Tianjin Gestational Diabetes Prevention Program (TGDPP)

Study Overview
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Brief Summary
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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).

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

Conditions
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Gestational Diabetes Mellitus (GDM)

Intervention / Treatment
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* Behavioral: Lifestyle intervention


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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lifestyle counseling<br>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<br>* 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. --------------------------------------------------------------------------------<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| approximately 40 SNPs |  | during 4-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational diabetes mellitus, Lifestyle intervention