Lifestyle Intervention in Pregnant Women With PCOS

Overweight and Obesity Clinical Trial

Official title:

Intensive Lifestyle Intervention on Gestational Weight Gain and Development of Gestational Diabetes Mellitus in Overweight/Obese Pregnant Women With a History of Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216485
• Other study ID #: Z161100000516160
• Secondary ID: Z16110700050000
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2021
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polycystic ovarian syndrome (PCOS) is the most common reproductive disorder in women of childbearing age and is also associated with metabolic abnormalities including obesity, type 2 diabetes, dyslipidemia, etc. Importantly, a number of adverse outcome are seen in pregnancies complicated by PCOS, including gestational diabetes mellitus (GDM), preeclampsia and miscarriage. However, optimal management of PCOS complicated pregnancy is not known. This study seeks to explore whether healthy lifestyle intervention in overweight/obese pregnant women with PCOS could reduce gestational weight gain (GWG) and incidence of GDM.

Description:

A randomized controlled trial in PCOS pregnant women will be initiated at 8-12 weeks of gestation util delivery. Participants will be randomly assigned to the control group (standard care) or the intervention group (intensive lifestyle intervention). The intervention will focus on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcome will be GWG and secondary outcome will be the incidence of GDM. Our hypothesis is that intensive lifestyle intervention in overweight/obese pregnant women with PCOS will decrease GWG and reduce the incidence of GDM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• gestational age between 8 and 12 weeks of gestation, pre-pregnancy BMI=25 (kg/m2)
• age =18 years, and a singleton pregnancy.

Exclusion Criteria:

• patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
• gestational weeks = 13
• age <18 years
• multiple pregnancy
• uterine malformation
• or physical restriction that prevents exercise.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Overweight
• Overweight and Obesity
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Behavioral:
• Intensive Lifestyle Intervention
Dietary intervention combined with healthy lifestyle counseling
• Standard Care
Standard prenatal care on diet, nutrition and physical activity

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital,Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational weight gain		From date of randomization until the date of delivery, assessed up to 9 months
Secondary	Incidence of Gestational Diabetes Mellitus		From enrollment to 24-28 weeks of gestation