Hypertensive Disorder of PregnancyNCT06019715
Remote Postpartum Intervention Targeting Movement Behaviors After Hypertensive Disorders of Pregnancy
A study testing Postpartum Remote Physical Activity Intervention in people with Hypertensive Disorder of Pregnancy, run by Jackie Dziewior at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Disorder of Pregnancy
- What is being tested?
- Postpartum Remote Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 May 2024
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- <6 months postpartum from a pregnancy complicated by a hypertensive disorder
- Have self-reported insufficient activity (<150 minutes of moderate to vigorous physical activity per week)
- Own a smartphone
Who cannot join
- Current enrollment in another physical activity or sedentary behavior intervention study
- Recommend to limit physical activity by a healthcare provider
- Diagnosed with diabetes, kidney disease, cardiovascular disease
- Prior bariatric surgery
- Currently takes medication to reduce weight or anti-hypertensives
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Conditions
- Hypertensive Disorder of Pregnancy
- Being tested
- Postpartum Remote Physical Activity Intervention
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Remote Physical Activity InterventionBehavioural
Also called The HyPE 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: Postpartum Remote Physical Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
Change in step count from baseline across study timeline
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Change in postpartum blood pressure
Change in postpartum blood pressure from baseline across study timeline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Jun 2023
- Primary completion1 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jackie Dziewior
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jackie Dziewior, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019715
- Sponsor's protocol ID
- 202302470
- Status last verified
- May 2024
- First submitted
- 24 Aug 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melchiorre K, Thilaganathan B, Giorgione V, Ridder A, Memmo A, Khalil A. Hypertensive Disorders of Pregnancy and Future Cardiovascular Health. Front Cardiovasc Med. 2020 Apr 15;7:59. doi: 10.3389/fcvm.2020.00059. eCollection 2020.
PubMed 32351977Diaz KM, Shimbo D. Physical activity and the prevention of hypertension. Curr Hypertens Rep. 2013 Dec;15(6):659-68. doi: 10.1007/s11906-013-0386-8.
PubMed 24052212Evenson KR, Aytur SA, Borodulin K. Physical activity beliefs, barriers, and enablers among postpartum women. J Womens Health (Larchmt). 2009 Dec;18(12):1925-34. doi: 10.1089/jwh.2008.1309.
PubMed 20044854Lane-Cordova AD, Jerome GJ, Paluch AE, Bustamante EE, LaMonte MJ, Pate RR, Weaver RG, Webber-Ritchey KJ, Gibbs BB; Committee on Physical Activity of the American Heart Association Council on Lifestyle and Cardiometabolic Health. Supporting Physical Activity in Patients and Populations During Life Events and Transitions: A Scientific Statement From the American Heart Association. Circulation. 2022 Jan 25;145(4):e117-e128. doi: 10.1161/CIR.0000000000001035. Epub 2021 Dec 1.
PubMed 34847691Lui NA, Jeyaram G, Henry A. Postpartum Interventions to Reduce Long-Term Cardiovascular Disease Risk in Women After Hypertensive Disorders of Pregnancy: A Systematic Review. Front Cardiovasc Med. 2019 Nov 15;6:160. doi: 10.3389/fcvm.2019.00160. eCollection 2019.
PubMed 31803757Whitaker KM, Jones MA, Dziewior J, Anderson M, Anderson C, Gibbs BB, Carr LJ. Feasibility, acceptability, and preliminary efficacy of a single-arm, remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy. BMC Pregnancy Childbirth. 2022 Oct 2;22(1):740. doi: 10.1186/s12884-022-05073-4.
PubMed 36184599Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2002 Apr 2;136(7):493-503. doi: 10.7326/0003-4819-136-7-200204020-00006.
PubMed 11926784Hutchesson M, Campbell L, Leonard A, Vincze L, Shrewsbury V, Collins C, Taylor R. Do modifiable risk factors for cardiovascular disease post-pregnancy influence the association between hypertensive disorders of pregnancy and cardiovascular health outcomes? A systematic review of observational studies. Pregnancy Hypertens. 2022 Mar;27:138-147. doi: 10.1016/j.preghy.2021.12.017. Epub 2022 Jan 6.
PubMed 35066405Mehta LS, Sharma G, Creanga AA, Hameed AB, Hollier LM, Johnson JC, Leffert L, McCullough LD, Mujahid MS, Watson K, White CJ; American Heart Association Advocacy Coordinating Committee. Call to Action: Maternal Health and Saving Mothers: A Policy Statement From the American Heart Association. Circulation. 2021 Oct 12;144(15):e251-e269. doi: 10.1161/CIR.0000000000001000. Epub 2021 Sep 8.
