Clinical trial NCT01283854: The Cycle Study: a Study of the Effectiveness of Cycling Exercise in Breaking the Cycle of Pregnancy Diabetes
Official title: Preventing Gestational Diabetes Mellitus Using a Home-based Supervised Exercise Program During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
Collaborators: name: King Edward Memorial Hospital
First posted: 2011-01-26
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Diagnosis of gestational diabetes mellitus
timeFrame: After the 14 week intervention period (28 weeks gestation)
Secondary outcomes:
measure: Insulin sensitivity and glucose tolerance
timeFrame: Pre and post-intervention (14 and 28 weeks of gestation)
measure: Maternal aerobic fitness levels
timeFrame: Pre and post-intervention (14 and 28 weeks gestation)
measure: Maternal morphology (girths and skinfold measures)
timeFrame: Pre and post-intervention (14 and 28 weeks gestation)
measure: Maternal mental health
timeFrame: Pre and post-intervention (14 and 28 weeks gestation)
measure: Obstetric outcomes (rates of medical intervention during labour, birth weight, newborn anthropometrics and incidence of newborn hypoglycemia)
timeFrame: At time of delivery (approximately 40 weeks gestation)
Other outcomes:
Locations:
city: Perth
country: Australia
facility: King Edward Memorial Hospital
state: Western Australia
Study officials:
affiliation: The University of Western Australia
name: John Newnham
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Paul Fournier
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Kym Guelfi
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Robert Grove
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Karen Wallman
role: PRINCIPAL_INVESTIGATOR
affiliation: Women and Infants Research Foundation
name: Dorota Doherty
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.