Assessing whether meditation improves quality of life for adolescent girls with polycystic ovary syndrome : Protocol for a randomized controlled trial

Journal article

Hewawasam, Erandi, Brennan, Leah, Giles, Lynne, Hull, Mary Louise, Short, Asha, Norman, Robert and Peña, Alexia S.. (2020). Assessing whether meditation improves quality of life for adolescent girls with polycystic ovary syndrome : Protocol for a randomized controlled trial. JMIR Research Protocols. 9(1), p. e14542. https://doi.org/10.2196/14542
AuthorsHewawasam, Erandi, Brennan, Leah, Giles, Lynne, Hull, Mary Louise, Short, Asha, Norman, Robert and Peña, Alexia S.
Abstract

Background:
Polycystic Ovary Syndrome (PCOS) is a common endocrine condition characterized by irregular periods and hyperandrogenism. Adolescents with PCOS have impaired quality of life (QOL) and increased psychological distress. Transcendental Meditation (TM) is a well-established self-management strategy that has been used to improve stress and well-being. A meta-analysis of TM trials has shown beneficial effects on stress and blood pressure in adults. Recent data are suggesting that another self-management strategy called a mindfulness stress management program has a role in improving QOL in women with PCOS, but there are no studies in adolescents.

Objective:
This study aims to evaluate the effect of TM on QOL and psychological distress in adolescent girls with PCOS.

Methods:
This study is a randomized controlled trial that will be conducted over eight weeks at the Women’s and Children’s Hospital in Adelaide, South Australia, to determine the effect of TM on QOL and psychological distress in adolescent girls (aged 12-20 years) with PCOS. A total of 40 girls will be randomized into either the TM (n=20) or control group (n=20). The TM group will be asked to practice TM in a comfortable sitting position with the eyes closed, for 15 minutes twice daily over eight weeks. The control group will be asked to sit quietly for 15 minutes twice daily for eight weeks. The primary outcomes are any effects on improving QOL and psychological distress, and the secondary outcomes are any effects on lowering blood pressure and salivary cortisol levels.

Results:
The recruitment of study participants began in May 2019 and is expected to be completed by June 2020. It is expected that the adolescent girls with PCOS practicing TM over eight weeks will have a significant improvement in QOL and psychological distress compared to adolescents in the control group. Also, it is expected that adolescent girls in the TM group will have lower salivary cortisol levels and lower blood pressure.

Conclusions:
This study will be the first to evaluate the effect of TM on QOL in adolescent girls with PCOS. The study will provide valuable information on a potential self-management strategy to improve QOL and well-being in adolescent girls with PCOS.

Trial Registration:
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN1261900019010; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376...

