REmote Physical ACtivity Intervention for High Blood Pressure Postpartum

NCT07127731 | Not Yet Recruiting

• 2 other identifiers: STU0022438125CDA1449707
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this intervention is to help new mothers who had elevated blood pressure during pregnancy become more physically active after birth. The investigators will connect data from FitBits to the electronic health record. Women will then get weekly messages with feedback and goals to help them stay active. The investigators will test if the intervention improves step counts and blood pressure after pregnancy. The investigators will also test if the intervention is feasible and enjoyed by postpartum women.

Conditions

Hypertension (HTN); Hypertension ,Pregnancy; Physical Activity

Keywords

hypertension; pregnancy; postpartum; physical activity

Outcome Measures

Primary Outcomes (5)

• Feasibility of Recruitment

  Number of participants enrolled in the intervention

  From enrollment to the end of the 24 week intervention

• Feasibility of Participant Retention

  Percent of enrolled participants who continue to participate in the intervention

  At study weeks 12 and 24

• Feasibility of FitBit+EHR linkage

  Percent of intervention days FitBit data are linked to the Electronic Health Record

  From enrollment to the end of the 24 week intervention

• Feasibility of Intervention Messaging

  Percent of weekly messages that are read by participants

  From enrollment to the end of the 24 week intervention

• Acceptability of the Intervention

  Participants will fill out a survey to assess the extent to which they were satisfied with individual intervention components including FitBit usage, portal messaging, blood pressure and weight assessments, surveys, intervention length and intervention delivery. Each component will be rated on a 5-point Likert Scale in which 1 represents very dissatisfied (lowest score) and 5 represents very satisfied (highest score).

  Study week 24

Other Outcomes (17)

• Systolic Blood Pressure

  Study weeks 0, 12 and 24

• Diastolic Blood Pressure

  Study weeks 0, 12 and 24

• Step Counts

  Study weeks 0, 12 and 24

Study Arms (2)

Experimental Group

EXPERIMENTAL

Behavioral: Patient Portal Messaging; Behavioral: FitBit EHR Linkage

Control Group

ACTIVE COMPARATOR

Behavioral: FitBit EHR Linkage

Interventions

Patient Portal Messaging BEHAVIORAL

Participants will receive weekly messages via their patient portal including feedback on their step counts and step count goals based on data from their FitBits

Experimental Group

FitBit EHR Linkage BEHAVIORAL

Participants will receive FitBits and link this step count data with the Electronic Health Record (EHR)

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Delivery of a live birth at Northwestern Medicine 6-12 weeks prior
• Systolic blood pressure 120-139 or diastolic blood pressure 80-89 during the first 20 weeks of gestation
• Low self-reported physical activity levels
• Able to access the internet at least weekly
• Have patient portal account or willing to set one up
• Willing to wear a FitBit
• Spoken and written English or Spanish language fluency

You may not qualify if:

• Medical contraindications to participating in a structured physical activity program
• Currently participating in a structured physical activity or weight loss program
• Hypertensive disorder of pregnancy (e.g., preeclampsia, gestational hypertension, eclampsia)

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Hypertension; Hypertension, Pregnancy-Induced; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Central Study Contacts

Natalie A Cameron, MD, MPH

CONTACT

312-503-2137; natalie.cameron@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 17, 2025
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share