Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT04119232
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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)
Time frame: weeks 3 to 14 of the intervention
proportion of days participants meet their step goal
Time frame: 12-week intervention period
Mean daily steps during the 12-week intervention period adjusted for baseline step count
Time frame: weeks 3 to 14 of the intervention
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.
Time frame: weeks 3 to 14 of the intervention
Change in Edinburgh postnatal depression scale (EPDS): scored 0-30 with a score of 10 or greater indicating depressive symptoms
Time frame: weeks 3 to 14 of the intervention
Time frame: weeks 3 to 14 of the intervention
Time frame: weeks 3 to 14 of the intervention
Time frame: weeks 3 to 14 of the intervention
Time frame: weeks 3 to 14 of the intervention
Time frame: weeks 3 to 14 of the intervention
Time frame: weeks 3 to 14 of the intervention
Time frame: weeks 3 to 14 of the intervention
University of Pennsylvania
Other
A Randomized, Clinical Trial Evaluating Methods to Increase Physical Activity After a Pregnancy Complicated by a Hypertensive Disorder
Acronym: STEPUP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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