Weight Loss Intervention in Women With PCOS
Condition: Polycystic Ovary Syndrome; Overweight and Obesity
MeSH terms: Polycystic Ovary Syndrome; Overweight; Weight Loss
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Weight loss intervention
Intervention type(s): Behavioral
Intervention description(s): 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 group phone callsSkype will be delivered by a professional health educator (HE) to participants in their homes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment