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

Not Applicable

Completed

• Conditions: Hypertension in Pregnancy; Preeclampsia; Gestational Hypertension
• Interventions: Behavioral: Social incentives-based program

• Registration Number: NCT04119232
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-08
• Study Start: 2019-10-10
• Primary Completion: 2020-06-18
• Study Completion: 2020-10-05
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social incentives-based program	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.

Primary Outcome Measures

Name	Time	Method
Change in mean daily steps	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)

Secondary Outcome Measures

Name	Time	Method
Proportion of participant-days that step goals are achieved	weeks 3 to 14 of the intervention	proportion of days participants meet their step goal
Mean daily steps during the 12-week intervention period adjusted for baseline step count	12-week intervention period	Mean daily steps during the 12-week intervention period adjusted for baseline step count
Change in perceived social support scale	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.
Change in Edinburgh postnatal depression scale (EPDS)	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
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 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
Change in weight	weeks 3 to 14 of the intervention

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States