An Integrated Self-Management Intervention for Adolescents With Polycystic Ovary Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 14 - 18 |
| Updated: | 7/27/2018 |
| Start Date: | June 15, 2018 |
| End Date: | March 31, 2019 |
| Contact: | Cara C Young, PhD |
| Email: | carayoung@utexas.edu |
| Phone: | 512-471-7952 |
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.
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.
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.
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.
Inclusion Criteria:
- adolescent age 14-18 years,
- diagnosis of PCOS for at least 6 months,
- 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
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