International Registered Report Identifier (IRRID):
PRR1-10.2196/14542

Keywordsmeditation; quality of life; polycystic ovary syndrome; adolescent
Year2020
JournalJMIR Research Protocols
Journal citation9 (1), p. e14542
PublisherJ M I R Publications
ISSN1929-0748
Digital Object Identifier (DOI)https://doi.org/10.2196/14542
Scopus EID2-s2.0-85083442122
Open accessPublished as ‘gold’ (paid) open access
Research or scholarlyResearch
Page range1-10
Publisher's version
License
File Access Level
Open
Output statusPublished
Publication dates
Online2020
Publication process dates
Deposited28 Jun 2021
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A cluster randomised controlled trial of a telephone-based intervention targeting the home food environment of preschoolers (The Healthy Habits Trial) : The effect on parent fruit and vegetable consumption
Wyse, Rebecca, Brennan, Leah, Wolfenden, Luke and Campbell, Karen. (2014). A cluster randomised controlled trial of a telephone-based intervention targeting the home food environment of preschoolers (The Healthy Habits Trial) : The effect on parent fruit and vegetable consumption. International Journal of Behavioral Nutrition and Physical Activity. 11(144), pp. 1 - 9. https://doi.org/10.1186/s12966-014-0144-6
Biopsychosocial outcomes of laparoscopic adjustable gastric banding in adolescents: A systematic review of the literature
Willcox, Kim and Brennan, Leah. (2014). Biopsychosocial outcomes of laparoscopic adjustable gastric banding in adolescents: A systematic review of the literature. Obesity Surgery. 24(9), pp. 1510 - 1519. https://doi.org/10.1007/s11695-014-1273-3
Physiological and behavioural outcomes of a randomised controlled trial of a cognitive behavioural lifestyle intervention for overweight and obese adolescents
Brennan, Leah, Walkley, Jeff, Wilks, Ray, Fraser, Steve and Greenway, Kate. (2013). Physiological and behavioural outcomes of a randomised controlled trial of a cognitive behavioural lifestyle intervention for overweight and obese adolescents. Obesity Research and Clinical Practice. https://doi.org/10.1016/j.orcp.2012.02.010
Psychosocial predictors of 4 year BMI change in overweight and obese children in primary care
Incledon, Emily, Gerner, Bibi, Hay, Margaret, Brennan, Leah and Wake, Melissa. (2013). Psychosocial predictors of 4 year BMI change in overweight and obese children in primary care. Obesity: a resourch journal. https://doi.org/10.1002/oby.20050
Long-term outcomes after bariatric surgery : fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature
O'Brien, Paul Edmond, MacDonald, Leah, Anderson, Margaret, Brennan, Leah and Brown, Wendy. (2013). Long-term outcomes after bariatric surgery : fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Annals Of Surgery. https://doi.org/10.1056/JC200502110000004
Evaluation of the Recovery Is Possible for Everyone transdiagnostic treatment and support program for adults with eating disorders
Harry, Sarah, Sutherland, Fiona, McCarthy, Bree, Richards, Karen and Brennan, Leah. (2013). Evaluation of the Recovery Is Possible for Everyone transdiagnostic treatment and support program for adults with eating disorders. Journal of Eating Disorders. 1(1). https://doi.org/10.1186/2050-2974-1-S1-O2
Pre-operative weight loss does not predict weight loss following laparoscopic adjustable gastric banding
Brown, Wendy, Moszkowicz, Julia, Brennan, Leah, Burton, Paul, Anderson, Margaret and O'Brien, Paul Edmond. (2013). Pre-operative weight loss does not predict weight loss following laparoscopic adjustable gastric banding. Obesity Surgery. https://doi.org/10.1007/s11695-013-0974-3
Psychosocial outcomes of a non-dieting based positive body image community program for overweight adults : A pilot study
Bloom, Lisa, Shelton, Beth, Bengough, Melissa and Brennan, Leah. (2013). Psychosocial outcomes of a non-dieting based positive body image community program for overweight adults : A pilot study. Journal of Eating Disorders. https://doi.org/10.1186/2050-2974-1-44
Intensive medical weight loss or laparoscopic adjustable gastric banding in the treatment of mild to moderate obesity : long-term follow-up of a prospective randomised trial
O'Brien, Paul Edmond, Brennan, Leah, Laurie, Cheryl and Brown, Wendy. (2013). Intensive medical weight loss or laparoscopic adjustable gastric banding in the treatment of mild to moderate obesity : long-term follow-up of a prospective randomised trial. Obesity Surgery. https://doi.org/10.1007/s11695-013-0990-3
