Tianjin Gestational Diabetes Prevention Program (TGDPP)

Not Applicable

• Conditions: Gestational Diabetes Mellitus (GDM)
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT01554358
• Lead Sponsor: Tianjin Women and Children's Health Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-07
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-14
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2526

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	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) 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.

Primary Outcome Measures

Name	Time	Method
incident type 2 diabetes	during 4-year follow-up
cardimetablic risk	During 4-year follow-up	Children in Aim 4
Cardiovascular risk factors	9 month	Patients with newly diagnosed diabetes in Aim 3

Secondary Outcome Measures

Name	Time	Method
approximately 40 SNPs	during 4-year follow-up

Trial Locations

Locations (1)

Tianjin Women's and Children's Health Center; 🇨🇳 Tianjin, China