Hypertension in PregnancySTEPUPNCT04119232
Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy
A study testing Social incentives-based program in people with Hypertension in Pregnancy and Preeclampsia, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension in Pregnancy, Preeclampsia, Gestational Hypertension
- What is being tested?
- Social incentives-based program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Being tested
- Social incentives-based program
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social incentives-based programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Social incentives-based program | Experimental | 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. Receives: Behavioral: Social incentives-based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: weeks 3 to 14 of the intervention
Secondary outcomes (12)
Proportion of participant-days that step goals are achieved
proportion of days participants meet their step goal
Measured: 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
Measured: 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.
Measured: 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
Measured: weeks 3 to 14 of the intervention
Change in Systolic blood pressure
Measured: weeks 3 to 14 of the intervention
Change in Diastolic blood pressure
Measured: weeks 3 to 14 of the intervention
Change in weight
Measured: weeks 3 to 14 of the intervention
Change in hypertension diagnosis
Measured: weeks 3 to 14 of the intervention
Health care utilization (attended postpartum OB visit or postpartum visit with primary care or cardiology)
Measured: weeks 3 to 14 of the intervention
Change in breastfeeding rates
Measured: weeks 3 to 14 of the intervention
Change in sleep duration as measured by Fitbit
Measured: weeks 3 to 14 of the intervention
Moderate or vigorous activity, as measured by Fitbit
Measured: weeks 3 to 14 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start10 Oct 2019
- Primary completion18 Jun 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119232
- Sponsor's protocol ID
- 833609
- Acronym
- STEPUP
- Status last verified
- Dec 2020
- First submitted
- 7 Oct 2019
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Clinical Trial Evaluating Methods to Increase Physical Activity After a Pregnancy Complicated by a Hypertensive Disorder
- ClinicalTrials.gov ID
- NCT04119232
- Acronym / sponsor ID
- STEPUP / 833609
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Social incentives-based program | Experimental | Behavioral: Social incentives-based programIndividual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social incentives-based programIndividual 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. | Behavioural | Social incentives-based program |
Primary outcome
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)
12 secondary outcomes
Proportion of participant-days that step goals are achieved
Time frame: weeks 3 to 14 of the intervention
Mean daily steps during the 12-week intervention period adjusted for baseline step count
Time frame: 12-week intervention period
Change in perceived social support scale
Time frame: weeks 3 to 14 of the intervention
Change in Edinburgh postnatal depression scale (EPDS)
Time frame: weeks 3 to 14 of the intervention
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social incentives-based program in people with Hypertension in Pregnancy and Preeclampsia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean daily steps (time frame: weeks 3 to 14 of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.