Graceful Lifestyle Changes Study for PCOS and Infertility
GLC
Graceful Lifestyle Changes Intervention Study for Women With PCOS and Infertility
1 other identifier
interventional
240
0 countries
N/A
Brief Summary
The purpose of this study is to help women with PCOS to improve their symptoms and ovulation rate through a lifestyle intervention program which introduces a specific diet, a physical activity regimen and mindfulness exercises to improve psychological well-being and overall health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
November 30, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedDecember 15, 2015
December 1, 2015
2.2 years
November 30, 2015
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ovulation Occurence
Ovulation is the primary outcome and expressed as any ovulation (categorical "yes" or "no") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.
12 weeks
Ovulation Frequency
Ovulation is the primary outcome can be expressed in according to frequency (nominal "0", "1", "2, or "3") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.
12 weeks
Secondary Outcomes (5)
Conception
12 weeks
Stress
12 weeks
Anxiety
12 weeks
Depression
12 weeks
Quality of Life
12 weeks
Study Arms (4)
Graceful Lifestyle Changes & MYO
EXPERIMENTALThe 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness. In addition, this group will take myo-inositol (6 grams in juice or water every morning).
Graceful Lifestyle Changes
EXPERIMENTALThe 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness. In addition, this group will take a white powder placebo (6 grams in juice or water every morning).
Letrozole & MYO
PLACEBO COMPARATORThe women assigned to the fertility medication group will be prescribed letrozole. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved. In addition, this group will take myo-inositol (6 grams in juice or water every morning).
Letrozole
PLACEBO COMPARATORThe women assigned to the fertility medication group will be prescribed letrozole. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved. In addition, this group will take a white powder placebo (6 grams in juice or water every morning).
Interventions
Participants will be educated in small groups of 8-10. A wellness booklet designed by physicians and researchers at Grace Fertility Centre will be provided.The target diet for our study is 45% carbohydrates and 55 grams of glycemic load. Participants will keep a 3-day food diary at baseline, 4, 8 and 12 weeks. Secondly, participants will be provided a pedometer and a goal to reach 10,000 steps a day. The third aspect of the program will be to decrease overall stress through mindfulness. Educational sessions will be held to teach the relaxation response and meditation techniques such as breathing and grounding exercises. Participants will be required to meditate for at least 20 minutes each day and record this.
Myo-inositol will be consumed in juice or water every morning (6 grams) for 12 weeks.
Letrozole will be administered to patients. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.
Eligibility Criteria
You may qualify if:
- all women with PCOS trying to conceive who are between 18 and 37 years of age (PCOS will be defined using the Rotterdam criteria)
You may not qualify if:
- women who have already began fertility treatment
- women who are taking myo-inositol or have taken it in the past three months
- women being treated for or who have a history of an eating disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (10)
Barr S, Reeves S, Sharp K, Jeanes YM. An isocaloric low glycemic index diet improves insulin sensitivity in women with polycystic ovary syndrome. J Acad Nutr Diet. 2013 Nov;113(11):1523-1531. doi: 10.1016/j.jand.2013.06.347. Epub 2013 Aug 30.
PMID: 23999280BACKGROUNDBarnard L, Ferriday D, Guenther N, Strauss B, Balen AH, Dye L. Quality of life and psychological well being in polycystic ovary syndrome. Hum Reprod. 2007 Aug;22(8):2279-86. doi: 10.1093/humrep/dem108. Epub 2007 May 30.
PMID: 17537782BACKGROUNDCostantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10.
PMID: 19499845BACKGROUNDDunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997 Dec;18(6):774-800. doi: 10.1210/edrv.18.6.0318.
PMID: 9408743BACKGROUNDHutchison SK, Stepto NK, Harrison CL, Moran LJ, Strauss BJ, Teede HJ. Effects of exercise on insulin resistance and body composition in overweight and obese women with and without polycystic ovary syndrome. J Clin Endocrinol Metab. 2011 Jan;96(1):E48-56. doi: 10.1210/jc.2010-0828. Epub 2010 Oct 6.
PMID: 20926534BACKGROUNDLudwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available.
PMID: 18799450BACKGROUNDMatchim Y, Armer JM, Stewart BR. Effects of mindfulness-based stress reduction (MBSR) on health among breast cancer survivors. West J Nurs Res. 2011 Dec;33(8):996-1016. doi: 10.1177/0193945910385363. Epub 2010 Oct 18.
PMID: 20956583BACKGROUNDPapaleo E, Unfer V, Baillargeon JP, De Santis L, Fusi F, Brigante C, Marelli G, Cino I, Redaelli A, Ferrari A. Myo-inositol in patients with polycystic ovary syndrome: a novel method for ovulation induction. Gynecol Endocrinol. 2007 Dec;23(12):700-3. doi: 10.1080/09513590701672405. Epub 2007 Oct 10.
PMID: 17952759BACKGROUNDUnfer V, Carlomagno G, Dante G, Facchinetti F. Effects of myo-inositol in women with PCOS: a systematic review of randomized controlled trials. Gynecol Endocrinol. 2012 Jul;28(7):509-15. doi: 10.3109/09513590.2011.650660. Epub 2012 Feb 1.
PMID: 22296306BACKGROUNDCutler DA, Shaw AK, Pride SM, Bedaiwy MA, Cheung AP. A randomized controlled trial comparing lifestyle intervention to letrozole for ovulation in women with polycystic ovary syndrome: a study protocol. Trials. 2018 Nov 16;19(1):632. doi: 10.1186/s13063-018-3009-5.
PMID: 30445999DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony P Cheung, MBBS MPH MBA
Grace Fertility Centre & Reproductive Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2015
First Posted
December 15, 2015
Study Start
December 1, 2015
Primary Completion
March 1, 2018
Study Completion
August 1, 2018
Last Updated
December 15, 2015
Record last verified: 2015-12