Lifestyle Intervention in Pregnant Women With PCOS

Capital Medical University

Status: Completed

Conditions: Gestational Diabetes; Overweight and Obesity; Polycystic Ovary Syndrome

Treatments: Behavioral: Standard Care; Behavioral: Intensive Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04216485

Z16110700050000 (Other Identifier)

Z161100000516160

Details and patient eligibility

About

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.

Full 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.

Enrollment: 296 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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296 participants in 2 patient groups

Lifestyle intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive Lifestyle Intervention

Standard Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Care