Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus

The Efficacy of Lifestyle Intervention in Preventing the the Recurrence of Gestational Diabetes Mellitus

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.

Study Overview

• Status: Unknown
• Conditions: Gestational Diabetes Mellitus (GDM)
• Intervention / Treatment: Behavioral: lifestyle intervention with dietary and exercise recommendation

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 660
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Wang; Phone Number: 18518079870; Email: kisskissy22@126.com
• Study Contact Backup: Name: Yumei Wei; Phone Number: 18601369529; Email: weiyumei1982@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Chen Wang; Phone Number: 18518079870; Email: kisskissy22@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lifestyle intervention group; 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; 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.
No Intervention: control group; Pregnant women allocated to this group receive standard prenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
birth weight	birth weight measured after baby was delivered and accurate to 0.1 kg	up to 43 gestational weeks
gestational weeks	record the gestational weeks for delivery	up to 43 gestational weeks
delivery mode	this includes vaginal delivery, operative vaginal delivery or cesarean delivery	up to 43 gestational weeks
macrosomia	birth weight above 4000.0 g	up to 43 gestational weeks
LGA	birth weight above the 90th percentile for gestational age	up to 43 gestational weeks
SGA	birth weight below the 10th percentile for gestational age	up to 43 gestational weeks
gestational hypertention	defined as blood pressure elevation [systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg] after 20 weeks gestation in the absence of proteinuria	up to 43 gestational weeks
pre-eclampsia	defined as new-onset hypertension [systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg] and new-onset proteinuria [300 mg of protein in 24 hours or a urine protein/creatinine ratio of 0.3 mg/dL] after 20 weeks gestation or, in the absence of proteinuria, new-onset hypertension with new-onset thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual disturbances	up to 43 gestational weeks

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Study Chair: Huixia Yang, Peking Unviersity First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 11, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 1, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pregnancy Complications; Diabetes Mellitus; Recurrence; Diabetes, Gestational
• Other Study ID Numbers: 20170226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No