Clinical trial · Interventional
Weight Loss Intervention in Women With PCOS
NCT03677362CI-TRIAL-00046893completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The proposed single arm 6 mo. trial will assess the impact of weight loss and fat loss due to a multicomponent remotely-delivered lifestyle intervention on ovulation rates and time-to-ovulation in overweight and obese women with anovulatory infertility caused by PCOS.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Overweight and Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Weight loss intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Weight loss intervention
- description
- In the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (\~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (\~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via Skype will be delivered by a professional health educator (HE) to participants in their homes.
- interventionNames
- Behavioral: Weight loss intervention
Primary outcomes (1)
- measure
- Ovulation
- timeFrame
- 6 months
- description
- Ovulation will be assessed weekly during the 6 mo. intervention by ovulation monitoring kit and the OvuSense device.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 42 Years
Show eligibility criteria text
Inclusion Criteria: 1. Anovulatory infertility caused by Polycystic ovarian syndrome 2. Age 21 to 42. 3. Body mass index (BMI) \> 25 to 45 kg/m2. 4. Weight stable (± 4.6 kg) in previous 3 months 5. Willing to delay fertility treatment for 6 mos Exclusion Criteria: 1. Unable to participate in moderate-vigorous physical activity (i.e., brisk walking) 2. Currently participating in greater than 3, 30-minute bouts of planned PA/week 3. Participation in a weight loss or PA program in the previous 6 mos. 4. Currently on a weight loss medication (wash out period 2 mos.) 5. Any other infertility diagnosis besides ovulatory dysfunction 6. Binge eating disorder as assessed by the Binge Eating Scale.
References
Publications (1)
- DERIVEDGorczyca AM, Steger FL, Ptomey LT, Montgomery RN, Mickelsen R, Smith P, Donnelly JE, Marsh CA. The impact of a group based, remotely delivered weight loss intervention in women with polycystic ovary syndrome on ovulation, quality of life and body composition. Front Reprod Health. 2022 Jul 22;4:940945. doi: 10.3389/frph.2022.940945. eCollection 2022. PMID 36303658