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REmote Physical ACtivity Intervention for High Blood Pressure Postpartum

ConditionsHypertension (HTN)Hypertension ,PregnancyPhysical Activity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • FitBit EHR Linkage

    Behavioral

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Recruitment

Number of participants enrolled in the intervention

Time frame
From enrollment to the end of the 24 week intervention
2

Feasibility of Participant Retention

Percent of enrolled participants who continue to participate in the intervention

Time frame
At study weeks 12 and 24
3

Feasibility of FitBit+EHR linkage

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

Time frame
From enrollment to the end of the 24 week intervention
4

Feasibility of Intervention Messaging

Percent of weekly messages that are read by participants

Time frame
From enrollment to the end of the 24 week intervention

Secondary outcomes

Other outcomes

1

Systolic Blood Pressure

Systolic blood pressure (mmHg)

Time frame
Study weeks 0, 12 and 24
2

Diastolic Blood Pressure

Diastolic Blood Pressure (mmHg)

Time frame
Study weeks 0, 12 and 24
3

Step Counts

Daily Mean Step Count from FitBits

Time frame
Study weeks 0, 12 and 24
4

Self Reported Physical Activity

Self-reported Metabolic Equivalent of a Task (MET)\*hours per week based on responses to the Pregnancy Physical Activity Questionnaire

Time frame
Study weeks 0, 12 and 24

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: