Patient Portal Messaging
BehavioralParticipants will receive weekly messages via their patient portal including feedback on their step counts and step count goals based on data from their FitBits
NCT Number: NCT07127731
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Participants will receive FitBits and link this step count data with the Electronic Health Record (EHR)
Time frame: From enrollment to the end of the 24 week intervention
Number of participants enrolled in the intervention
Time frame: At study weeks 12 and 24
Percent of enrolled participants who continue to participate in the intervention
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
Time frame: From enrollment to the end of the 24 week intervention
Percent of weekly messages that are read by participants
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).
Time frame: Study weeks 0, 12 and 24
Systolic blood pressure (mmHg)
Time frame: Study weeks 0, 12 and 24
Diastolic Blood Pressure (mmHg)
Time frame: Study weeks 0, 12 and 24
Daily Mean Step Count from FitBits
Time frame: Study weeks 0, 12 and 24
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
Body weight (kg)
Time frame: Baseline
Height in inches
Time frame: Study weeks 0, 12 and 24
Mean hours of sleep per night
Time frame: Study weeks 0, 12 and 24
Adherence to Mediterranean diet assessed by the Mediterranean Eating Pattern for Americans Tool
Time frame: Study weeks 0, 12 and 24
Score on the Edinburgh Postnatal Depression Scale. Minimum Score: 0 (Least Depressed), Maximum Score: 30 (Most Depressed)
Time frame: Study weeks 0, 12 and 24
Score on the Perceived Stress Scale. Minimum Score: 0 (Least Perceived Stress), Maximum Score: 40 (Most Perceived Stress)
Time frame: Study weeks 0, 12 and 24
Score on the Generalized Anxiety Disorder - 7 Scale. Minimum Score: 0 (Little Anxiety), Maximum Score: 21 (Severe Anxiety)
Time frame: Study weeks 0, 12 and 24
Participants will be asked a multiple choice question with 5 possible options about how many minutes per week of exercise is recommended by the government. One option will be considered the correct answer.
Time frame: Study weeks 0, 12 and 24
Participants will be asked to write a response to the following question: Above which blood pressure does the American Heart Association say someone has hypertension?
Time frame: From enrollment through the end of the 24 week intervention
Number and type of healthcare visits attended
Time frame: Study weeks 0, 12 and 24
Score on the PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance Short Form. Minimum Score: 8 (low levels of sleep disturbance; Maximum Score: 40 (high levels of sleep disturbance)
Time frame: From enrollment through the end of the 24 week intervention
Number of times participant reports receiving physical activity counseling from a healthcare provider
Time frame: From enrollment through the end of the 24 week intervention
Number of times participant reports discussing their FitBit data with a healthcare provider
Contact information is provided by the study sponsor or research team.
Northwestern University
Other
REACH BP: REmote Physical ACtivity Intervention for High Blood Pressure Postpartum
Acronym: REACH BP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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