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

A Randomized, Clinical Trial Evaluating Methods to Increase Physical Activity After a Pregnancy Complicated by a Hypertensive Disorder

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia; Hypertension in Pregnancy; Gestational Hypertension
• Intervention / Treatment: Behavioral: Social incentives-based program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): June 18, 2020
• Study Completion (Actual): October 5, 2020

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 833609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No