PCOSNCT03600337
An Integrated Self-Management Intervention for Adolescents With Polycystic Ovary Syndrome
A study testing Working to Optimize Wellness in Tees with PCOS (WOW) in people with PCOS, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 23 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Working to Optimize Wellness in Tees with PCOS (WOW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- adolescent age 14-23 years,
- diagnosis of PCOS, OR obesity AND secondary amenorrhea, OR excessive and frequent menstruation and
- ability to provide informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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:
- 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
- PCOS
- Being tested
- Working to Optimize Wellness in Tees with PCOS (WOW)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working to Optimize Wellness in Tees with PCOS (WOW)Behavioural
5 week, 75 minutes weekly, integrated mindfulness-based mental and physical health promotion intervention
| Study group | Role | What they receive |
|---|---|---|
| Experimental Condition | Experimental | Working to Optimize Wellness in Teens with PCOS Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Immediately post-intervention
Secondary outcomes (3)
Change in Diet self-efficacy
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).
Measured: Immediately post-intervention, 1-month post-intervention
Change in Physical activity self-efficacy
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.
Measured: Immediately post-intervention, 1-month post-intervention
Change in self-esteem
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.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start15 Jun 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Fordham University, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Cara Young, University of Texas at Austin
- Investigators
- Cara C Young, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600337
- Sponsor's protocol ID
- 2017-08-0024
- Other IDs
- 5P30NR015335
- Status last verified
- Dec 2020
- First submitted
- 2 Jul 2018
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Self-Management Intervention for Adolescents With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03600337
- Acronym / sponsor ID
- 2017-08-0024
- Conditions
- PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Fordham University, National Institute of Nursing Research (NINR)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition | Experimental | Behavioral: Working to Optimize Wellness in Tees with PCOS (WOW)Working to Optimize Wellness in Teens with PCOS |
| 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 |
Who may qualify
- Ages
- 14 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- adolescent age 14-23 years,
- diagnosis of PCOS, OR obesity AND secondary amenorrhea, OR excessive and frequent menstruation and
- ability to provide informed consent.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Working to Optimize Wellness in Tees with PCOS (WOW)5 week, 75 minutes weekly, integrated mindfulness-based mental and physical health promotion intervention | Behavioural | Experimental Condition |
Primary outcome
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.
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
3 secondary outcomes
Change in Diet self-efficacy
Time frame: Immediately post-intervention, 1-month post-intervention
Change in Physical activity self-efficacy
Time frame: Immediately post-intervention, 1-month post-intervention
Change in self-esteem
Time frame: Immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
Related trials for PCOS
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara C Young, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working to Optimize Wellness in Tees with PCOS (WOW) in people with PCOS, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychological distress (time frame: Immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.