An interventional study of Postpartum Remote Physical Activity Intervention in Hypertensive Disorder of Pregnancy, sponsored by Jackie Dziewior. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Jackie Dziewior · Not applicable, Interventional, and Prevention
The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a postpartum physical activity intervention after a pregnancy complicated by a Hypertensive Disorder of Pregnancy. The study will also assess the effects of the remote postpartum intervention on blood pressure. To do this, we will recruit individuals that are 3-6 months postpartum a pregnancy complicated by a hypertensive disorder to participate in a 4-month health coaching intervention aimed to promote physical activity and was informed by formative work done previously.
I.a Clinical and Public Health Significance. CVD is the leading cause of death among women in America; one in four of these deaths are preventable.3 HDP, including gestational and chronic hypertension, preeclampsia, and superimposed preeclampsia, are risk factors for CVD.3 HDP are associated with maternal and offspring morbidity and mortality, negatively impacting cardiovascular, immune, and neurological systems.21 With 10% of all pregnancies affected by HDP, targeting this population is critical to improving maternal/neonatal morbidity and mortality and overall cardiovascular health in America.1,2 The proposed study answers the AHA's call in their 2022 scientific statement for studies demonstrating efficacy of lifestyle interventions addressing hypertension during the postpartum period among those with HDP.22
I.b Cardiovascular changes during pregnancy act as a natural stress test and may uncover an individual's potential risk of future CVD.23 Specifically, individuals with HDP are at an immediately increased risk for HTN after delivery.1 Long-term cardiometabolic health is also implicated by HDP, with increased risk of future CVD, morbidity, and mortality compared to normotensive pregnancies.24 Odds of developing HTN at one year postpartum is 12 to 25 times greater in HDP pregnancies compared to normotensive pregnancies.25 The 5-year likelihood of developing HTN for pregnancies complicated by HDP is 7.1 times greater than normotensive pregnancies.1 Even in those not diagnosed with HTN, the BP is on average greater in HDP women than in normotensive pregnancies.26
I.c Follow-up care for HDP in the postpartum period is inadequate. Although it is understood that HDP place an individual at increased risk for future CVD, only 58% of women with HDP had a 7-10 day postpartum BP check and 48% for a 6-month postpartum visit.4,25 In addition, only 17% of women with HDP follow-up with their primary care providers, indicating a gap in the transition of care after pregnancy.25 Lack of follow-up has been attributed to fatigue, pain, infant care obligations, time, and low awareness of HDP as a risk factor for future CVD.27,28 Although a few interventions have targeted future CVD risk in this population, few to no studies account for these unique barriers experienced during the postpartum period.14,29
I.d PA and SED have independent effects on CVD risk.8-10 PA and SED are modifiable risk factors for CVD and have the potential to improve BP.30 Current studies suggest that moderate to vigorous PA decreases after pregnancy, and evidence concerning SED is conflicting.31,32 PA, specifically aerobic exercise, has beneficial effects on mean, systolic, and diastolic BP in adults.33,34 This association has been observed in pregnant populations as well, with the greatest improvements seen in inactive individuals.35,36 SED is another modifiable risk factor associated with CVD, independent of PA, with each additional hour of SED increasing the risk for HTN.8 Although the effect on PA and SED in the general population are well understood, the direct effects of PA/SED in the postpartum period on BP after HDP is understudied.37
I.e The perinatal period presents a critical period of change and a promising target for lifestyle intervention to reduce future CVD risk. The association of HDP with future CVD elicited AHA's call to action for more vigorous primary prevention of CVD in the postpartum period.38,39 With increased contact to health care professionals during gestation, pregnancy also offers an opportunity to connect with this population to develop positive health behaviors, which our preliminary data confirms is feasible. Interventions promoting PA and decreased SED in the postpartum period after a HDP is an under explored primary prevention strategy.37
933 studies on the registry are indexed under Toxemia; 153 are open to participants now.
This study's enrollment of 20 is below the median of 112 across 438 interventional studies indexed under Toxemia.
Browse Toxemia studies →This is the only study on the registry with Jackie Dziewior as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm will receive the full intervention, including 4 months of health coaching support, 8 virtual health coaching visits, a Fitbit device, and an at home blood pressure monitor.
Behavioral: Postpartum Remote Physical Activity Intervention
Includes 8 remote health coaching session to promote physical activity, use of a Fitbit device, and use of a home based blood pressure monitor.
Also known as: The HyPE Intervention
Change in physical activity
Change in step count from baseline across study timeline
Time frame: 6 months
Intervention feasibility
Will be evaluated using Bowen's standards, specifically implementation and practicality. Implementation and practicability will be measured by the number of completed sessions out of the total session possible and by the quality of implementation through participant self-reported satisfaction of the program's session length, frequency, and topics covered.
Time frame: 6 months
Intervention acceptability
Will be evaluated using Bowen's standards, specifically acceptability and demand of the intervention. Acceptability and demand will be assessed by participant self-reported satisfaction and likelihood to recommend the program to other of participants. Acceptability, demand, and practicality will be defined by at least 75% of participants responding either satisfied or very satisfied to these questions; implementation by 75% of sessions attended.
Time frame: 6 months
Change in postpartum blood pressure
Change in postpartum blood pressure from baseline across study timeline
Time frame: 6 months
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.