The Cycle Study: a Study of the Effectiveness of Cycling Exercise in Breaking the Cycle of Pregnancy Diabetes
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|ClinicalTrials.gov Identifier: NCT01283854|
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : March 2, 2015
Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy and has serious health implications for both the pregnant woman and her child. In particular, offspring of mothers with GDM have an increased prevalence of obesity, diabetes and metabolic syndrome, perpetuating serious health consequences in subsequent generations.
Although regular exercise offers numerous benefits for both the mother and her child, its effectiveness in preventing GDM remains to be established. It has been recently shown that regular supervised home-based exercise may attenuate the decline in glucose tolerance in obese pregnant women. This study aims to conduct a single-centred, multi-sited, single-blinded randomised controlled trial examining the effect of 14 weeks of supervised home-based exercise (commenced at 14 weeks gestation) on the recurrence and severity of GDM, along with other aspects of maternal and fetal wellbeing.
Eligible participants (n = 200) will be randomly allocated to an exercise intervention (n = 100) or a control group (n = 100). The exercise intervention will involve three 60-minute home-based, supervised exercise sessions each week. This type of program overcomes many of the barriers to exercise in this population including transportation, child care issues and embarrassment associated with exercising in a public venue. The investigators have already shown this program to be both feasible and warmly accepted by obese pregnant women.
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Mellitus||Behavioral: Supervised home-based exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preventing Gestational Diabetes Mellitus Using a Home-based Supervised Exercise Program During Pregnancy|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Exercise group
Each participant randomised to the exercise group will receive routine, regular antenatal care. In addition, these women will be required to participate in three 60-minute exercise sessions each week, starting at 14 weeks gestation, for a total of 14 weeks (i.e. to be completed by 28 weeks of gestation). All exercise sessions will be home-based and fully supervised by an experienced exercise physiologist.
Behavioral: Supervised home-based exercise
Each participant randomised to the exercise group will be required to participate in three 60-minute exercise sessions each week, starting at 14 weeks gestation, for a total of 14 weeks (i.e. to be completed by 28 weeks of gestation). All exercise sessions will be home-based and fully supervised by an experienced exercise physiologist. The exercise program will be implemented in accordance with the American College of Sports Medicine and the American College of Obstetrics and Gynecology guidelines. All sessions will be conducted on a stationary cycle ergometer.
Heart rate will be measured continuously during exercise to ensure that the exercise intensity is maintained as prescribed. In addition, blood pressure and rate of perceived exertion will be monitored at 10-min intervals. Perceived exertion will not be allowed to exceed a rating of 14 (i.e. "somewhat hard").
No Intervention: Control group
Women allocated to the control group will not participate in the home-based exercise program, and will continue their normal physical activity throughout pregnancy. This group will receive routine, regular antenatal care, together with the additional outcome assessments at baseline (14 weeks gestation) and cessation of the study (28 weeks gestation).
- Diagnosis of gestational diabetes mellitus [ Time Frame: After the 14 week intervention period (28 weeks gestation) ]
- Insulin sensitivity and glucose tolerance [ Time Frame: Pre and post-intervention (14 and 28 weeks of gestation) ]
- Maternal aerobic fitness levels [ Time Frame: Pre and post-intervention (14 and 28 weeks gestation) ]
- Maternal morphology (girths and skinfold measures) [ Time Frame: Pre and post-intervention (14 and 28 weeks gestation) ]
- Maternal mental health [ Time Frame: Pre and post-intervention (14 and 28 weeks gestation) ]
- Obstetric outcomes (rates of medical intervention during labour, birth weight, newborn anthropometrics and incidence of newborn hypoglycemia) [ Time Frame: At time of delivery (approximately 40 weeks gestation) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283854
|Australia, Western Australia|
|King Edward Memorial Hospital|
|Perth, Western Australia, Australia, 6008|
|Principal Investigator:||John Newnham||The University of Western Australia|
|Principal Investigator:||Paul Fournier||The University of Western Australia|
|Principal Investigator:||Kym Guelfi||The University of Western Australia|
|Principal Investigator:||Robert Grove||The University of Western Australia|
|Principal Investigator:||Karen Wallman||The University of Western Australia|
|Principal Investigator:||Dorota Doherty||Women and Infants Research Foundation|