Outcomes of Pregnant Barbadian Women With Obesity: A Case Controlled Prospective Study of Didactic Dietary Intervention Compared to a Standard Education Tool
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 172
- 主要终点
- Mean change in gestational weight in kilograms in each arm of the trial
研究概览
简要总结
The researcher will study a group of pregnant Barbadians with BMI at booking of greater than or equal to 35. All of the women will be given leaflets telling them about healthy diets in pregnancy and how to limit weight gain. Half of the women will be sent to the dietitian for small group classes on diet and how to limit weight gain. The two groups of women will be compared to see which group gains more weight and which group has more complications during the pregnancy.
详细描述
More than 2100 pregnant women per annum deliver their babies at the Queen Elizabeth Hospital, the lone publicly-funded hospital providing secondary and tertiary-level obstetric care in Barbados. Routinely recorded data do not capture whether patients are overweight or obese. Thus, the prevalence of obesity is not known amongst this population. Additionally, these women are not routinely referred for dietician services, and thus the impact of dietician intervention is not known. The aim of this research is to determine whether a dietitian-led intervention could lead to decreased gestational weight gain and less incidence of foetal macrosomia in a sample of Barbadian women, with class II obesity, attending a public antenatal clinic. Prior studies examining gestational weight gain, found no statistically significance between groups when a BMI of 30 was used. It is hoped that by using a group with higher obesity a larger difference will be seen with the intervention. Participants with body mass index greater than 35kg/m^2 who meet the eligibility criteria will be selected from one of five antenatal clinics at the Queen Elizabeth Hospital on the island of Barbados. They will be randomised to either receive didactic dietary sessions or a standard education tool. Mean weight change will be compared amongst the two groups after delivery to determine if there was a decrease in gestational weight gain amongst the intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman over 18 years old
- •Live singleton pregnancy
- •BMI of greater than or equal to 35kg/m^2
- •Registered patient of the Queen Elizabeth Hospital Antenatal Clinic
排除标准
- •Presence of gestational diabetes or chronic diabetes mellitus,
- •Have had bariatric surgery
- •Do not speak english
- •Pregnancy with a multiple gestation.
结局指标
主要结局
Mean change in gestational weight in kilograms in each arm of the trial
时间窗: From enrolment until delivery
Weight at or before delivery minus weight at enrolment
次要结局
- Incidence of gestational diabetes in each arm of the trial(Beyond 20 weeks gestation and prior to delivery)
- Mean neonatal birth weight in grams in each arm of the trial(Within one hour of birth)
- Incidence of primary post partum haemorrhage in each arm of the trial(Within 24 hours of delivery)
- Incidence of low one minute APGAR score in each arm of the trial(After one minute of birth)
- Incidence of pregnancy induced hypertension in each arm of the trial(Beyond 20 weeks gestation and prior to delivery)
研究者
Tonya Johnson
Doctor
The University of The West Indies