Remote Postpartum Intervention Targeting Movement Behaviors After Hypertensive Disorders of Pregnancy

NCT06019715 | Completed

• 1 other identifier: 202302470
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Disorder of Pregnancy

Outcome Measures

Primary Outcomes (3)

• Change in physical activity

  Change in step count from baseline across study timeline

  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.

  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.

  6 months

Secondary Outcomes (1)

• Change in postpartum blood pressure

  6 months

Study Arms (1)

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.

Behavioral: Postpartum Remote Physical Activity Intervention

Interventions

Postpartum Remote Physical Activity Intervention BEHAVIORAL

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \<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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jackie Dziewior: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (9)

• 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.

  PMID: 32351977 BACKGROUND

• 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.

  PMID: 24052212 BACKGROUND

• 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.

  PMID: 20044854 BACKGROUND

• 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.

  PMID: 34847691 BACKGROUND

• 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.

  PMID: 31803757 BACKGROUND

• 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.

  PMID: 36184599 BACKGROUND

• 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.

  PMID: 11926784 BACKGROUND

• 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.

  PMID: 35066405 BACKGROUND

• 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.

  PMID: 34493059 BACKGROUND

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 31, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)