Lifestyle Intervention in Pregnant Women With PCOS

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Gestational Diabetes; Overweight and Obesity
• Interventions: Behavioral: Intensive Lifestyle Intervention; Behavioral: Standard Care

• Registration Number: NCT04216485
• Lead Sponsor: Capital Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-21
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 296

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Intensive Lifestyle Intervention	Intervention group: Intensive lifestyle intervention will be initiated from the first trimester (8-12wks) to delivery, with follow up every 2-4 weeks. Participants in the intervention group will be provided with an individualized dietary protocol with not less than 1500 calories per day in the first trimester and not less than 1800 calories per day after 13 weeks of gestation. Guidance on regular exercise is reinforced at the first and each follow up visit.
Standard Care	Standard Care	Standard care group: Participants will receive a 1.5-hour group session in which standard prenatal intervention on diet, nutrition and physical activity and recommendation for gestational weight gain are reviewed by a registered dietitian. Thereafter, participants will receive their regularly scheduled follow up visits without additional lifestyle guidance.

Primary Outcome Measures

Name	Time	Method
Gestational weight gain	From date of randomization until the date of delivery, assessed up to 9 months

Secondary Outcome Measures

Name	Time	Method
Incidence of Gestational Diabetes Mellitus	From enrollment to 24-28 weeks of gestation

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital,Capital Medical University; 🇨🇳 Beijing, China