The Cycle Study: a Study of the Effectiveness of Cycling Exercise in Breaking the Cycle of Pregnancy Diabetes

Gestational Diabetes Mellitus Clinical Trial

Official title:

Preventing Gestational Diabetes Mellitus Using a Home-based Supervised Exercise Program During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283854
• Other study ID #: 1003302_Newnham
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: February 27, 2015
• Start date: June 2011
• Est. completion date: February 2015

Study information

• Verified date: November 2014
• Source: The University of Western Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• women at 12-13 weeks gestation, with a history of gestational diabetes in a previous pregnancy.

Exclusion Criteria:

• unable to participate in the supervised 14 week home-based exercise program

• less than 18 years of age

• unable to understand the implications of participation in the trial

• women with a multiple pregnancy

• women with pre-existing diabetes (type 1 or 2) or cardiac disease

• women currently engaged in a structured exercise program

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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").

Locations

Country	Name	City	State
Australia	King Edward Memorial Hospital	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
The University of Western Australia	King Edward Memorial Hospital

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Ong MJ, Guelfi KJ, Hunter T, Wallman KE, Fournier PA, Newnham JP. Supervised home-based exercise may attenuate the decline of glucose tolerance in obese pregnant women. Diabetes Metab. 2009 Nov;35(5):418-21. doi: 10.1016/j.diabet.2009.04.008. Epub 2009 Sep 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of gestational diabetes mellitus		After the 14 week intervention period (28 weeks gestation)	No
Secondary	Insulin sensitivity and glucose tolerance		Pre and post-intervention (14 and 28 weeks of gestation)	No
Secondary	Maternal aerobic fitness levels		Pre and post-intervention (14 and 28 weeks gestation)	No
Secondary	Maternal morphology (girths and skinfold measures)		Pre and post-intervention (14 and 28 weeks gestation)	No
Secondary	Maternal mental health		Pre and post-intervention (14 and 28 weeks gestation)	No
Secondary	Obstetric outcomes (rates of medical intervention during labour, birth weight, newborn anthropometrics and incidence of newborn hypoglycemia)		At time of delivery (approximately 40 weeks gestation)	No