search
Back to results

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

Primary Purpose

Hypertension in Pregnancy, Preeclampsia, Gestational Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social incentives-based program
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension in Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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).

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Social incentives-based program

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Proportion of participant-days that step goals are achieved
proportion of days participants meet their step goal
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
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.
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
Change in Systolic blood pressure
Change in Diastolic blood pressure
Change in weight
Change in hypertension diagnosis
Health care utilization (attended postpartum OB visit or postpartum visit with primary care or cardiology)
Change in breastfeeding rates
Change in sleep duration as measured by Fitbit
Moderate or vigorous activity, as measured by Fitbit

Full Information

First Posted
October 7, 2019
Last Updated
December 11, 2020
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT04119232
Brief Title
Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy
Acronym
STEPUP
Official Title
A Randomized, Clinical Trial Evaluating Methods to Increase Physical Activity After a Pregnancy Complicated by a Hypertensive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
June 18, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Preeclampsia, Gestational Hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will conduct a two-arm randomized, controlled trial comparing a control group that uses wearable devices to track physical activity to an intervention group that uses the same wearable devices and participates in a team-based model of social incentives that gamifies physical activity. Patients will be randomized to one of the two arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Social incentives-based program
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Social incentives-based program
Intervention 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.
Primary Outcome Measure Information:
Title
Change in mean daily steps
Description
Change in mean daily step count from the baseline period (weeks 1-2) to the intervention period (weeks 3-14)
Time Frame
weeks 3 to 14 of the intervention
Secondary Outcome Measure Information:
Title
Proportion of participant-days that step goals are achieved
Description
proportion of days participants meet their step goal
Time Frame
weeks 3 to 14 of the intervention
Title
Mean daily steps during the 12-week intervention period adjusted for baseline step count
Description
Mean daily steps during the 12-week intervention period adjusted for baseline step count
Time Frame
12-week intervention period
Title
Change in perceived social support scale
Description
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.
Time Frame
weeks 3 to 14 of the intervention
Title
Change in Edinburgh postnatal depression scale (EPDS)
Description
Change in Edinburgh postnatal depression scale (EPDS): scored 0-30 with a score of 10 or greater indicating depressive symptoms
Time Frame
weeks 3 to 14 of the intervention
Title
Change in Systolic blood pressure
Time Frame
weeks 3 to 14 of the intervention
Title
Change in Diastolic blood pressure
Time Frame
weeks 3 to 14 of the intervention
Title
Change in weight
Time Frame
weeks 3 to 14 of the intervention
Title
Change in hypertension diagnosis
Time Frame
weeks 3 to 14 of the intervention
Title
Health care utilization (attended postpartum OB visit or postpartum visit with primary care or cardiology)
Time Frame
weeks 3 to 14 of the intervention
Title
Change in breastfeeding rates
Time Frame
weeks 3 to 14 of the intervention
Title
Change in sleep duration as measured by Fitbit
Time Frame
weeks 3 to 14 of the intervention
Title
Moderate or vigorous activity, as measured by Fitbit
Time Frame
weeks 3 to 14 of the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs