- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03600337
An Integrated Self-Management Intervention for Adolescents With Polycystic Ovary Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- University of Texas at Austin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Condition
Working to Optimize Wellness in Teens with PCOS
|
5 week, 75 minutes weekly, integrated mindfulness-based mental and physical health promotion intervention
|
No 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in psychological distress
Time Frame: Immediately post-intervention
|
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
Time Frame: Immediately post-intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Diet self-efficacy
Time Frame: Immediately post-intervention, 1-month post-intervention
|
The Diet Self-Efficacy Scale is an 11-item standardized measure assessing self-efficacy for healthy nutrition choices in three domains, (a) high caloric food temptation, (b) social and internal factors, and (c) negative emotional events.
For each item, participants select their level of confidence from 0=Not at all confident to 4= Very confident.
Item scores are summed for a possible score range from 0 (very little diet self-efficacy) to 44 (very high diet self-efficacy).
|
Immediately post-intervention, 1-month post-intervention
|
Change in Physical activity self-efficacy
Time Frame: Immediately post-intervention, 1-month post-intervention
|
The PACE Adolescent Physical Activity Survey is a 50-item standardized measure that assesses adolescents' stage of change, self-efficacy, family support, and peer support for physical activity.
Self-efficacy is assessed with 7 items rated from 1=I'm sure I can't to 5=I'm sure I can.
The mean of these 7 items will be used to assess physical activity self-efficacy immediately post-intervention and again at 1-month post-intervention with a possible score range from 1 to 7 and higher scores indicating higher self-efficacy for physical activity.
|
Immediately post-intervention, 1-month post-intervention
|
Change in self-esteem
Time Frame: Immediately post-intervention
|
The Rosenberg Self-Esteem Scale is a 10-item scale that measures an individual's self-esteem.
Participants rate each item from 3=Strongly Agree to 0=Strongly Disagree.
Scores for the 10 items are summed for a possible score from 0 to 40 with higher scores indicating higher self-esteem.
|
Immediately post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cara C Young, PhD, University of Texas at Austin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-08-0024
- 5P30NR015335 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PCOS
-
University Of PerugiaRecruiting
-
Guangdong Women and Children HospitalRecruiting
-
Khyber Medical University PeshawarCompleted
-
AdventHealth Translational Research InstituteActive, not recruiting
-
Ain Shams Maternity HospitalUnknown
-
Children's Mercy Hospital Kansas CityCompleted
-
Poznan University of Medical SciencesUniversity of California, San DiegoUnknown
-
University of SalernoTheoreo SrlCompleted
-
Genesis Center for Fertility & Human Pre-Implantation...Unknown
Clinical Trials on Working to Optimize Wellness in Tees with PCOS (WOW)
-
Memorial Sloan Kettering Cancer CenterAckerman Institute for FamilyActive, not recruitingSupport of the Family as a Caregiving SystemUnited States