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Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy

NCT ID: NCT04119232

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2020-10-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension in Pregnancy Preeclampsia Gestational Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Social incentives-based program

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.

Group Type EXPERIMENTAL

Social incentives-based program

Intervention Type 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.

Interventions

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Social incentives-based program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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833609

Identifier Type: -

Identifier Source: org_study_id