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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Individual participants will use a wearable device to monitor daily step counts, set a step goal, and receive automated daily feedback on step goal attainment. | |
| Social incentives-based program | Experimental | Individual participants will use a wearable device to monitor daily step counts, set a step goal, and receive automated daily feedback on step goal attainment. Participants will be placed on a team of 3 randomly assigned participants and receive the social incentives intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social incentives-based program | Behavioral | Individual participants will use a wearable device to monitor daily step counts, set a step goal, and receive automated daily feedback on step goal attainment. Participants will be placed on a team of 3 randomly assigned participants and receive the social incentives intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean daily steps | Change in mean daily step count from the baseline period (weeks 1-2) to the intervention period (weeks 3-14) | weeks 3 to 14 of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participant-days that step goals are achieved | proportion of days participants meet their step goal | weeks 3 to 14 of the intervention |
| Mean daily steps during the 12-week intervention period adjusted for baseline step count |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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We will conduct a two-arm randomized, controlled trial comparing a control group that uses wearable devices to track physical activity to an intervention group that uses the same wearable devices and participates in a team-based model of social incentives that gamifies physical activity. Patients will be randomized to one of the two arms.
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|
Mean daily steps during the 12-week intervention period adjusted for baseline step count
| 12-week intervention period |
| Change in perceived social support scale | As measured by the "multidimensional scale of perceived social support", MS-PSS -- a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other. Scored 1-12, with 1 having the lowest support and 12 having high support. | weeks 3 to 14 of the intervention |
| Change in Edinburgh postnatal depression scale (EPDS) | Change in Edinburgh postnatal depression scale (EPDS): scored 0-30 with a score of 10 or greater indicating depressive symptoms | 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |