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

This study is currently recruiting participants.
Verified March 2012 by The University of Western Australia
Sponsor:
Collaborator:
King Edward Memorial Hospital
Information provided by (Responsible Party):
Kym Guelfi, The University of Western Australia
ClinicalTrials.gov Identifier:
NCT01283854
First received: January 21, 2011
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Gestational Diabetes Mellitus
 Behavioral: Supervised home-based exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Gestational Diabetes Mellitus Using a Home-based Supervised Exercise Program During Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • Diagnosis of gestational diabetes mellitus [ Time Frame: After the 14 week intervention period (28 weeks gestation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin sensitivity and glucose tolerance [ Time Frame: Pre and post-intervention (14 and 28 weeks of gestation) ] [ Designated as safety issue: No ]
  • Maternal aerobic fitness levels [ Time Frame: Pre and post-intervention (14 and 28 weeks gestation) ] [ Designated as safety issue: No ]
  • Maternal morphology (girths and skinfold measures) [ Time Frame: Pre and post-intervention (14 and 28 weeks gestation) ] [ Designated as safety issue: No ]
  • Maternal mental health [ Time Frame: Pre and post-intervention (14 and 28 weeks gestation) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283854

Contacts
Contact: John Newnham JNewnham@obsgyn.uwa.edu.au
Contact: Kym Guelfi kym.guelfi@uwa.edu.au

Locations
Australia, Western Australia
King Edward Memorial Hospital Recruiting
Perth, Western Australia, Australia, 6008
Contact: John Newnham         John.Newnham@uwa.edu.au    
Contact: Kym Guelfi         kym.guelfi@uwa.edu.au    
Sponsors and Collaborators
The University of Western Australia
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
  More Information

Publications:

Responsible Party: Kym Guelfi, Assistant Professor Kym Guelfi, The University of Western Australia
ClinicalTrials.gov Identifier: NCT01283854     History of Changes
Other Study ID Numbers: 1003302_Newnham
Study First Received: January 21, 2011
Last Updated: March 14, 2012
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013