Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Physical activity
研究概览
简要总结
This study evaluate the efficacy of an App for monitoring the physical activity and weight with a smart watch and the provision of virtual advice through messages with a mobile phone in obese pregnant women in the second trimester.
Half of the women will be randomized at the intervention group (App + smart watch) and the other half, to the control group who will receive the usual prenatal care.
详细描述
Randomized controlled trial among obese women. These women will be randomized in two groups in order to evaluate an improvement in several outcomes thanks to different strategies:
Intervention group (IG). An App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care.
Control group. Pregnant women will receive the usual prenatal care. Main hypothesis: In the intervention group pregnant women will improve the weight gain adjusted to the preconception BMI, during pregnanacy, with respect to the pregnant women of the control group.
Secondary hypothesis. In the intervention group pregnant women will improve the physical activity.
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
- Single (Care Provider)
盲法说明
Care provider will not know the arm of randomization
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 with BMI ≥ 30 Kg / m2 preconceptional
- •Speak Spanish fluently
- •Viable singleton non-malformed fetus
- •12-18 weeks of gestation
- •Users of Android or Iphone smart mobile phone with internet connection
排除标准
- •Pregnant women users of a physical activity and weight monitoring App
- •Pregnant women with Type I or II Diabetes Mellitus
- •Pregnant Women with psychiatric disorders
- •Pregnant women with thyroid disorders
- •Women with chronic hypertension
- •Pregnant women who for some reason have contraindicated the performance of exercise or mobility problems that make it impossible to walk in a moderate way.
- •Pregnant women who do not accept to participate in the study.
结局指标
主要结局
Physical activity
时间窗: 36 weeks
METS/minutes/week by the "IPAQ Scale" short version
Gestational weight gain
时间窗: 36 weeks
Compare gestational weight gain dring pregnancy in both groups.
次要结局
- Intrapartum complications(Labor)
- perinatal complications(birth)
- Gestational complications(36 weeks)
研究者
Elena Gonzalez-Plaza
Midwife
Hospital Clinic of Barcelona