Preeclampsia Clinical Trial
— STEPUPOfficial title:
A Randomized, Clinical Trial Evaluating Methods to Increase Physical Activity After a Pregnancy Complicated by a Hypertensive Disorder
NCT number | NCT04119232 |
Other study ID # | 833609 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 10, 2019 |
Est. completion date | October 5, 2020 |
Verified date | December 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | October 5, 2020 |
Est. primary completion date | June 18, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Proportion of participant-days that step goals are achieved | proportion of days participants meet their step goal | weeks 3 to 14 of the intervention | |
Secondary | Mean daily steps during the 12-week intervention period adjusted for baseline step count | Mean daily steps during the 12-week intervention period adjusted for baseline step count | 12-week intervention period | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change in Systolic blood pressure | weeks 3 to 14 of the intervention | ||
Secondary | Change in Diastolic blood pressure | weeks 3 to 14 of the intervention | ||
Secondary | Change in weight | weeks 3 to 14 of the intervention | ||
Secondary | Change in hypertension diagnosis | weeks 3 to 14 of the intervention | ||
Secondary | Health care utilization (attended postpartum OB visit or postpartum visit with primary care or cardiology) | weeks 3 to 14 of the intervention | ||
Secondary | Change in breastfeeding rates | weeks 3 to 14 of the intervention | ||
Secondary | Change in sleep duration as measured by Fitbit | weeks 3 to 14 of the intervention | ||
Secondary | Moderate or vigorous activity, as measured by Fitbit | weeks 3 to 14 of the intervention |
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