Clinical trial · Interventional
Lifestyle Intervention in Pregnant Women With PCOS
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gestational Diabetes | — | UNRESOLVED | — |
| Overweight and Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensive Lifestyle Intervention | Behavioral | — | UNRESOLVED |
| Standard Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lifestyle intervention
- 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.
- interventionNames
- Behavioral: Intensive Lifestyle Intervention
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- 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.
- interventionNames
- Behavioral: Standard Care
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available