 10.1186/s12916-026-04644-y. Online ahead of print.

    PMID: 41559729DERIVED

  • 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.

    PMID: 34337972DERIVED

  • 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.

    PMID: 31542245DERIVED

  • 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.

    PMID: 31271198DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project co-investigator

Study Record Dates

First Submitted

December 13, 2011

First Posted

March 14, 2012

Study Start

August 1, 2009

Primary Completion

July 1, 2011

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations

CN(1)