Pre-operative weight loss does not predict weight loss following laparoscopic adjustable gastric banding
Brown, Wendy, Moszkowicz, Julia, Brennan, Leah, Burton, Paul, Anderson, Margaret and O'Brien, Paul Edmond. (2013). Pre-operative weight loss does not predict weight loss following laparoscopic adjustable gastric banding. Obesity Surgery. https://doi.org/10.1007/s11695-013-0974-3
A systematic review of variables associated with the relationship between obesity and depression
Preiss, K, Brennan, Leah and Clarke, David. (2013). A systematic review of variables associated with the relationship between obesity and depression. Obesity Reviews. https://doi.org/10.1111/obr.12052
Defining disordered eating trajectories across adolescence and assessing their impact on psychosocial outcomes using growth mixture modelling
Mitchell, Sarah A., Brennan, Leah, Krug, Isabel and Allen, Nicholas B.. (2013). Defining disordered eating trajectories across adolescence and assessing their impact on psychosocial outcomes using growth mixture modelling. https://doi.org/10.1186/2050-2974-1-S1-O65
Maternal controlling feeding behaviours and child eating in preschool-aged children
Moroshko, Irina and Brennan, Leah. (2013). Maternal controlling feeding behaviours and child eating in preschool-aged children. Nutrition and Dietetics. https://doi.org/10.1111/j.1747-0080.2012.01631.x
Intensive medical weight loss or laparoscopic adjustable gastric banding in the treatment of mild to moderate obesity : long-term follow-up of a prospective randomised trial
O'Brien, Paul Edmond, Brennan, Leah, Laurie, Cheryl and Brown, Wendy. (2013). Intensive medical weight loss or laparoscopic adjustable gastric banding in the treatment of mild to moderate obesity : long-term follow-up of a prospective randomised trial. Obesity Surgery. https://doi.org/10.1007/s11695-013-0990-3
Physiological and behavioural outcomes of a randomised controlled trial of a cognitive behavioural lifestyle intervention for overweight and obese adolescents
Brennan, Leah, Walkley, Jeff, Wilks, Ray, Fraser, Steve and Greenway, Kate. (2013). Physiological and behavioural outcomes of a randomised controlled trial of a cognitive behavioural lifestyle intervention for overweight and obese adolescents. Obesity Research and Clinical Practice. https://doi.org/10.1016/j.orcp.2012.02.010
A cluster randomised controlled trial of a telephone-based parent intervention to increase preschoolers' fruit and vegetable consumption
Wyse, Rebecca, Wolfenden, Luke, Campbell, Elizabeth, Campbell, Karen, Wiggers, John, Brennan, Leah, Fletcher, Amanda, Bowman, Jenny and Heard, Todd. (2012). A cluster randomised controlled trial of a telephone-based parent intervention to increase preschoolers' fruit and vegetable consumption. American Journal of Clinical Nutrition: A journal reporting the practical application of our world-wide knowledge of nutrition. 96(1), pp. 102 - 110. https://doi.org/10.3945/ajcn.111.030585
Predictors of attrition in bariatric aftercare : a systematic review of the literature
Moroshko, Irina, Brennan, Leah and O'Brien, Paul. (2012). Predictors of attrition in bariatric aftercare : a systematic review of the literature. Obesity Surgery. 22(10), pp. 1640 - 1647. https://doi.org/10.1007/s11695-012-0691-3
Promoting protective factors for young adolescents : ABCD Parenting Young Adolescents Program randomised controlled trial
Burke, Kylie, Brennan, Leah and Cann, Warren. (2012). Promoting protective factors for young adolescents : ABCD Parenting Young Adolescents Program randomised controlled trial. Journal of Adolescence. 35(5), pp. 1315 - 1328. https://doi.org/10.1016/j.adolescence.2012.05.002
Parenting styles, communication and child/adolescent diets andweight status : let's talk about it
Parletta, Natalie, Peters, Jacqueline, Owen, Amber, Tsiros, Margarita and Brennan, Leah. (2012). Parenting styles, communication and child/adolescent diets andweight status : let's talk about it. Early Child Development and Care. 182(8), pp. 1089 - 1103. https://doi.org/10.1080/03004430.2012.678597
Does exercise improve weight loss after bariatric surgery? : A systematic review
Egberts, Kristine, Brown, Wendy, Brennan, Leah and O'Brien, Paul. (2012). Does exercise improve weight loss after bariatric surgery? : A systematic review. Obesity Surgery. 22(2), pp. 335 - 341. https://doi.org/10.1007/s11695-011-0544-5
Treatment acceptability and psychosocial outcomes of a randomised controlled trial of a cognitive behavioural lifestyle intervention for overweight and obese adolescents
