NCT03600337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

July 2, 2018

Last Update Submit

December 15, 2020

Conditions

PCOS

Outcome Measures

Primary Outcomes (2)

  • Change in psychological distress

    The Depression, Anxiety, and Stress Scale is a 21-item standardized scale that assess symptoms of depression, anxiety, and perceived stress. Participants rate each item from 0=Did not apply to me at all to 3=Applied to me very much or most of the time. All items are summed for a possible range from 0-63 with higher scores indicating higher levels of psychological distress.

    Immediately post-intervention

  • Change in health related quality of life

    The Child Health Questionnaire-Child Self-Report Form is an 87-item measure consisting of 12 summed subscales assessing unique physical and psychosocial domains. Items are scored from 0 to 100 with higher scores indicating better quality of life

    Immediately post-intervention

Secondary Outcomes (3)

  • Change in Diet self-efficacy

    Immediately post-intervention, 1-month post-intervention

  • Change in Physical activity self-efficacy

    Immediately post-intervention, 1-month post-intervention

  • Change in self-esteem

    Immediately post-intervention

Study Arms (2)

Experimental Condition

EXPERIMENTAL

Working to Optimize Wellness in Teens with PCOS

Behavioral: Working to Optimize Wellness in Tees with PCOS (WOW)

Control Condition

NO INTERVENTION

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

Interventions

Working to Optimize Wellness in Tees with PCOS (WOW)BEHAVIORAL

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

Experimental Condition

Eligibility Criteria

Age14 Years - 23 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Study Officials

  • Cara C Young, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 26, 2018

Study Start

June 15, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

US(1)