An Integrated Self-Management Intervention for Adolescents With Polycystic Ovary Syndrome
Condition: PCOS
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      Polycystic ovary syndrome (PCOS) is the most common female endocrine disorder, affecting
      7%-18% of reproductive-age women. Women with PCOS are at increased risk for a number of
      adverse physical and mental health outcomes. Often diagnosed during the challenging
      developmental period of adolescence (ages 14-18), current clinical practice guidelines fail
      to consider the life-long nature of effective PCOS self-management through sustained healthy
      lifestyle habits and may, in fact, contribute to maladaptive patterns of unsustainable
      strategies for weight loss in adolescents. The investigators are testing an integrated
      mindfulness-based healthy lifestyle intervention for adolescents with PCOS (Working to
      Optimize Wellness in Teens with PCOS [WOW]). The purpose of this study is to obtain data
      supporting preliminary efficacy of WOW on biological and mental health outcomes with
      adolescents diagnosed with PCOS.
    

Detailed description: 
      Innovative approaches to addressing the unique physical and mental health needs of
      adolescents with PCOS are needed. In response to this need, the investigators have developed
      an integrated mindfulness-based healthy lifestyle intervention for adolescents with PCOS
      (Working to Optimize Wellness in Teens with PCOS [WOW] through an iterative process of serial
      focus groups with adolescents and parents of adolescents with PCOS guided by the Individual
      and Family Self-Management Theory (IFSMT). In this pilot randomized control trial (RCT), 40
      adolescents aged 14-18 years will be recruited to participate in the 5-week Working to
      Optimize Wellness in Teens with PCOS (WOW) intervention (N=20) or a waitlist-control
      condition (n=20). All participants will receive treatment as usual. Participants will meet
      weekly for 75-90 minutes for five weeks. Data collection will occur at 3 time points:
      Baseline data (T1) will be collected from all participants immediately following the informed
      consent process, Time 2 (T2) data will be collected immediately post-intervention, and Time 3
      (T3) data will be collected one-month post-intervention. The waitlist- control condition will
      receive the intervention immediately following the one-month post-intervention data
      collection period. Following completion of the self-report measures at T3, individual exit
      interviews will be conducted with a subset of participants (N=10) from the WOW condition.

      The primary aims of this research study are:

      1. To conduct a pilot RCT with 40 adolescents (ages 14-18) diagnosed with PCOS comparing WOW
      (n=20) to a wait-list control condition (n=20), and conduct individual exit-interviews to
      further refine WOW. The investigators expect to determine:

      a. Preliminary effects of WOW vs. wait-list control on blood pressure, fasting insulin,
      hemoglobin A1C, nutrition self-efficacy, physical activity, medication adherence,
      psychological well-being (i.e., depressive/anxiety symptoms, perceived stress, self-esteem)
      and health related quality of life.
    

Intervention name(s): Working to Optimize Wellness in Tees with PCOS (WOW)
Intervention type(s): Behavioral
Intervention description(s): 5 week, 75 minutes weekly, integrated mindfulness-based mental and physical health promotion intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention