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

NCT03600337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-12-17

No results posted yet for this study

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.

Conditions

  • PCOS

Interventions

BEHAVIORAL

Working to Optimize Wellness in Tees with PCOS (WOW)

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

Sponsors & Collaborators

  • Fordham University

    collaborator OTHER

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Cara C Young, PhD · University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
23 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2020-04-01
Completion
2020-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600337 on ClinicalTrials.gov