Brennan, Leah, Wilks, Ray, Walkley, Jeff, Fraser, Steve and Greenway, Kate. (2012). Treatment acceptability and psychosocial outcomes of a randomised controlled trial of a cognitive behavioural lifestyle intervention for overweight and obese adolescents. Behaviour Change. 29(1), pp. 36 - 62. https://doi.org/10.1017/bec.2012.5
Parent- and adolescent-reported barriers to participation in an adolescent overweight and obesity intervention
Brennan, Leah, Walkley, Jeff and Wilks, Ray. (2012). Parent- and adolescent-reported barriers to participation in an adolescent overweight and obesity intervention. Obesity: a resourch journal. 20(6), pp. 1319 - 1324. https://doi.org/10.1038/oby.2011.358
Validity of the beck depression inventory as a screening tool for a clinical mood disorder in bariatric surgery candidates
Hayden, Melissa J., Brown, Wendy A., Brennan, Leah and O'Brien, Paul Edmond. (2012). Validity of the beck depression inventory as a screening tool for a clinical mood disorder in bariatric surgery candidates. Obesity Surgery. 22(11), pp. 1666 - 1675. https://doi.org/10.1007/s11695-012-0682-4
In people with poorly controlled type 2 diabetes, cognitive behaviour therapy combined with motivational enhancement therapy reduces HbA1c after 12 months
Brennan, Leah. (2011). In people with poorly controlled type 2 diabetes, cognitive behaviour therapy combined with motivational enhancement therapy reduces HbA1c after 12 months. Worldviews on Evidence-Based Nursing. 14(3), pp. 72 - 73. https://doi.org/10.1136/ebn1164
In people with poorly controlled type 2 diabetes, cognitive behaviour therapy combined with motivational enhancement therapy reduces HbA1c after 12 months
Brennan, Leah. (2011). In people with poorly controlled type 2 diabetes, cognitive behaviour therapy combined with motivational enhancement therapy reduces HbA1c after 12 months. Worldviews on Evidence-Based Nursing. 14(3), pp. 72 - 73. https://doi.org/10.1136/ebn1164
Predictors of dropout in weight loss interventions :a systematic review of the literature
Moroshko, Irina, Brennan, Leah and O'Brien, Paul Edmond. (2011). Predictors of dropout in weight loss interventions :a systematic review of the literature. Obesity Reviews. 12(11), pp. 912 - 934. https://doi.org/10.1111/j.1467-789X.2011.00915.x
Primary Goals for Weight Loss Questionnaire (PGWLQ) :Development and Psychometric Evaluation in Overweight and Obese Adults
Murphy, Kylie, Brennan, Leah, Walkley, Jeff, Reece, John and Little, Emma. (2011). Primary Goals for Weight Loss Questionnaire (PGWLQ) :Development and Psychometric Evaluation in Overweight and Obese Adults. Behaviour Change. 28(1), pp. 29 - 43. https://doi.org/10.1375/bech.28.1.29
Self-Monitoring in the Treatment of Overweight Adolescents
Sandilands, Mary, Brennan, Leah, Walkley, Jeff, Fraser, Steve and Greenway, Kate. (2011). Self-Monitoring in the Treatment of Overweight Adolescents. Behaviour Change. 28(2), pp. 97 - 109. https://doi.org/10.1375/bech.28.2.97
Predicting treatment initiation in a family-based adolescent overweight and obesity intervention
Dhingra, Akshay, Brennan, Leah and Walkley, Jeff. (2011). Predicting treatment initiation in a family-based adolescent overweight and obesity intervention. Obesity: a resourch journal. 19(6), pp. 1307 - 1310. https://doi.org/10.1038/oby.2010.289
Psychosocial predictors of eating disorder risk in overweight and obese treatment seeking adolescents
Russo, Jade, Brennan, Leah, Walkley, Jeff, Fraser, Steve and Greenway, Kate. (2011). Psychosocial predictors of eating disorder risk in overweight and obese treatment seeking adolescents. Behaviour Change. 28(3), pp. 111 - 127. https://doi.org/10.1375/bech.28.3.111
A pilot study of a telephone-based parental intervention to increase fruit and vegetable consumption in 3 to 5 year old children
Wyse, Rebecca, Wolfenden, Luke, Campbell, Elizabeth, Campbell, Karen, Brennan, Leah, Fletcher, Amanda, Bowman, Jenny, Heard, Todd and Wiggers, John. (2011). A pilot study of a telephone-based parental intervention to increase fruit and vegetable consumption in 3 to 5 year old children. Public Health Nutrition. 14(12), pp. 2245 - 2253. https://doi.org/10.1017/S1368980011001170
Reliability of the school food checklist for in-school audits and photograph analysis of children's school lunches
Mitchell, Sarah, Miles, Cara, Brennan, Leah and Matthews, Jan. (2010). Reliability of the school food checklist for in-school audits and photograph analysis of children's school lunches. Journal of Human Nutrition and Dietetics. 23(1), pp. 48 - 53. https://doi.org/10.1111/j.1365-277X.2009.00996.x
