Best Start - Weight Management During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 526
- 试验地点
- 8
- 主要终点
- Body Mass Index - Weight and height recordings will be used to calculate BMI in kg/m^2 at 12 weeks.
研究概览
简要总结
The investigators know that being overweight during pregnancy increases the health risks to both mum and baby. There is good evidence that diet or exercise, or both, during pregnancy can reduce excessive weight gain. The Best Start study aims to test the theory that obese pregnant women with a Body Mass Index (BMI) of 30 or over who participate in a structured programme of nutrition and lifestyle advice (Foodwise in Pregnancy ™) will achieve the recommended weight gain during pregnancy of no less than 5kg and no more than 9.1kg.
The investigators would like to find out if pregnant women with a BMI of 30 or over who receive the Best Start intervention are more likely to effectively manage weight gain during pregnancy. To achieve this, the investigators will undertake a trial that randomly puts participants into an experimental group, or a control group, which will compare those who receive the intervention to those who continue with routine antenatal care. The investigators are aiming to recruit around 500 women during the study period. 250 will receive the Best Start intervention, and 250 will continue with routine antenatal care.
The investigators would also like to find out if women who gain the recommended weight during pregnancy have better outcomes, compared to women who gain more or less weight. To do this the investigators will look at the routine information collected during antenatal and postnatal care, for both mum and baby. To do this regardless of the group clients are randomised to, the investigators will ask for permission to look at the routine information within the participants maternity record. This information includes, weight gained during pregnancy, whether the baby is born early, the type of labour and delivery, and any complications during the pregnancy or delivery that may have resulted in the need for additional care for mum or baby.
The results of the study will be prepared for publication in scientific journals, and for presentation at scientific conferences. All participants will be able to obtain a copy of the results once they have been published and any information that could identify participants will be removed.
详细描述
The intervention will invite obese pregnant women with a BMI ≥30 to participate in a research study where participants may be offered a programme of nutrition and lifestyle advice, unless participants meet the exclusion criteria.
The programme of nutrition and lifestyle advice will comprise a series of weekly 7 x 2 hour group sessions, which will be delivered in community venues by trained Healthy Lifestyle Support Workers (HLSWs) employed within the maternity service.
The group sessions will follow the scripted "Foodwise in PregnancyTM" manual of nutrition information; practical cooking sessions; and information on low impact exercise e.g. walking. 'Foodwise in PregnancyTM' has been developed by a group of NHS Dietitians and Midwives and is adapted from the existing Foodwise for Life programme. Pedometers will be provided at session three to raise participants awareness of the benefits of physical activity. The programme is participative in its approach to experiential learning.
The group sessions will also promote breastfeeding (All Wales Maternity Strategy Key Performance Indicator/Measure) to assist healthy weight gain for babies, healthy weaning and the importance of play and physical activity. Delivery of the sessions will be quality assured by a specialist public health dietitian and public health midwife employed within Cwm Taf University Health Board.
Because eligible women will initially be referred by a midwife, all midwives will be trained by a public health dietitian on the "Eating for 1, Healthy and Active for 2" Royal College of Midwives accredited compact training, to ensure a sensitive and effective conversation (using motivational interviewing techniques) that raises the issue of excess weight in pregnancy. The Healthy Lifestyle Support Workers, delivering the intervention, will also attend this training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of 30 or over and reside in Cwm Taf University Health Board area.
- •Aged over
- •Capable of giving informed consent.
- •Singleton and multiple pregnancies.
排除标准
- •Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of less than 29.9 and reside in Cwm Taf University Health Board area.
- •Aged under
- •Incapable of giving informed consent.
- •Any women who have pre-existing diabetes, or develop gestational diabetes during their pregnancy.
- •Any health condition that means the health professional looking after the patient feels would contra-indicate involvement in this programme (e.g. losing the ability to consent during the programme)
结局指标
主要结局
Body Mass Index - Weight and height recordings will be used to calculate BMI in kg/m^2 at 12 weeks.
时间窗: 12 weeks gestation.
Body Mass Index.
Weight of participant recorded in kg at 36 weeks.
时间窗: 36 weeks gestation.
The odds ratio of pregnant women with a BMI of ≥30 who do not gain excessive weight and achieve the optimum recommended weight gain during pregnancy of 5-9.1kg in the intervention group compared with the control group.
次要结局
- Number of participants identified with Thromboembolism - venous thromboembolism (VTE) - deep vein thrombosis(DVT) or pulmonary embolism (PE).(Participant booking appointment to 4 weeks postpartum.)
- Number of post programme interviews/focus groups with eligible participants, following a scripted questionnaire.(Programme completion, an average of 7 weeks.)
- Number of low birth weight babies born, weighing < 2.5kg.(At birth.)
- Number of Stillbirths.(24 weeks gestation to date of delivery.)
- Number of Neonatal deaths.(Date of birth to 28 days.)
- Number of participants Breastfeeding at birth, and exclusively breastfeeding at 10 days and 6 months.(Postnatal; Birth; 10 days and 6 months.)
- Self reported changes in study participants measured through a self completed questionnaire at the end of the weight management programme.(Programme completion, an average of 7 weeks.)
- Number of babies born Pre-term - babies born <37 weeks.(<37 weeks gestation)
- Number of participants referred to the study.(July 2017-September 2018.)
- Number of high birth weight babies born - Macrosomia.(At birth.)
- Percentage of weight management programme sessions attended by participants.(Programme completion, an average of 7 weeks.)
- Number of participants identified with Pre-eclampsia - New hypertension presenting after 20 weeks of pregnancy with significant proteinuria.(20 weeks +.)
- Number of participants identified with Postpartum haemorrhage (PPH); Primary and Secondary.(24 hours post-delivery to 12 weeks postpartum.)
- Mode of delivery - Caesarean section.(Date of delivery.)
- Post surgical site infection - a type of healthcare associated infection in which a wound infection occurs after an invasive (surgical) procedure.(Date of delivery to 4 weeks postpartum.)
- Number of babies born needing Neonatal intensive care unit (NICU) admission.(From birth to 14 days postpartum.)
- Number of babies born needing Transitional Care.(From birth to 14 days postpartum.)
- Rate of obesity in children born to study participants at age 4-5 years. Weight and height will be combined to calculate BMI in kg/m^2.(Age 4-5 years.)
- Acceptability of the programme to relevant staff groups - measured through semi-structured audio recorded interview (face-to-face or via telephone).(Up to 12 months.)