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An Integrated Self-Management Intervention for Adolescents With Polycystic Ovary Syndrome

NCT ID: NCT03600337

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2020-04-01

Brief Summary

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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

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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.

Conditions

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Experimental Condition

Working to Optimize Wellness in Teens with PCOS

Group Type EXPERIMENTAL

Working to Optimize Wellness in Tees with PCOS (WOW)

Intervention Type BEHAVIORAL

5 week, 75 minutes weekly, integrated mindfulness-based mental and physical health promotion intervention

Control Condition

Participants in this arm will receive treatment as usual and will be given the intervention after 1 month assessments are completed for the intervention group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Working to Optimize Wellness in Tees with PCOS (WOW)

5 week, 75 minutes weekly, integrated mindfulness-based mental and physical health promotion intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

23 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fordham University

OTHER

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Cara Young

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cara C Young, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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5P30NR015335

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-08-0024

Identifier Type: -

Identifier Source: org_study_id