NCT03062475

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
2.2 years until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

February 11, 2017

Last Update Submit

September 1, 2019

Conditions

Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (1)

  • GDM

    According to the new criteria amended in August 2014 in China, GDM was diagnosed when any one value reaches or exceeds 5.1 mmol/L at 0 hours, 10.0 mmol/L at 1 hour, or 8.5 mmol/L at 2 hours. Values of 7.0 mmol/L at 0 hours or 11.1 mmol/L at 2 hours were diagnosed as DM, regardless of the pregnancy stage

    24-28 gestational weeks

Secondary Outcomes (8)

  • birth weight

    up to 43 gestational weeks

  • gestational weeks

    up to 43 gestational weeks

  • delivery mode

    up to 43 gestational weeks

  • macrosomia

    up to 43 gestational weeks

  • LGA

    up to 43 gestational weeks

  • +3 more secondary outcomes

Study Arms (2)

lifestyle intervention group

EXPERIMENTAL

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.

Behavioral: lifestyle intervention with dietary and exercise recommendation

control group

NO INTERVENTION

Pregnant women allocated to this group receive standard prenatal care.

Interventions

lifestyle intervention with dietary and exercise recommendationBEHAVIORAL

With the dietary intervention we aimed to promote a healthy pattern of eating but not necessarily to restrict energy intake.For example we suggested exchanging carbohydrate-rich foods with a medium-to-high glycaemic index for those with a lower glycaemic index to reduce the glycaemic load, and restricting dietary intake of saturated fat. 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 during pregnancy.

lifestyle intervention group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Diet

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Huixia Yang

    Peking Unviersity First Hospital

    STUDY CHAIR

Central Study Contacts

Chen Wang

CONTACT

18518079870kisskissy22@126.com

Yumei Wei

CONTACT

18601369529weiyumei1982@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 11, 2017

First Posted

February 23, 2017

Study Start

May 1, 2019

Primary Completion

August 31, 2020

Study Completion

December 31, 2021

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

CN(1)