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Lifestyle Intervention in Pregnant Women With PCOS

Primary Purpose

Polycystic Ovary Syndrome, Overweight and Obesity, Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intensive Lifestyle Intervention
Standard Care
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle intervention

Standard Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

Gestational weight gain

Secondary Outcome Measures

Incidence of Gestational Diabetes Mellitus

Full Information

First Posted
November 21, 2016
Last Updated
July 26, 2021
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04216485
Brief Title
Lifestyle Intervention in Pregnant Women With PCOS
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Overweight and Obesity, Gestational Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm 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.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Lifestyle Intervention
Intervention Description
Dietary intervention combined with healthy lifestyle counseling
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Standard prenatal care on diet, nutrition and physical activity
Primary Outcome Measure Information:
Title
Gestational weight gain
Time Frame
From date of randomization until the date of delivery, assessed up to 9 months
Secondary Outcome Measure Information:
Title
Incidence of Gestational Diabetes Mellitus
Time Frame
From enrollment to 24-28 weeks of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guanghui Li, MD, PhD
Organizational Affiliation
Beijing Obstetrics and Gynecology Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
City
Beijing
ZIP/Postal Code
100026
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lifestyle Intervention in Pregnant Women With PCOS

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