Lifestyle Intervention in Pregnant Women With PCOS

NCT04216485 | Completed DMC

• 2 other identifiers: Z161100000516160Z16110700050000
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Overweight and Obesity; Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain

  From date of randomization until the date of delivery, assessed up to 9 months

Secondary Outcomes (1)

• Incidence of Gestational Diabetes Mellitus

  From enrollment to 24-28 weeks of gestation

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Intensive Lifestyle Intervention

Standard Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Care

Interventions

Intensive Lifestyle Intervention BEHAVIORAL

Dietary intervention combined with healthy lifestyle counseling

Lifestyle intervention

Standard Care BEHAVIORAL

Standard prenatal care on diet, nutrition and physical activity

Standard Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, 100026, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Overweight; Obesity; Diabetes, Gestational

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Guanghui Li, MD, PhD

  Beijing Obstetrics and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: January 2, 2020
• Study Start: October 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)