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临床试验/NCT01770522
NCT01770522已完成不适用

A Longitudinal Study Exploring Factors Influencing Weight Gain During Pregnancy and Subsequent Weight Loss and Retention up to One Year Postpartum

University of Nottingham1 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
368
试验地点
1
主要终点
Weight change during pregnancy and postnatal period

研究概览

简要总结

It is well known that being overweight or obese increases the risk of health problems, and that many people find it difficult to maintain a healthy weight. Worryingly the rise in obesity is greater in women than in the male population. One possible reason for this is that some women gain too much weight during their pregnancy and find it difficult to lose this weight after the birth of their baby. For example, women who gain more weight than recommended during pregnancy have been shown to be more likely to carry excess that weight at 1 and 15 years after pregnancy, compared to women who gained the recommended amount of weight.

There are currently no evidence-based guidelines in the UK for how weight should be managed during pregnancy. For these reasons, it is really important that we understand the factors affecting weight management before, during and after pregnancy.

The aim of this research is therefore to find successful approaches to help women manage their weight before, during and after pregnancy. This will be completed by understanding the knowledge, attitudes, experiences and expectations of women during and after pregnancy and to identify the factors (e.g. diet, physical activity, poor social network etc.) which influence body weight. This will enable us to suggest better strategies for promoting healthy weight changes during and after pregnancy.

详细描述

Obesity in women of reproductive age is a major factor facing primary and secondary healthcare provision, with half of women of childbearing age in the UK classified as overweight or obese (The Information Centre, 2008). The prevalence of obesity in pregnant women living in Nottingham City is estimated to be 18.4%, (Wilcox, 2011), compared to 15.5% in England as a whole (Heslehurst et al., 2010). Being overweight or obese during pregnancy increases the risk of morbidity and mortality attributed to a range of pregnancy-related complications (Galtier et al, 2008), with 49% of maternal deaths occurring in overweight or obese women (Cantwell et al., 2011). Women who are overweight or obese at conception are more likely to develop hypertensive or diabetic complications, to develop thrombosis, and to deliver macrosomic babies (Ramachenderan et al, 2008). Associated with this are increased rates of delivery complications, postpartum haemorrhage and caesarean section (Galtier et al., 2008), with obese women at greater risk of anaesthetic complications. There is also a greater risk of infections (Metwally et al, 2007). Risks posed to the baby include congenital abnormalities such as spina bifida and oral clefts (King, 2006), and an increased risk of childhood obesity and adult metabolic syndrome (Galtier et al, 2008). The societal and economic impact of obesity during pregnancy is therefore life-long.

Excessive weight gain during pregnancy has little positive effect on foetal growth and pregnancy duration (Scholl et al, 1995) and is associated with a similar range of adverse outcomes as described above (Guelinckx et al., 2008). It is also associated with a greater probability of post-partum weight retention. Linné et al (2004) showed that both normal weight and overweight/obese women who gained excessive weight were more likely to have retained more weight 1 and 15 years after pregnancy, compared to women who gained the recommended amount of weight during pregnancy.

Whilst the US Institute of Medicine recommends lower pregnancy weight gain ranges for overweight and obese women (IOM, 2009), there are currently no UK evidence based guidelines outlining an appropriate BMI-specific weight gain (NICE, 2009). The current UK guide for weight gain is 10 - 12.5kg for all women (DoH, 2009). There is concern expressed that women are not being informed of the risks associated with obesity during pregnancy, or of the importance of a safe weight gain during pregnancy (NICE, 2009).

A study on the views of health professionals highlighted the issue that dietary information is often ad-hoc, and that advice is not linked with weight management (Heslehurst et al, 2007). Wiles (1998) found that above average weight women felt they didn't receive relevant weight management information. NICE (2010) recommended that there was need for research to find effective and cost effective approaches to help women manage their weight before, during and after pregnancy, including those from disadvantaged, low income and minority ethnic groups. In order to develop better strategies for promoting healthy weight changes in this population, it is important to understand the knowledge, attitudes and beliefs, experience and expectations of pregnant women during and after pregnancy in relation to their body weight and the behavioural factors which influence body weight. However, there is a paucity of research in this field. A recent systematic review (Campbell, et al, 2008) identified just 8 studies, (in the UK since 1990, with the most recent being conducted in 2004), into the views and attitudes to diet, physical activity and weight gain in pregnancy.

Childbearing may affect attitudes towards body image and this psychological dimension of weight is also important in understanding postpartum weight retention. Relatively few studies have investigated the effects of risk factors on weight retention in postpartum women. Gaining this intelligence from representative population groups is necessary for the selection and development of effective strategies to aid the development and commissioning of services and pathways to help address maternal obesity and post partum weight management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants will be pregnant women at 12 or 20 weeks pregnancy attending the 12 and 20 week antenatal scanning clinics at the Queens Medical Centre, Nottingham
  • Participants will be able to give informed consent- Participants will be over the age of 18
  • Participants will be able to read English - due to the nature of the study we will not be able to print the questionnaires in various languages.
  • Participants will be of any sociodemographic backgrounds, bodyweights and parity.

排除标准

  • Participants who do not feel that their literacy or English language skills will enable them to complete the questionnaires will be offered the opportunity to have one of the research team read the questions and fill in the answers for them. Whilst doing this and being sensitive to literacy and language issues, the nature of this feasibility study means that the research team will not offer an interpreting service or produce documents in languages other than English.
  • Participants will be excluded from the postnatal phase of the study if they deliver their baby prematurely (before 37 weeks of gestation) or do not give birth to a live baby. These exclusions are required, as premature birth or fetal loss/still birth would be expected to have an impact on psychological and physiological aspects linked to weight management which are not relevant to our specific research objectives. Information on birth outcome will be gained by accessing hospital records, and only women who have given birth to a live baby after 37 weeks of gestation will be contacted by the study team in the postnatal period.

结局指标

主要结局

Weight change during pregnancy and postnatal period

时间窗: 18 months +/- 2 months

To determine the weight change during pregnancy and postnatal period related to pre-pregnancy weight

次要结局

  • Secondary outcomes(18 months +/- 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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