Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus

P

Peking University

Status

Unknown

Conditions

Gestational Diabetes Mellitus (GDM)

Treatments

Behavioral: lifestyle intervention with dietary and exercise recommendation

Study type

Interventional

Funder types

Other

Identifiers

NCT03062475
20170226

Details and patient eligibility

About

Gestational diabetes mellitus(GDM) is a commom complication during pregnancy and associated with various adverse pregnancy outcomes for both the mother and her offspring. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM.

Full description

Gestational diabetes mellitus(GDM) is a commom complication during pregnancy. and the incidence has reached as high as 19.2% in China. GDM is associated with various adverse pregnancy outcomes for both the mother and her offspring, and not only during the perinatal phase, but also in the long term.Thus finding effective way to reduce the risk of GDM is of great importance,especial for women with high GDM risk factors. GDM history is one of the risk factors. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM

Enrollment

660 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Singleton;
  • non-smoking ;
  • before 12+6 weeks gestation.

Exclusion criteria

  • less than 18 years old;
  • unwilling to provide informed consent;
  • cervical insufficiency;
  • women on any medication for pre-existing hypertension, diabetes, cardiac disease, renal disease, systemic lupus erythematosus, thyroid disease or psychosis;
  • women who were currently being treated with metformin or corticosteroids.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

660 participants in 2 patient groups

lifestyle intervention group
Experimental group
Description:
Pregnant women allocated to this group receive lifestyle intervention. With the dietary intervention we aimed to promote a healthy pattern of eating but not necessarily to restrict energy intake. With respect to advice on physical activity, we focused on incremental increases in walking from a pedometer assessed or encourage them to do moderate cycling.
Treatment:
Behavioral: lifestyle intervention with dietary and exercise recommendation
control group
No Intervention group
Description:
Pregnant women allocated to this group receive standard prenatal care.

Trial contacts and locations

0

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Central trial contact

Yumei Wei; Chen Wang

Data sourced from clinicaltrials.gov

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