A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program : rationale and methodology
Burke, Kylie, Brennan, Leah and Roney, Sarah. (2010). A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program : rationale and methodology. Child and Adolescent Psychiatry and Mental Health. 4(22), pp. 1 - 14. https://doi.org/10.1186/1753-2000-4-22
Parental use of restrictive feeding practices and child BMI z-score. A 3-year prospective cohort study
Campbell, Karen, Andrianopoulos, Nick, Hesketh, Kylie, Ball, Kylie, Crawford, David, Brennan, Leah, Corsini, Nadia and Timperio, Anna. (2010). Parental use of restrictive feeding practices and child BMI z-score. A 3-year prospective cohort study. Appetite. 55(1), pp. 84 - 88. https://doi.org/10.1016/j.appet.2010.04.006
A cluster randomised trial of a telephone-based intervention for parents to increase fruit and vegetable consumption in their 3- to 5-year-old children: Study protocol
Wyse, Rebecca, Wolfenden, Luke, Campbell, Elizabeth, Brennan, Leah, Campbell, Karen, Fletcher, Amanda, Bowman, Jenny, Heard, Todd and Wiggers, John. (2010). A cluster randomised trial of a telephone-based intervention for parents to increase fruit and vegetable consumption in their 3- to 5-year-old children: Study protocol. BMC Public Health. 10(216), pp. 1 - 12. https://doi.org/10.1186/1471-2458-10-216
Adolescent and parent content preferences and predictors of intention to use an online healthy weight website for adolescents
Baulch, Jacqueline, Chester, Andrea and Brennan, Leah. (2010). Adolescent and parent content preferences and predictors of intention to use an online healthy weight website for adolescents. E - Journal of Applied Psychology. 6(1), pp. 19 - 26. https://doi.org/10.7790/ejap.v6i1.173
Changes in the content of children's school lunches across the school week
Brennan, Leah, Miles, Cara, Mitchell, Sarah and Matthews, Jan. (2010). Changes in the content of children's school lunches across the school week. Health Promotion Journal of Australia. 21(3), pp. 196 - 201.
Maternal psychosocial predictors of controlling parental feeding styles and practices
Mitchell, Sarah, Brennan, Leah, Hayes, Louise and Miles, Cara L.. (2009). Maternal psychosocial predictors of controlling parental feeding styles and practices. Appetite. 53(3), pp. 384 - 389. https://doi.org/10.1016/j.appet.2009.08.001
Health-related quality of life in obese children and adolescents
Tsiros, Margarita D., Olds, Timothy S., Buckley, Jonathan David, Grimshaw, Paul, Brennan, Leah, Walkley, Jeff, Hills, Andrew Peter, Howe, Peter and Coates, Alison M.. (2009). Health-related quality of life in obese children and adolescents. International Journal of Obesity. 33(4), pp. 387 - 400. https://doi.org/10.1038/ijo.2009.42
A cognitive behavioural intervention for overweight and obese adolescents illustrated by four case studies
Brennan, Leah, Walkley, Jeff, Lukeis, Sarah, Risteska, Anica, Archer, Lisa, Digre, Ellen, Fraser, Steve F. and Greenway, Kate. (2009). A cognitive behavioural intervention for overweight and obese adolescents illustrated by four case studies. Behaviour Change. 26(3), pp. 190 - 213. https://doi.org/10.1375/bech.26.3.190
Treatment alternatives for overweight and obesity: The role of online interventions
Baulch, Jacqueline, Chester, Andrea and Brennan, Leah. (2008). Treatment alternatives for overweight and obesity: The role of online interventions. Behaviour Change. 25(1), pp. 1 - 14. https://doi.org/10.1375/bech.25.1.1
Motivational interviewing and cognitive behaviour therapy in the treatment of adolescent overweight and obesity: Study design and methodology
Brennan, Leah, Walkley, Jeff, Fraser, Steve F., Greenway, Kate and Wilks, Ray. (2008). Motivational interviewing and cognitive behaviour therapy in the treatment of adolescent overweight and obesity: Study design and methodology. Contemporary Clinical Trials. 29(3), pp. 359 - 375. https://doi.org/10.1016/j.cct.2007.09.001
Cognitive behavioural therapy improves diet and body composition in overweight and obese adolescents
Tsiros, Margarita D., Parletta, Natalie, Brennan, Leah, Coates, Alison M., Walkley, Jeff, Petkov, John, Howe, Peter, David and Buckley, Jonathan David. (2008). Cognitive behavioural therapy improves diet and body composition in overweight and obese adolescents. American Journal of Clinical Nutrition. 87(5), pp. 1134 - 1140.