Tianjin Gestational Diabetes Prevention Program (TGDPP) - Full Text View

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)

Further study details as provided by Tianjin Women and Children's Health Center:

Primary Outcome Measures:

incident type 2 diabetes [ Time Frame: during 2-year follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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.

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 (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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 Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554358

Contacts


Contact: Huikun Liu, PhD	86 2258297935	huikun_liu@sina.com

Locations


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

Sponsors and Collaborators

Tianjin Women and Children's Health Center

More Information


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:	November 3, 2015
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 Glucose Metabolism Disorders	Metabolic Diseases Endocrine System Diseases Pregnancy Complications

ClinicalTrials.gov processed this record on September 27, 2016

Tianjin Gestational Diabetes Prevention Program (TGDPP) (GDM)