Lifestyle Intervention in Pregnant Women With PCOS
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Gestational weight gain [From date of randomization until the date of delivery, assessed up to 9 months]
Secondary Outcome Measures
- Incidence of Gestational Diabetes Mellitus [From enrollment to 24-28 weeks of gestation]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
gestational age between 8 and 12 weeks of gestation, pre-pregnancy BMI≥25 (kg/m2)
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age ≥18 years, and a singleton pregnancy.
Exclusion Criteria:
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patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
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gestational weeks ≥ 13
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age <18 years
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multiple pregnancy
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uterine malformation
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or physical restriction that prevents exercise.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Beijing | China | 100026 |
Sponsors and Collaborators
- Capital Medical University
Investigators
- Principal Investigator: Guanghui Li, MD, PhD, Beijing Obstetrics and Gynecology Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Z161100000516160
- Z16110700050000