Weight Loss Intervention in Women With PCOS
Weight Loss Intervention in Women With PCOS
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.
Obesity and visceral adiposity are associated with reproductive dysfunction, specifically
 infertility, problems with ovulation, and decreased rates of conception. Approximately 31% of
 reproductive aged women in the U.S. are obese. Obese women who become pregnant are at
 increased risk for miscarriage and pregnancy complications. Infertility treatment using
 assisted reproductive technologies such as fertility medications, in vitro fertilization or
 intracytoplasmic sperm injection, is time-intensive, costly, and less effective in obese
 compared with normal weight women. However, attempts at weight loss to date have been modest
 at best and the effectiveness of single component hypocaloric diets are questionable. A
 recently conducted large scale preconception weight loss study in the Netherlands randomized
 577 obese infertile women to either a lifestyle intervention prior to fertility treatment or
 prompt fertility treatment. This study found significantly higher spontaneous pregnancies in
 the lifestyle intervention group compared to those who promptly received fertility treatment.
 Additionally, when post hoc analyses were completed on predetermined subgroups, researchers
 found women with anovulation had more spontaneous pregnancies compared to ovulatory women in
 the lifestyle intervention group. A few major limitations of this study include: 1) modest
 weight loss of 4.4 kg and only 38% obtained the minimum goal of 5% weight loss; 2) the study
 included women with a variety of infertility diagnoses; and 3) limited BMI range of 29-40
 kg/m2. More prospective research is necessary to evaluate the effects of weight loss in
 anovulatory women caused by Polycystic ovarian syndrome (PCOS) as there may be larger
 benefits in this population such as restoration of ovulation and spontaneous conception.
 Additionally, there has been limited research investigating fat loss after a lifestyle
 intervention and the impact on ovulation. Fat loss may play a large role as the purported
 mechanism by which obesity influences ovulation is through insulin resistance and increased
 ovarian androgen secretion. Similar to other populations in need of lifestyle interventions,
 women seeking fertility treatment also have multiple barriers to weight management.
 Infertility treatment centers in major metropolitan cities often draw individuals from large
 geographical areas including rural dwelling individuals. 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.
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.