PubMed 34493059
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Postpartum Intervention Targeting Movement Behaviors After Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT06019715
- Acronym / sponsor ID
- 202302470
- Conditions
- Hypertensive Disorder of Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jackie DziewiorUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 31 Aug 2023 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Postpartum Remote Physical Activity InterventionThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- <6 months postpartum from a pregnancy complicated by a hypertensive disorder
- Have self-reported insufficient activity (<150 minutes of moderate to vigorous physical activity per week)
- Own a smartphone
Key exclusion criteria (5 listed)
- Current enrollment in another physical activity or sedentary behavior intervention study
- Recommend to limit physical activity by a healthcare provider
- Diagnosed with diabetes, kidney disease, cardiovascular disease
- Prior bariatric surgery
- Currently takes medication to reduce weight or anti-hypertensives
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 |
|---|---|---|
| Postpartum Remote Physical Activity InterventionAlso: The HyPE InterventionIncludes 8 remote health coaching session to promote physical activity, use of a Fitbit device, and use of a home based blood pressure monitor. | Behavioural | Intervention Arm |
Primary outcome
Change in physical activity
Time frame: 6 months
Change in step count from baseline across study timeline
Intervention feasibility
Time frame: 6 months
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.
Intervention acceptability
Time frame: 6 months
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.
1 secondary outcome
Change in postpartum blood pressure
Time frame: 6 months
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 10 May 2024.
- Background: PubMed 32351977Melchiorre K, Thilaganathan B, Giorgione V, Ridder A, Memmo A, Khalil A. Hypertensive Disorders of Pregnancy and Future Cardiovascular Health. Front Cardiovasc Med. 2020 Apr 15;7:59. doi: 10.3389/fcvm.2020.00059. eCollection 2020.
- Background: PubMed 24052212Diaz KM, Shimbo D. Physical activity and the prevention of hypertension. Curr Hypertens Rep. 2013 Dec;15(6):659-68. doi: 10.1007/s11906-013-0386-8.
- Background: PubMed 20044854Evenson KR, Aytur SA, Borodulin K. Physical activity beliefs, barriers, and enablers among postpartum women. J Womens Health (Larchmt). 2009 Dec;18(12):1925-34. doi: 10.1089/jwh.2008.1309.
- Background: PubMed 34847691Lane-Cordova AD, Jerome GJ, Paluch AE, Bustamante EE, LaMonte MJ, Pate RR, Weaver RG, Webber-Ritchey KJ, Gibbs BB; Committee on Physical Activity of the American Heart Association Council on Lifestyle and Cardiometabolic Health. Supporting Physical Activity in Patients and Populations During Life Events and Transitions: A Scientific Statement From the American Heart Association. Circulation. 2022 Jan 25;145(4):e117-e128. doi: 10.1161/CIR.0000000000001035. Epub 2021 Dec 1.
- Background: PubMed 31803757Lui NA, Jeyaram G, Henry A. Postpartum Interventions to Reduce Long-Term Cardiovascular Disease Risk in Women After Hypertensive Disorders of Pregnancy: A Systematic Review. Front Cardiovasc Med. 2019 Nov 15;6:160. doi: 10.3389/fcvm.2019.00160. eCollection 2019.
- Background: PubMed 36184599Whitaker KM, Jones MA, Dziewior J, Anderson M, Anderson C, Gibbs BB, Carr LJ. Feasibility, acceptability, and preliminary efficacy of a single-arm, remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy. BMC Pregnancy Childbirth. 2022 Oct 2;22(1):740. doi: 10.1186/s12884-022-05073-4.
- Background: PubMed 11926784Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2002 Apr 2;136(7):493-503. doi: 10.7326/0003-4819-136-7-200204020-00006.
- Background: PubMed 35066405Hutchesson M, Campbell L, Leonard A, Vincze L, Shrewsbury V, Collins C, Taylor R. Do modifiable risk factors for cardiovascular disease post-pregnancy influence the association between hypertensive disorders of pregnancy and cardiovascular health outcomes? A systematic review of observational studies. Pregnancy Hypertens. 2022 Mar;27:138-147. doi: 10.1016/j.preghy.2021.12.017. Epub 2022 Jan 6.
- Background: PubMed 34493059Mehta LS, Sharma G, Creanga AA, Hameed AB, Hollier LM, Johnson JC, Leffert L, McCullough LD, Mujahid MS, Watson K, White CJ; American Heart Association Advocacy Coordinating Committee. Call to Action: Maternal Health and Saving Mothers: A Policy Statement From the American Heart Association. Circulation. 2021 Oct 12;144(15):e251-e269. doi: 10.1161/CIR.0000000000001000. Epub 2021 Sep 8.
- 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 Postpartum Remote Physical Activity Intervention in people with Hypertensive Disorder of Pregnancy, run by Jackie Dziewior 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 3 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 10 May 2024. 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 physical activity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019715, which also lists 9 linked publications.
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 10 May 2024.