Improving Perinatal Outcomes Through Activity and Sleep Tracking
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Reduction in Perceived Maternal Stress
研究概览
简要总结
Purpose: The investigators hypothesize that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women reduce their stress during pregnancy.
Participants: Pregnant women enrolled in prenatal care at the University of North Carolina who have a documented moderate or high level of perceived stress ( ≥ 14) and are at high risk for adverse pregnancy outcomes due to body mass index of ≥ 30 kg/m2 or history of gestational hypertension, preeclampsia, intrauterine growth restriction, or preterm birth <37 weeks' in a prior pregnancy.
Procedures: Women meeting inclusion criteria will be recruited through the University of North Carolina prenatal care clinics. They will be contacted for possible participation at regularly scheduled prenatal visits and/or ultrasound. They may also be contacted for possible participation by remote methods (e.g., Telehealth). Women who are enrolled will complete validated dietary, stress, sleep, and body image questionnaires. Enrolled women will then be randomized to receive standard obstetrical care or enhanced counseling. All participants will receive a wrist-based activity tracker. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Maternal and neonatal outcomes will be compared between groups.
详细描述
During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to minimize stress and optimize weight gain, nutrition, and activity, positively impacting outcomes and lifelong health. The overarching hypothesis of this study is that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women increase their activity level during pregnancy, reduce stress, and optimize gestational weight gain and biometric parameters. Importantly, the investigators propose that women can be engaged in care via a simple, personalized text-message based intervention.
Women will be enrolled early in pregnancy and followed prospectively. All women will receive a wrist-based activity tracker. Some women (those randomized to receive individualized counseling) will receive weekly text messages based on their activity and sleep in the prior week. Other women will not receive any specific instructions regarding activity level. The investigators will follow their outcomes prospectively. Biologic samples (including blood, urine, vaginal swabs, placental tissue) will be collected at enrollment and at delivery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At high risk for adverse pregnancy outcomes, due to either body mass index ≥ 30 kg/m^2, or a prior history of preeclampsia, intrauterine growth restriction or preterm birth prior to 37 weeks' gestation in a previous pregnancy and a perceived stress score of >/= 14 (10-question scale)
- •Gestational age of 8.0 to 19.9 weeks' gestation using American College of Obstetricians and Gynecologists dating criteria (combination of ultrasound and menstrual dating, as available)
- •Current singleton viable intrauterine pregnancy. Spontaneous reduction of twin to singleton gestation is allowable provided it occurred prior to 14 weeks' gestation.
- •No structural abnormalities or aneuploidy
- •Ability to communicate in and provide consent in English
- •Maternal age 18 to 51 years of age
- •Owns smartphone compatible with wrist-based activity tracker (over 200 devices supported)
排除标准
- •Women pregnant with multifetal gestations
- •Women who have a medical condition where a modest increase in low-impact activity is contraindicated (at the discretion of the woman's treating physician)
- •Planned delivery prior to 36 weeks' of gestation
- •Unwilling to wear wrist-based activity tracker for at least 6 out of 7 days per week
研究组 & 干预措施
Usual care
Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy.
Activity Intervention
Women randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. .
干预措施: Activity Intervention (Behavioral)
结局指标
主要结局
Reduction in Perceived Maternal Stress
时间窗: through delivery, an average of 7 months per participant
Perceived stress score will be calculated using a validated 10-question stress scale; score = 14 indicates moderate stress
Proportion of women with adverse perinatal outcomes
时间窗: outcome will be ascertained at delivery
The investigators will define adverse pregnancy outcomes as a composite of preterm birth \<37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups.
次要结局
- Mean Resting heart rate parameters(through delivery, an average of 7 months per participant)
- Number of activity goals met by personalized activity level group(through delivery, an average of 7 months per participant)
- Median Daily steps(through delivery, an average of 7 months per participant)
- Mean Daily steps(through delivery, an average of 7 months per participant)
- Proportion of women with hypertensive complications of pregnancy(through 6 weeks' postpartum, an average of 7 months per participant)
- Median 'Moderate' or greater physical activity(through delivery, an average of 7 months per participant)
- Mean Nightly sleep minutes(through delivery, an average of 7 months per participant)
- Median Nightly sleep minutes(through delivery, an average of 7 months per participant)
- Median Body composition change during study - total body water(through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.)
- Mean Body composition change during study - total body water(through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.)
- Mean 'Moderate' or greater physical activity(through delivery, an average of 7 months per participant)
- Median resting heart rate parameters(through delivery, an average of 7 months per participant)
- Gestational weight gain, per week after study enrollment(through delivery, an average of 7 months per participant)
- Median Body composition change during study - percent body fat(through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.)
- Gestational weight gain(through delivery, an average of 7 months per participant)
- Proportion of women with gestational diabetes mellitus(through delivery, an average of 7 months per participant.)
- Mean Body composition change during study - percent body fat(through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.)