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Remote Postpartum Intervention Targeting Movement Behaviors After Hypertensive Disorders of Pregnancy

Primary Purpose

Hypertensive Disorder of Pregnancy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Postpartum Remote Physical Activity Intervention
Sponsored by
Jackie Dziewior
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertensive Disorder of Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: <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 Exclusion Criteria: 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

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in physical activity
Change in step count from baseline across study timeline
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.
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.

Secondary Outcome Measures

Change in postpartum blood pressure
Change in postpartum blood pressure from baseline across study timeline

Full Information

First Posted
August 24, 2023
Last Updated
August 30, 2023
Sponsor
Jackie Dziewior
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1. Study Identification

Unique Protocol Identification Number
NCT06019715
Brief Title
Remote Postpartum Intervention Targeting Movement Behaviors After Hypertensive Disorders of Pregnancy
Official Title
Remote Postpartum Intervention Targeting Movement Behaviors After Hypertensive Disorders of Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jackie Dziewior

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disorder of Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Postpartum Remote Physical Activity Intervention
Other Intervention Name(s)
The HyPE Intervention
Intervention Description
Includes 8 remote health coaching session to promote physical activity, use of a Fitbit device, and use of a home based blood pressure monitor.
Primary Outcome Measure Information:
Title
Change in physical activity
Description
Change in step count from baseline across study timeline
Time Frame
6 months
Title
Intervention feasibility
Description
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
Title
Intervention acceptability
Description
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
Secondary Outcome Measure Information:
Title
Change in postpartum blood pressure
Description
Change in postpartum blood pressure from baseline across study timeline
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: <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 Exclusion Criteria: 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
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32351977
Citation
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.
Results Reference
background
PubMed Identifier
24052212
Citation
Diaz 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.
Results Reference
background
PubMed Identifier
20044854
Citation
Evenson 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.
Results Reference
background
PubMed Identifier
34847691
Citation
Lane-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.
Results Reference
background
PubMed Identifier
31803757
Citation
Lui 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.
Results Reference
background
PubMed Identifier
36184599
Citation
Whitaker 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.
Results Reference
background
PubMed Identifier
11926784
Citation
Whelton 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.
Results Reference
background
PubMed Identifier
35066405
Citation
Hutchesson 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.
Results Reference
background
PubMed Identifier
34493059
Citation
Mehta 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.
Results Reference
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Remote Postpartum Intervention Targeting Movement Behaviors After Hypertensive Disorders of Pregnancy

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