Lifestyle Intervention in Pregnant Women With PCOS

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Polycystic Ovary Syndrome, Overweight and Obesity, Gestational Diabetes

Intervention / Treatment
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* Behavioral: Intensive Lifestyle Intervention
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention<br>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<br>* Dietary intervention combined with healthy lifestyle counseling<br>|
| Active Comparator: Standard Care<br>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<br>* Standard prenatal care on diet, nutrition and physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain |  | From date of randomization until the date of delivery, assessed up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Gestational Diabetes Mellitus |  | From enrollment to 24-28 weeks of gestation |