Clinical trial NCT03600337: An Integrated Self-Management Intervention for Adolescents With Polycystic Ovary Syndrome
Official title: An Integrated Self-Management Intervention for Adolescents With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Fordham University
name: National Institute of Nursing Research (NINR)
First posted: 2018-07-26
Enrollment: 56
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* adolescent age 14-23 years,
* diagnosis of PCOS, OR obesity AND secondary amenorrhea, OR excessive and frequent menstruation and
* ability to provide informed consent.

Exclusion Criteria:

* inability to commit to attending all intervention sessions
* unable to provide written informed consent/assent
* loss of a loved one within the last year, or
* history of post-traumatic stress disorder

Primary outcomes:
measure: Change in psychological distress
timeFrame: Immediately post-intervention
measure: Change in health related quality of life
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Change in Diet self-efficacy
timeFrame: Immediately post-intervention, 1-month post-intervention
measure: Change in Physical activity self-efficacy
timeFrame: Immediately post-intervention, 1-month post-intervention
measure: Change in self-esteem
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Cara C Young, PhD
role: PRINCIPAL_INVESTIGATOR
References: