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Completed

NCT Number: NCT04119232

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Social incentives-based program

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. Change in Systolic blood pressure

    Time frame: weeks 3 to 14 of the intervention

  6. Change in Diastolic blood pressure

    Time frame: weeks 3 to 14 of the intervention

  7. Change in weight

    Time frame: weeks 3 to 14 of the intervention

  8. Change in hypertension diagnosis

    Time frame: weeks 3 to 14 of the intervention

  9. Health care utilization (attended postpartum OB visit or postpartum visit with primary care or cardiology)

    Time frame: weeks 3 to 14 of the intervention

  10. Change in breastfeeding rates

    Time frame: weeks 3 to 14 of the intervention

  11. Change in sleep duration as measured by Fitbit

    Time frame: weeks 3 to 14 of the intervention

  12. Moderate or vigorous activity, as measured by Fitbit

    Time frame: weeks 3 to 14 of the intervention

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: STEPUP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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