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

Overview

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 Title of Study: “A Randomized, Clinical Trial Evaluating Methods to Increase Physical Activity After a Pregnancy Complicated by a Hypertensive Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in mean daily steps
    • Time Frame: 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 Measures

  • Proportion of participant-days that step goals are achieved
    • Time Frame: 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
    • Time Frame: 12-week intervention period
    • Mean daily steps during the 12-week intervention period adjusted for baseline step count
  • Change in perceived social support scale
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: weeks 3 to 14 of the intervention
  • Change in Diastolic blood pressure
    • Time Frame: weeks 3 to 14 of the intervention
  • Change in weight
    • Time Frame: weeks 3 to 14 of the intervention
  • Change in hypertension diagnosis
    • Time Frame: weeks 3 to 14 of the intervention
  • Health care utilization (attended postpartum OB visit or postpartum visit with primary care or cardiology)
    • Time Frame: weeks 3 to 14 of the intervention
  • Change in breastfeeding rates
    • Time Frame: weeks 3 to 14 of the intervention
  • Change in sleep duration as measured by Fitbit
    • Time Frame: weeks 3 to 14 of the intervention
  • Moderate or vigorous activity, as measured by Fitbit
    • Time Frame: weeks 3 to 14 of the intervention

Participating in This Clinical Trial

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).

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Valerie Riis, MS, 2154989099, valerie.riis@pennmedicine.upenn.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.