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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01283854




Registration number
NCT01283854
Ethics application status
Date submitted
21/01/2011
Date registered
26/01/2011
Date last updated
2/03/2015

Titles & IDs
Public title
The Cycle Study: a Study of the Effectiveness of Cycling Exercise in Breaking the Cycle of Pregnancy Diabetes
Scientific title
Preventing Gestational Diabetes Mellitus Using a Home-based Supervised Exercise Program During Pregnancy
Secondary ID [1] 0 0
1003302_Newnham
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Supervised home-based exercise

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.

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).


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").
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnosis of gestational diabetes mellitus
Timepoint [1] 0 0
After the 14 week intervention period (28 weeks gestation)
Secondary outcome [1] 0 0
Insulin sensitivity and glucose tolerance
Timepoint [1] 0 0
Pre and post-intervention (14 and 28 weeks of gestation)
Secondary outcome [2] 0 0
Maternal aerobic fitness levels
Timepoint [2] 0 0
Pre and post-intervention (14 and 28 weeks gestation)
Secondary outcome [3] 0 0
Maternal morphology (girths and skinfold measures)
Timepoint [3] 0 0
Pre and post-intervention (14 and 28 weeks gestation)
Secondary outcome [4] 0 0
Maternal mental health
Timepoint [4] 0 0
Pre and post-intervention (14 and 28 weeks gestation)
Secondary outcome [5] 0 0
Obstetric outcomes (rates of medical intervention during labour, birth weight, newborn anthropometrics and incidence of newborn hypoglycemia)
Timepoint [5] 0 0
At time of delivery (approximately 40 weeks gestation)

Eligibility
Key inclusion criteria
* women at 12-13 weeks gestation, with a history of gestational diabetes in a previous pregnancy.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
King Edward Memorial Hospital - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
King Edward Memorial Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01283854
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
John Newnham
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01283854