Tianjin Gestational Diabetes Prevention Program (TGDPP) (GDM)
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ClinicalTrials.gov Identifier: NCT01554358 |
Recruitment Status
: Unknown
Verified November 2015 by HunKun Liu, Tianjin Women and Children's Health Center.
Recruitment status was: Recruiting
First Posted
: March 14, 2012
Last Update Posted
: November 4, 2015
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Condition or disease | Intervention/treatment | Phase |
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Gestational Diabetes Mellitus (GDM) | Behavioral: Lifestyle intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP) |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
Lifestyle counseling
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) saturated fat intake <10% of energy consumed, 4) carbohydrate intake 55-65% of energy consumed, 5) fiber intake 20-30g per day, and 6) moderate or vigorous exercise for at least 30 min daily, seven days each week.
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Behavioral: Lifestyle intervention
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) saturated fat intake <10% of energy consumed, 4) carbohydrate intake 55-65% of energy consumed, 5) fiber intake 20-30g per day, and 6) moderate or vigorous exercise for at least 30 min daily, seven days each week. |
No Intervention: Control
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.
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- incident type 2 diabetes [ Time Frame: during 2-year follow-up ]
- approximately 40 SNPs [ Time Frame: during 2-year follow-up ]

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Ages Eligible for Study: | 20 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 20-49 years
- Women diagnosed with GDM between 2005 and 2009.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554358
Contact: Huikun Liu, PhD | 86 2258297935 | huikun_liu@sina.com |
China | |
Tianjin Women's and Children's Health Center | Recruiting |
Tianjin, China, 30070 | |
Contact: Huikun Liu, PhD huikun_liu@sina.com | |
Principal Investigator: Huiguang Tian, PhD | |
Principal Investigator: Gang Hu, PhD |
Responsible Party: | HunKun Liu, Project co-investigator, Tianjin Women and Children's Health Center |
ClinicalTrials.gov Identifier: | NCT01554358 History of Changes |
Other Study ID Numbers: |
TWCHC09-01 |
First Posted: | March 14, 2012 Key Record Dates |
Last Update Posted: | November 4, 2015 |
Last Verified: | November 2015 |
Keywords provided by HunKun Liu, Tianjin Women and Children's Health Center:
Gestational diabetes mellitus Lifestyle intervention |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pregnancy Complications |