A Randomized, Clinical Trial Evaluating Methods to Increase Physical Activity After a Pregnancy Complicated by a Hypertensive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Change in mean daily steps
研究概览
简要总结
STEPUP is a 12-week randomized clinical trial among 126 postpartum women with pregnancies complicated by hypertensive disorders. Participants will be randomized to a control arm and receive a Fitbit or an intervention arm. The intervention arm will receive a Fitbit and set a step count goal, receive daily feedback via text about whether they reached their goal, and will be placed in virtual teams with other participants where they can win points for their team if they meet their daily goals. The main study outcomes will be increase in mean step count and change in psychosocial survey measures.
详细描述
Women with hypertensive disorders of pregnancy, such as preeclampsia and gestational hypertension, are at elevated risk of developing hypertension, diabetes, heart failure, and premature atherosclerotic cardiovascular disease. Current guidelines recommend intensive lifestyle modification for women with a history of hypertensive disorders in pregnancy in order to reduce the risk of developing cardiometabolic risk factors or overt CV disease. However, limited research exists to guide how to implement lifestyle modification for this population. The postpartum period poses unique challenges to adopting a healthy lifestyle. Remote interventions using mobile technology may be particularly effective. Social incentives designed using insights from behavioral economics have been demonstrated to motivate health behavior change, such as increasing physical activity. The objective of this study is to use a randomized clinical trial to test the effectiveness of a 12-week team-based, mobile health interventions using wearable devices and social incentives to increase physical activity in the postpartum period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Delivered a live baby at HUP or PAH within 4.0-12.6 weeks prior to study enrollment;
- •Diagnosis of chronic hypertension, gestational hypertension, or preeclampsia during most recent pregnancy;
- •Participating in Heart Safe Motherhood (HSM) program;
- •Ability to read and provide informed consent to participate in the study;
- •Has smartphone and email address
排除标准
- •Does not speak English
- •Answers yes to any of the following questions:
- •Are you currently participating in any other physical activity studies?
- •Do you have any medical conditions or other reasons why you could not participate in a 12-week physical activity program?
- •Participants will be excluded after completing the baseline period if their baseline step count is too high (greater than or equal to 10,000 steps per day).
结局指标
主要结局
Change in mean daily steps
时间窗: weeks 3 to 14 of the intervention
Change in mean daily step count from the baseline period (weeks 1-2) to the intervention period (weeks 3-14)
次要结局
- Proportion of participant-days that step goals are achieved(weeks 3 to 14 of the intervention)
- Mean daily steps during the 12-week intervention period adjusted for baseline step count(12-week intervention period)
- Change in perceived social support scale(weeks 3 to 14 of the intervention)
- Change in Edinburgh postnatal depression scale (EPDS)(weeks 3 to 14 of the intervention)
- Change in Systolic blood pressure(weeks 3 to 14 of the intervention)
- Change in Diastolic blood pressure(weeks 3 to 14 of the intervention)
- Change in weight(weeks 3 to 14 of the intervention)
- Change in hypertension diagnosis(weeks 3 to 14 of the intervention)
- Health care utilization (attended postpartum OB visit or postpartum visit with primary care or cardiology)(weeks 3 to 14 of the intervention)
- Change in breastfeeding rates(weeks 3 to 14 of the intervention)
- Change in sleep duration as measured by Fitbit(weeks 3 to 14 of the intervention)
- Moderate or vigorous activity, as measured by Fitbit(weeks 3 to 14 of the intervention)