Weight Loss Intervention in Women with Polycystic ovary syndrome (PCOS)

Our research team has developed an efficacious weight management program that has shown superior weight loss compared to conventional treatment and has successfully been delivered remotely eliminating concerns of access and transportation and may be well suited for this unique population. However, the acceptability of a remote delivered weight loss intervention, attendance at behavioral sessions, compliance with diet and physical activity (PA) recommendations and self-monitoring (diet, PA, weight), as well as the impact of the magnitude of weight loss on ovulation rates in overweight and obese anovulatory women are unknown, and will be the focus of this study.

Over a 2 mo. period, 20 overweight or obese women (BMI > 25 -45 kg/m2, age 21-38 yrs.) seeking initial treatment after 12 mos. of unsuccessful conception (~ 40 new women/mo.) will be recruited to complete a 6 mo. multicomponent weight loss intervention (WLI). Participants must be willing to withhold infertility treatment for the length of the 6 mo. intervention and have the diagnosis of ovulatory dysfunction (anovulation) caused by PCOS as the primary cause of infertility. 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.

Eligibility Criteria

Inclusion Criteria:

- Anovulatory infertility caused by Polycystic ovarian syndrome

- Age 21 to < 38.

- Body mass index (BMI) > 25 to 45 kg/m2.

- Weight stable (± 4.6 kg) in previous 3 months

- Willing to delay fertility treatment for 6 mos

Exclusion Criteria

- Unable to participate in moderate-vigorous physical activity (i.e., brisk walking)

- Currently participating in greater than 3, 30-minute bouts of planned PA/week

- Participation in a weight loss or PA program in the previous 6 mos.

- Currently on a weight loss medication (wash out period 2 mos.)

- Any other infertility diagnosis besides ovulatory dysfunction

- Binge eating disorder as assessed by the Binge Eating Scale.

Principal Investigator

Courtney Marsh, MD

Study Contact

Anna Gorczyca,agorczyca@kumc.edu, (913) 588-9077

Estimated Completion Date

Saturday, June 1, 2019

ClinicalTrials.gov #

NCT03677362
12/19/2018