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Clinical Trials/NCT07127731
NCT07127731Not yet recruitingNot Applicable

REACH BP: REmote Physical ACtivity Intervention for High Blood Pressure Postpartum

Northwestern University0 sites60 target enrollmentStarted: April 1, 2027Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Feasibility of Recruitment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Arms & Interventions

Experimental Group

Experimental

Intervention: Patient Portal Messaging (Behavioral)

Experimental Group

Experimental

Intervention: FitBit EHR Linkage (Behavioral)

Control Group

Active Comparator

Intervention: FitBit EHR Linkage (Behavioral)

Outcomes

Primary Outcomes

Feasibility of Recruitment

Time Frame: From enrollment to the end of the 24 week intervention

Number of participants enrolled in the intervention

Feasibility of Participant Retention

Time Frame: At study weeks 12 and 24

Percent of enrolled participants who continue to participate in the intervention

Acceptability of the Intervention

Time Frame: Study week 24

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).

Feasibility of FitBit+EHR linkage

Time Frame: From enrollment to the end of the 24 week intervention

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

Feasibility of Intervention Messaging

Time Frame: From enrollment to the end of the 24 week intervention

Percent of weekly messages that are read by participants

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Natalie Cameron

Instructor

Northwestern University

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