Gestational Diabetes MellitusNCT01283854
The Cycle Study: a Study of the Effectiveness of Cycling Exercise in Breaking the Cycle of Pregnancy Diabetes
A study testing Supervised home-based exercise in people with Gestational Diabetes Mellitus, run by The University of Western Australia at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Supervised home-based exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women at 12-13 weeks gestation, with a history of gestational diabetes in a previous pregnancy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
King Edward Memorial Hospital
Perth, Western Australia, 6008
About this study
Official title: 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Supervised home-based exercise
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised home-based exerciseBehavioural
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").
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Behavioral: Supervised home-based exercise |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of gestational diabetes mellitus
Measured: After the 14 week intervention period (28 weeks gestation)
Secondary outcomes (5)
Insulin sensitivity and glucose tolerance
Measured: Pre and post-intervention (14 and 28 weeks of gestation)
Maternal aerobic fitness levels
Measured: Pre and post-intervention (14 and 28 weeks gestation)
Maternal morphology (girths and skinfold measures)
Measured: Pre and post-intervention (14 and 28 weeks gestation)
Maternal mental health
Measured: 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)
Measured: At time of delivery (approximately 40 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- King Edward Memorial Hospital
- Responsible party
- Principal investigator, Kym Guelfi, The University of Western Australia
- Investigators
- John Newnham, Principal investigator, The University of Western AustraliaPaul Fournier, Principal investigator, The University of Western AustraliaKym Guelfi, Principal investigator, The University of Western AustraliaRobert Grove, Principal investigator, The University of Western AustraliaKaren Wallman, Principal investigator, The University of Western AustraliaDorota Doherty, Principal investigator, Women and Infants Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283854
- Sponsor's protocol ID
- 1003302_Newnham
- Status last verified
- Nov 2014
- First submitted
- 21 Jan 2011
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19747869Guelfi 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.
PubMed 27607876
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Gestational Diabetes Mellitus Using a Home-based Supervised Exercise Program During Pregnancy
- ClinicalTrials.gov ID
- NCT01283854
- Acronym / sponsor ID
- 1003302_Newnham
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- King Edward Memorial Hospital
- Study start
- Jun 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Supervised home-based exerciseEach 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. |
| Control group | No intervention | –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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women at 12-13 weeks gestation, with a history of gestational diabetes in a previous pregnancy.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised home-based exerciseEach 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"). | Behavioural | Exercise group |
Primary outcome
Diagnosis of gestational diabetes mellitus
Time frame: After the 14 week intervention period (28 weeks gestation)
5 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
- Background: PubMed 19747869Ong 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.
- Derived from this study: PubMed 27607876Guelfi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Newnham principal investigator
The University of Western Australia
Paul Fournier principal investigator
The University of Western Australia
Kym Guelfi principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised home-based exercise in people with Gestational Diabetes Mellitus, run by The University of Western Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of gestational diabetes mellitus (time frame: After the 14 week intervention period (28 weeks gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01283854, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.