Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy (STEPUP)

University of Pennsylvania

Status: Completed

Conditions: Preeclampsia; Gestational Hypertension; Hypertension in Pregnancy

Treatments: Behavioral: Social incentives-based program

Study type: Interventional

Funder types: Other

Identifiers

NCT04119232

833609

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 128 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Social incentives-based program