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临床试验/NCT03307733
NCT03307733已完成不适用

Walking in Pregnancy (WiP) - a Social Networking Physical Activity Intervention for Pregnant Obese Women

Sheffield Hallam University0 个研究点目标入组 40 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Attrition

研究概览

简要总结

A physical activity feasibility randomised control trial for pregnant, obese women.

详细描述

Overweight (defined as BMI ≥25kg/m2) and obesity (defined as BMI ≥30kg/m2) during pregnancy is becoming more common. Approximately 25-30% of women of childbearing age are obese and around 50% are overweight at the time of conception. Women who are either overweight or obese have a much higher risk of adverse pregnancy outcomes. For example, they are more likely to develop gestational diabetes, pregnancy-induced hypertension, pre-eclampsia, Caesarean section and other complications. Recent research suggests that overweight and obese pregnant women are less active than normal weight ( BMI≤ 25kg/m2) pregnant women and also that the level of physical activity decreases throughout pregnancy. The evidence also suggests that maintaining a good level of physical activity can reduce the risks of adverse pregnancy outcomes. A large study which looked at the most preferred types of physical activity identified that walking and swimming were the most preferred types of physical activity by pregnant women. Although there is an association between walking at a brisk pace and a reduced risk of gestational diabetes, there is no definitive conclusion on the effectiveness of walking interventions. The investigators are proposing this feasibility study in order to find out whether a walking intervention can be implemented during pregnancy in the obese population to reduce adverse pregnancy health outcomes. The current study will investigate whether a Fitibit Pedometer and a Social networking Site (Facebook) can be used to encourage pregnant, obese women to increase and maintain activity during pregnancy. The feasibility study will test the recruitment strategy, acceptability of the intervention design, randomisation acceptability, and timing of the intervention. Participants from both the control and the intervention will be purposefully selected to take part in focus group following the intervention in order to give feedback on the study. The investigators will be working with an Obstetrics & Gynaecology consultant at Jessop Wing, Hallamshire Hospital to help with the recruitment process and provide clinical advice. Women who are obese (BMI>30kg/m2) in their early pregnancy (12-14 weeks) will be recruited. Participants that consent to take part in the study will be given a Fitbit pedometer and enrolled in a closed Facebook group. Each participant will wear a Fitbit for a week in order to measure their baseline physical activity level. Thereafter, the participants in the intervention will be asked to gradually increase their physical activity level (they will be given a weekly step target)for 4 weeks in total. The Facebook component of the intervention will contain motivational and educational posts and rewarding messages about their progress. The control group will be asked to wear a Fitbit for 5 weeks and do their usual activities in total with a covered screen so as to not see the step count

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
None

盲法说明

It is difficult to mask in these type of interventions.

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

  • pregnant 11-14 weeks gestation
  • BMI >30kg/m2
  • No known risks or complications
  • Able to walk

排除标准

  • High risk of miscarriage

结局指标

主要结局

Attrition

时间窗: 5 weeks

Drop out rate will be calculated by simple descriptive statistics.

Compliance

时间窗: 5 weeks

Compliance to the study procedures will be calculated by simple descriptive. statistics

Adherence rates

时间窗: 5 weeks

Adherence to Fitbit will be measured daily.

Recruitment

时间窗: 5 weeks

Recruitment rate will be calculated by simple descriptive statistics. (number of participants approached vs. number of participants that agree to take part)

次要结局

  • gestational diabetes status(26 weeks)
  • Birth weight(At delivery ( 9 months roughly))
  • Pregnancy and Birth outcomes(9 months)
  • Apgar score(At delivery ( 9 months roughly))
  • Gestational Weight Gain(5 weeks)
  • C-section(9 months)

研究者

申办方类型
Other
责任方
Sponsor

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