Tianjin Gestational Diabetes Prevention Program (TGDPP) (GDM)
Recruitment status was Recruiting
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Purpose
A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009 have and continues to be randomly assigned to either the intervention group or the control group. 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 six 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.
| Condition | Intervention |
|---|---|
|
Gestational Diabetes Mellitus (GDM) |
Behavioral: Lifestyle intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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) |
- incident type 2 diabetes [ Time Frame: during 2-year follow-up ] [ Designated as safety issue: Yes ]
- approximately 40 SNPs [ Time Frame: during 2-year follow-up ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1180 |
| Study Start Date: | August 2009 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 20 Years to 49 Years |
| Genders 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 | |
More Information
No publications provided
| 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 |
| Study First Received: | December 13, 2011 |
| Last Updated: | March 12, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Tianjin Women and Children's Health Center:
|
Gestational diabetes mellitus Lifestyle intervention |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases |
Glucose Metabolism Disorders Metabolic Diseases Pregnancy Complications |
ClinicalTrials.gov processed this record on February 27, 2015