Clinical trial NCT04119232: Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy
Official title: A Randomized, Clinical Trial Evaluating Methods to Increase Physical Activity After a Pregnancy Complicated by a Hypertensive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension in Pregnancy
Preeclampsia
Gestational Hypertension
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: Change in mean daily steps
timeFrame: weeks 3 to 14 of the intervention
Secondary outcomes:
measure: Proportion of participant-days that step goals are achieved
timeFrame: weeks 3 to 14 of the intervention
measure: Mean daily steps during the 12-week intervention period adjusted for baseline step count
timeFrame: 12-week intervention period
measure: Change in perceived social support scale
timeFrame: weeks 3 to 14 of the intervention
measure: Change in Edinburgh postnatal depression scale (EPDS)
timeFrame: weeks 3 to 14 of the intervention
measure: Change in Systolic blood pressure
timeFrame: weeks 3 to 14 of the intervention
measure: Change in Diastolic blood pressure
timeFrame: weeks 3 to 14 of the intervention
measure: Change in weight
timeFrame: weeks 3 to 14 of the intervention
measure: Change in hypertension diagnosis
timeFrame: weeks 3 to 14 of the intervention
measure: Health care utilization (attended postpartum OB visit or postpartum visit with primary care or cardiology)
timeFrame: weeks 3 to 14 of the intervention
measure: Change in breastfeeding rates
timeFrame: weeks 3 to 14 of the intervention
measure: Change in sleep duration as measured by Fitbit
timeFrame: weeks 3 to 14 of the intervention
measure: Moderate or vigorous activity, as measured by Fitbit
timeFrame: weeks 3 to 14 of the intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References: