Preventing Gestational Diabetes Mellitus Using a Home-based Supervised Exercise Program During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Diagnosis of gestational diabetes mellitus
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women at 12-13 weeks gestation, with a history of gestational diabetes in a previous pregnancy.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Supervised home-based exercise (Behavioral)
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).
结局指标
主要结局
Diagnosis of gestational diabetes mellitus
时间窗: After the 14 week intervention period (28 weeks gestation)
次要结局
- 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))
研究者
Kym Guelfi
Assistant Professor Kym Guelfi
The University of Western Australia