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临床试验/NCT06882837
NCT06882837尚未招募不适用

Body Weight Awareness and SUpport for Mums During Pregnancy (BUMP2.0): a Feasibility Study

University of Oxford1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Percentage of participants in the BUMP app group who log their weight on at least half of all weeks of their participation

研究概览

简要总结

Most women in the UK gain more weight than recommended during pregnancy, which puts them and their babies at risk of medical complications. Studies which have interviewed women during pregnancy have shown that they recognise that controlling their weight is important, but this is rarely discussed with their clinical team. Some women reported they expected to be weighed during pregnancy, and that regular weighing should be part of routine antenatal care, but it is not. Trials which have trained midwives to regularly weigh women or to ask women to regularly weigh themselves, have not shown beneficial effects on gestational weight gain. However, these trials were either small, or reported low protocol adherence, or did not offer adequate feedback and advice in response to weight gain. A few programmes to manage weight during pregnancy have been effective, but were costly and burdensome for women. Regular self-weighing has been shown to be an effective strategy for weight control outside of pregnancy, and if it can be enacted in pregnancy and help manage weight gain, it could improve health outcomes for women and their babies.

The investigators have developed a mobile app to support women to weigh themselves regularly during pregnancy and track their weight gain, to provide feedback on whether weight gain is within, higher, or lower than recommended ranges, and to signpost to resources on weight management during pregnancy. The trial aims to test if it is possible to motivate participants to regularly weigh themselves during pregnancy and how well they engage with the app from early or mid-pregnancy until delivery. The investigators will also examine whether the processes of the study run as planned, whether there is an indication of an impact of the programme on gestational weight gain compared to a control group, and will explore participants' experiences of using the app through optional qualitative interviews. If feasible, after completion of this study, the next step will be a bigger trial to investigate whether this app-based programme is effective in helping women manage their weight gain and improve health outcomes during pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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
否

入选标准

  • •Pregnant women at <20 weeks' gestation
  • •18 years of age or above
  • •Singleton pregnancy
  • •18 years of age or above
  • •Able to access the internet with a smartphone and/or tablet
  • •Have access to weighing scales
  • •Able to communicate in English

排除标准

  • 未提供

研究组 & 干预措施

BUMP app

Experimental

干预措施: BUMP app (Behavioral)

Usual care

No Intervention

No intervention

结局指标

主要结局

Percentage of participants in the BUMP app group who log their weight on at least half of all weeks of their participation

时间窗: From randomization which can happen any time between the start of pregnancy and 20 weeks of pregnancy, until the end of the study for each participant, which is the date on which a participant gives birth, usually at 40-42 weeks of pregnancy.

Percentage of participants in the BUMP app group who spontaneously log a weight measurement into the app at later stages of pregnancy

时间窗: Late stages of pregnancy, defined as the time frame between 34 weeks of pregnancy and the date on which a participant gives birth usually at 40-42 weeks of pregnancy.

Overall retention rate at study follow-up

时间窗: Late stages of pregnancy, defined as the time frame between 34 weeks of pregnancy and the date on which a participant gives birth usually at 40-42 weeks of pregnancy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DrMoschoMichalopoulou

Post-doctoral Researcher - Behavioural Scientist

University of Oxford

研究点 (1)

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