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

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Behavioral: Supervised home-based exercise

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia, 6008
      • King Edward Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of gestational diabetes mellitus	After the 14 week intervention period (28 weeks gestation)

Secondary Outcome Measures

Outcome Measure	Time Frame
Insulin sensitivity and glucose tolerance	Pre and post-intervention (14 and 28 weeks of gestation)
Maternal aerobic fitness levels	Pre and post-intervention (14 and 28 weeks gestation)
Maternal morphology (girths and skinfold measures)	Pre and post-intervention (14 and 28 weeks gestation)
Maternal mental health	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)	At time of delivery (approximately 40 weeks gestation)

Collaborators and Investigators

• Sponsor: The University of Western Australia
• Collaborators: King Edward Memorial Hospital
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• Guelfi KJ, Ong MJ, Crisp NA, Fournier PA, Wallman KE, Grove JR, Doherty DA, Newnham JP. Regular Exercise to Prevent the Recurrence of Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):819-827. doi: 10.1097/AOG.0000000000001632.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): March 2, 2015
• Last Update Submitted That Met QC Criteria: February 27, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 1003302_Newnham