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Lifestyle Intervention in Pregnant Women With PCOS

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ClinicalTrials.gov Identifier: NCT04216485
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Guanghui Li, 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Overweight and Obesity Gestational Diabetes Behavioral: Intensive Lifestyle Intervention Behavioral: Standard Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Study Start Date : October 2016
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Intensive Lifestyle Intervention
Dietary intervention combined with healthy lifestyle counseling

Active Comparator: 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.
Behavioral: Standard Care
Standard prenatal care on diet, nutrition and physical activity




Primary Outcome Measures :
  1. Gestational weight gain [ Time Frame: From date of randomization until the date of delivery, assessed up to 9 months ]

Secondary Outcome Measures :
  1. Incidence of Gestational Diabetes Mellitus [ Time Frame: From enrollment to 24-28 weeks of gestation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216485


Contacts
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Contact: Guanghui Li, MD, PhD 008613124728821 liguanghui2007@163.com
Contact: Wenyu Huang, MD, PhD 847-312-2140 huangwenyu@md.northwestern.edu

Locations
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China
Beijing Obstetrics and Gynecology Hospital,Capital Medical University Recruiting
Beijing, China, 100026
Contact: Guanghui Li, MD,PHD    86-10-52273110    liguanghui2007@163.com   
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Guanghui Li, MD, PhD Beijing Obstetrics and Gynecology Hospital
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Responsible Party: Guanghui Li, Associate Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT04216485    
Other Study ID Numbers: Z161100000516160
Z16110700050000 ( Other Identifier: Beijing Municipal Science and Technology Commission )
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Diabetes, Gestational
Syndrome
Overweight
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases