Lifestyle Intervention in Pregnant Women With PCOS

NCT ID: NCT04216485

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-09-30

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.

Conditions

Polycystic Ovary Syndrome; Overweight and Obesity; Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intensive Lifestyle Intervention

Intervention Type: BEHAVIORAL

Dietary intervention combined with healthy lifestyle counseling

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.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

Standard prenatal care on diet, nutrition and physical activity

Interventions

Intensive Lifestyle Intervention

Dietary intervention combined with healthy lifestyle counseling

Intervention Type: BEHAVIORAL

Standard Care

Standard prenatal care on diet, nutrition and physical activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Guanghui Li

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guanghui Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Obstetrics and Gynecology Hospital

Locations

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

Z16110700050000

Identifier Type: OTHER

Identifier Source: secondary_id

Z161100000516160

Identifier Type: -

Identifier Source: org_study_id